Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
330
Countries
8
Sites
46
Type 1 diabetes mellitus
The primary objective is to evaluate the effect of three doses of Diamyd compared to placebo in terms of (1) beta cell function; and (2) glycemic control in adolescents and adults recently diagnosed with T1D, who carry the (HLA) DR3-DQ2 haplotype and have antibodies against GAD65.
Key facts
- Sponsor
- Diamyd Medical AB
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 17 Mar 2022 → 10 Apr 2026
- Decision date (initial)
- 2024-07-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Diamyd Medical AB
External identifiers
- EU CT number
- 2024-513304-33-00
- EudraCT number
- 2021-002731-32
- ClinicalTrials.gov
- NCT05018585
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The primary objective is to evaluate the effect of three doses of Diamyd compared to placebo in terms of (1) beta cell function; and (2) glycemic control in adolescents and adults recently diagnosed with T1D, who carry the (HLA) DR3-DQ2 haplotype and have antibodies against GAD65.
Secondary objectives 2
- To compare the effect of Diamyd to placebo treatment with respect to the effects on important diabetes disease management indicators.
- To compare the safety of Diamyd to placebo treatment.
Conditions and MedDRA coding
Type 1 diabetes mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045228 | Type I diabetes mellitus | 10027433 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-000609-PIP01-09
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- 1. Must be capable of providing written, signed, and dated informed consent; and for patients who are minors, age-appropriate assent (performed according to local regulations) and parent/caregiver consent
- 9(i). Females of childbearing potential (FOCBP) must agree to avoid pregnancy and have a negative pregnancy test performed at the required trial visits. FOCBP must agree to use highly effective contraception, during treatment and, until 90 days after the last administration of trial medication. Birth control methods, which may be considered as highly effective (e.g., a failure rate of less than 1% per year when used consistently and correctly) include: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o Oral. o Intravaginal. o Transdermal. • Progestogen-only hormonal contraception associated with inhibition of ovulation: o Oral. o Injectable. o Implantable. • Intrauterine device. • Intrauterine hormone-releasing system. • Bilateral tubal occlusion. • Vasectomized partner (vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FOCBP trial patient and that the vasectomized partner has received medical assessment of the surgical success). • Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient).
- 9(ii). Male patients must agree to remain abstinent from heterosexual sex during treatment and for 90 days after treatment or, if sexually active, to use two effective methods of birth control (e.g., male uses a condom and female uses contraception) during and for 90 days after treatment. Acceptable male contraception is as follows: • Condom (male). • Abstinence from heterosexual intercourse. • Vasectomy. The agreement to remain abstinent or use two effective methods of birth control will be clearly defined in the informed consent; the patient or legally authorized representatives (e.g., parents, caregivers, or legal guardians) must sign this specific section.
- 2. Males and females aged ≥12 and <29 years old at the time of Screening(V1A) . Note: In Germany only male and female adults (18 to <29 years of age) will be enrolled
- 3. Diagnosed with T1D (according to the American Diabetes Association [ADA] classification) ≤6 months at the time of Screening (V1A).
- 4. Possess the HLA DR3-DQ2 haplotype (all patients will be tested; prior genetic testing results will not be accepted).
- 5. Fasting C-peptide ≥0.12 nmol/L (≥0.36 ng/mL) on at least one occasion prior to randomization
- 6. Possess detectable circulating GAD65 antibodies (lowest level of detection defined by the method used by the central laboratory)
- 7. Possess HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization
- 8. Be on a stable insulin basal dose for one month prior to inclusion with limited fluctuation of daily basal insulin requirement based on investigator's assessment. For example, if the average basal insulin dose/kg/24h over a 7-day period compared to the previous 7day period does not vary more than approximately 20% and/or if the daily basal insulin dose does not vary more than 0.1 U/kg/24h, the dose can be considered stable. Individuals that are diagnosed with T1D according to the ADA classification but are not taking insulin are eligible to participate.
Exclusion criteria 29
- 1. Participation in any other trial aimed to influence beta cell function from time of diagnosis of T1D
- 10. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first trial dose of trial drug; or planned treatment with any vaccine up to 4 weeks after the last injection with trial drug
- 11. Any acute or chronic skin infection or condition that would preclude Intralymphatic injection
- 12. Recent (past 12 months) or current treatment with Teplizumab TZIELD® or immunosuppressant therapy, including chronic use of systemic glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral, intra-articular injections or injections of steroids will be permitted during the trial
- 13. Continuous/chronic treatment with prescribed or over-the-counter anti-inflammatory therapies. Short-term use (e.g., <7 days) is permissible, for example to treat a headache or in connection with a fever
- 14. Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization
- 15. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- 16. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with previous hepatitis C infection that is now cured may be eligible
- 17. Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation, neurological (including Batten disease), significant diabetes complication, any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion
- 18. History of significant hepatic disease or Screening alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or aspartate aminotransferase (AST) 3 x ULN and/or total bilirubin >2 x ULN. Patients with documented Gilbert syndrome and total bilirubin level ≥2 x ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted
- 19. Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) for those >18 years old, and by the Schwartz equation for those 12 to 18 years old, <60 mL/min per 1.73 m or rapidly progressing renal disease
- 2. Treatment with any oral or non-insulin injectable anti-diabetic medication or other substance used with the intention to preserve beta cell function (e.g., Verapamil, GABA etc.) within 3 months prior to Randomization.
- 20. Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine [T4] levels if hypothyroid)
- 21. Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or ability to complete the trial.
- 3. History of maturity-onset diabetes of the young (MODY)
- 4. Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased beta cell capacity
- 5. Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization
- 6. Signs or symptoms suggesting very poorly controlled diabetes e.g.,ongoing weight loss, polyuria or polydipsia
- 7. Hematologic condition that would make HbA1c uninterpretable including: a) Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis. b) Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical trial requiring withdrawal of >400 mL of blood during the 8 weeks prior to the Screening (V1B) visit. c) Significant iron deficiency anemia. d) Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes
- 8. Treatment with marketed or over-the-counter Vitamin D at the time of Screening (V1C) and unwilling to abstain from such medication during the 120 days when the patient will be supplemented with the trial provided Vitamin D. A patient currently taking Vitamin D at the time of Screening (V1C) must be willing to switch to the trial-provided Vitamin D treatment and to administer it per the trial requirements
- 9. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g.,Alhydrogel)
- 22. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ
- 23. Patients with any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the trial, and/or evidence of poor compliance with medical instructions at Screening or showing non-compliance during the Run-In Period
- 24. A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria
- 25. Previous treatment with the active substance recombinant human GAD65 trial
- 26. Participation in a clinical trial involving administration of an investigational drug in the past 3 months or 5 half- lives (whichever is longer) prior to first dosing of trial drug or during the trial.
- 27. Females who are breastfeeding, pregnant or plan to become pregnant during the trial
- 28. Patients who in the opinion of the investigator will not be able to follow instructions and/or follow the trial procedures or patients that are unwilling or unable to comply with the provisions of this protocol
- 29. An employee or immediate family member of an employee of Diamyd Medical AB
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change from baseline to Month 15 in C-peptide AUC mean 0-120 min during a 2-hour MMTT
- Change from baseline to Month 15 in HbA1c
Secondary endpoints 15
- Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 15
- Number of episodes per patient of severe hypoglycemia between baseline and Month 15
- Number of episodes per patient of DKA between baseline and Month 15
- Incidence of treatment-emergent adverse events (TEAEs)
- Incidence of injection site reactions
- Physical examination findings
- Vital signs (blood pressure [BP], heart rate [HR], and temperature)
- Clinical laboratory results (chemistry, hematology, and urine)
- Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 15
- Proportion of patients with HbA1c <7 % (53 mmol/ mol) at Month 15
- Change from baseline to Month 15 in exogenous insulin requirements based on total number of units of insulin per kilogram body weight per day
- Change in number of hypoglycemic <3.0 mmol/L (<54 mg/dL) episodes per day [evaluated from CGM data] between baseline and Month 15
- Area Under the Curve for Change from Baseline to Month 15 in HbA1c.
- Change from baseline to Month 24 in C peptide area under the curve (AUC)mean 0-120 min during a 2 hour mixed meal tolerance test (MMTT)
- Change from baseline to Month 24 in hemoglobin A1c (HbA1c).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD221979 · Product
- Active substance
- Glutamate Decarboxylase 2, Human, Recombinant
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRALYMPHATIC USE
- Max daily dose
- 4 µg microgram(s)
- Max total dose
- 12 µg microgram(s)
- Max treatment duration
- 2 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- DIAMYD MEDICAL AB
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 1
PRD3532534 · Product
- Active substance
- Colecalciferol
- Substance synonyms
- CHOLECALCIFEROL, VITAMIN D 3, VITAMIN D3, COLECALCIPHEROL, CHOLECALCIFEROLUM
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2000 IU international unit(s)
- Max total dose
- 2000 IU international unit(s)
- Max treatment duration
- 120 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- 51903
- MA holder
- VIATRIS AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Diamyd Medical AB
- Sponsor organisation
- Diamyd Medical AB
- Address
- P. O. Box 7349
- City
- Stockholm
- Postcode
- 103 90
- Country
- Sweden
Scientific contact point
- Organisation
- Diamyd Medical AB
- Contact name
- Ulf Hannelius
Public contact point
- Organisation
- Diamyd Medical AB
- Contact name
- Ulf Hannelius
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Other, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8 |
| Precision Digital Health Inc. ORG-100048129
|
Irvine, United States | E-data capture |
| CareDx AB ORG-100051799
|
Stockholm, Sweden | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| Linkopings Universitet ORG-100028963
|
Linkoping, Sweden | Other |
| Selvita Services Sp. z o.o. ORG-100032098
|
Cracow, Poland | Other |
| Abbott GmbH ORG-100000219
|
Wiesbaden, Germany | Other |
Locations
8 EU/EEA countries · 46 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 28 | 4 |
| Estonia | Ended | 18 | 4 |
| Germany | Ended | 18 | 4 |
| Hungary | Ended | 22 | 5 |
| Netherlands | Ended | 22 | 5 |
| Poland | Ended | 60 | 8 |
| Spain | Ended | 88 | 12 |
| Sweden | Ended | 24 | 4 |
| Rest of world
United States
|
— | 50 | — |
Investigational sites
Nemocnice Jihlava prispevkova organizace
PED – Pediatrické oddělení, Vrchlickeho 4630/59, 586 01, Jihlava 1
Fakultni Nemocnice V Motole
Pediatrická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Krajska zdravotni a.s.
Dětská klinika FZS UJEP, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Institute For Clinical And Experimental Medicine
Centrum diabetologie, Videnska 1958/9 Krc, 140 00, Prague
Liina Viitas OÜ
Endocrinology Unit, Veetorni 2-1, 80018, Paernu
North Estonia Medical Centre Foundation
Department of Internal Medicine III, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Tartu University Hospital
Children's Clinic, L. Puusepa Tn 1a, 50406, Tartu Linn
Tartu University Hospital
Department of Internal Medicine, L. Puusepa Tn 1a, 50406, Tartu Linn
DZDM - Diabetes Zentrum Duisburg Mitte
ZDM - Diabetes Zentrum Duisburg Mitte, Heuserstr. 2, 47051, Duisburg
Diabetespraxis Dr. Braun
Studienzentrum, Breite Strasse 41, 13187, Berlin
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Fachärzte für Innere Medizin, Kampstrasse 45, Mitte, Dortmund
Universitaetsklinikum Giessen und Marburg GmbH
Klinische Forschungseinheit, Zentrum für Innere Medizin, Med. Klinik und Poliklinik, Klinikstrasse 33, 35392, Giessen
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Gyermekosztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Diabetológiai Szakrendelés, Markusovszky Str. 5, 9700, Szombathely
Heim Pal Orszagos Gyermekgyogyaszati Intezet
Diabetológia, Ulloi Ut 86, Kerulet, Budapest VIII
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Eszak-Budai Szent Janos Centrumkorhaz
II. Belgyógyászat, Kutvolgyi Ut 4, 1125, Budapest XII
Stichting Amsterdam UMC
Vascular Medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Diabeter Nederland B.V.
Diabeter Rotterdam, Blaak 6, 3011 TA, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
Internal Medicine, Albinusdreef 2, 2333 ZA, Leiden
Treant Ziekenhuiszorg Stichting
Bethesda Diabetes Research Center (BDRC), Dr. G.H. Amshoffweg 1, 7909 AA, Hoogeveen
Albert Schweitzer Ziekenhuis
Diabatescentrum voor volwassenen (Diabetes center for adults), Langeweg 336, 3331 LZ, Zwijndrecht
NZOZ Przychodnia Specjalistyczna Medica
N/A, ul. Jutrzenki 4, 20-538, Lublin
Instytut Diabetologii Sp. z o.o.
N/D, Ul. Raclawicka 129/2u, 02-117, Warsaw
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdzialem Kardiologii, Ul. Jerzego Waszyngtona 17, 15-274, Bialystok
Uniwersyteckie Centrum Kliniczne
Klinika Pediatrii, Diabetologii i Endokrynologii, Ul. Debinki 7, 80-952, Gdansk
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej, Ul. Lwowska 60, 35-301, Rzeszow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Diabetologii, Chorob Wewnetrzny ch i Metabolicznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorób Wewnętrznych, Endokrynologii i Diabetologii, Ul. Woloska 137, 02-507, Warsaw
Instytut Pomnik Centrum Zdrowia Dziecka
Oddział Diabetologii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Hospital Clinic De Barcelona
Endocrinology Department, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Diabetes and Metabolism Research Group, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Macarena
Endocrinology department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Sant Joan De Deu Barcelona Hospital
Servicio de Endocrinología, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Complejo Hospitalario Universitario Insular Materno Infantil
Servicio de Endocrinología y Nutrición, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitari De Girona Doctor Josep Trueta
Servei d'Endocrinologia i Nutrició, Avinguda De Franca S/n, 17007, Girona
Hospital General Universitario Gregorio Maranon
Endocrinology department, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital General Universitario De Valencia
Servicio de Endocrinología y Nutrición, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Ramon Y Cajal
Endocrinology department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Cruces
Pediatric Endocrinology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario La Paz
Endocrinology and nutrition department. Diabetes unit, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Regional De Malaga
Endocrinology department, Avenida De Carlos De Haya Sn, 29010, Malaga
Region Skane Skanes Universitetssjukhus
VO Barnmedicin, St. Johns, Fritz Bauers Gata 5, Malmo
Region Vaesterbotten
Barn- och Ungdomscentrum, Umea University, 901 85, Umea
Region Stockholm – SLSO
Akademiskt Specialistcentrum, Centrum för Diabetes, Solnavagen 1 E, S:t Matteus, Stockholm
Region Oestergoetland
Kronprinsessan Viktorias Barnsjukhus, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2022-12-09 | 2022-12-09 | 2026-01-14 | ||
| Estonia | 2023-02-06 | 2023-02-06 | 2026-01-14 | ||
| Germany | 2022-06-09 | 2022-06-09 | 2026-01-14 | ||
| Hungary | 2023-02-01 | 2023-02-01 | 2026-01-14 | ||
| Netherlands | 2022-09-02 | 2022-09-02 | 2026-01-14 | ||
| Poland | 2022-03-23 | 2022-03-23 | 2026-01-14 | ||
| Spain | 2022-03-21 | 2022-03-21 | 2026-01-14 | ||
| Sweden | 2022-03-17 | 2022-03-17 | 2026-01-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-55624
- Sponsor became aware
- 2024-10-29
- Date of breach
- 2024-09-17
- Submission date
- 2024-11-05
- Member states concerned
- Czechia, Estonia, Germany, Hungary, Spain, Sweden, Netherlands, Poland
- Categories
- Protocol
- Areas impacted
- Data reliability or robustness
- Benefit-risk balance changed
- No
- Description
- During a routine audit, Sponsor QA initially identified that two patients were assigned to the wrong strata because of a misunderstanding of the randomization process at the clinical site. Further investigation showed that a total of 29 patients were affected. The error in patient stratification does not affect the safety, well-being, or the rights of a clinical trial subject.
- Sponsor actions
- Retraining and clarification of the stratification parameters and process were provided to all sites.
The randomization process will be followed up continuously by monitors and data managers
| Organisation | City | Country | Type |
|---|---|---|---|
| Universitaetsklinikum Giessen und Marburg GmbH | Giessen | Germany | Clinical investigator |
| Institute For Clinical And Experimental Medicine | Prague | Czechia | Clinical investigator |
| Instytut Diabetologii Sp. z o.o. | Warsaw | Poland | Clinical investigator |
| Hospital Universitari Vall D Hebron | Barcelona | Spain | Clinical investigator |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Clinical investigator |
| Region Stockholm – SLSO | Stockholm | Sweden | Clinical investigator |
| Krajska zdravotni a.s. | Usti Nad Labem | Czechia | Clinical investigator |
| Diabeter Nederland B.V. | Rotterdam | Netherlands | Clinical investigator |
| Diabetespraxis Dr. Braun | Berlin | Germany | Clinical investigator |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Clinical investigator |
| Hospital Universitario Ramon Y Cajal | Madrid | Spain | Clinical investigator |
Temporary halts 8 · Art. 38 CTR
Temporary halt TH-127952
- Halt date
- 2026-03-30
- Member states concerned
- Estonia
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127951
- Halt date
- 2026-03-30
- Member states concerned
- Czechia
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127954
- Halt date
- 2026-03-30
- Member states concerned
- Hungary
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127953
- Halt date
- 2026-03-30
- Member states concerned
- Germany
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127956
- Halt date
- 2026-03-30
- Member states concerned
- Sweden
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127955
- Halt date
- 2026-03-30
- Member states concerned
- Spain
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127958
- Halt date
- 2026-03-30
- Member states concerned
- Poland
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-127957
- Halt date
- 2026-03-30
- Member states concerned
- Netherlands
- Publication date
- 2026-04-09
- Reason
- Sponsor decision
- Explanation
- The temporary halt is based on results from the planned interim analysis, which indicate no observed treatment effect. These results are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes may be contributing to these findings. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including a comprehensive review of data collection, data management, and statistical analysis procedures. As a precautionary measure, the trial has been temporarily halted pending the outcome of this investigation.
There are no identified safety concerns. - Follow-up measures
- Participants currently enrolled have had treatment temporarily interrupted and are being followed according to safety monitoring procedures.
While investigational treatment has been paused, safety monitoring procedures, including sample collection, will continue to ensure adequate protection of the participants.
Diamyd Medical is also the sponsor of the prevention trial DiaPrecise (D/P2/22/8, 2024-513350-30-00) in individuals with Stage 1 and Stage 2 Type 1 Diabetes, using the same investigational medicinal product (IMP). The trial evaluates a different indication from the Stage 3 population studied in DIAGNODE-3, with primary objectives of safety and feasibility. The DSMB review of interim data from DIAGNODE-3 identified no safety concerns and confirmed a favourable safety profile.
The sponsor has determined that the DiaPrecise trial is not affected by the temporary halt and will continue as planned, as the benefit-risk balance remains favourable. This will be re-evaluated if new data emerge that may impact this assessment. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-127856
- Event date
- 2026-03-27
- Date aware
- 2026-03-27
- Submission date
- 2026-04-09
- Member states affected
- Czechia, Estonia, Germany, Hungary, Spain, Sweden, Netherlands, Poland
- Clinical procedures
- NA
- Event description
- The results from the planned interim analysis are not consistent with the expected data patterns and are currently not medically or scientifically interpretable.
A potential issue related to data integrity, data handling, or analysis processes could be the cause. At this stage, no conclusions can be drawn regarding the validity of the observed outcomes.
An in-depth investigation has been initiated to evaluate the root cause, including review of data collection, data management, and statistical analysis procedures.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 231 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513304-33_FP | 10.0 |
| Protocol (for publication) | D4_eDiary_cz_FP | N/A |
| Protocol (for publication) | D4_eDiary_de_FP | N/A |
| Protocol (for publication) | D4_eDiary_ee_FP | N/A |
| Protocol (for publication) | D4_eDiary_en_FP | N/A |
| Protocol (for publication) | D4_eDiary_es_FP | N/A |
| Protocol (for publication) | D4_eDiary_hu_FP | N/A |
| Protocol (for publication) | D4_eDiary_nl_FP | N/A |
| Protocol (for publication) | D4_eDiary_pl_FP | N/A |
| Protocol (for publication) | D4_eDiary_ruEE_FP | N/A |
| Protocol (for publication) | D4_eDiary_sv_08Jun2022_FP | N/A |
| Protocol (for publication) | D4_eDiary_sv_12Aug2021_FP | N/A |
| Protocol (for publication) | D4_Patient material memo_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit arrang_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit Arrang_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF_process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure_FP | N/A |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet 18-29 y_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Advocacy Fact Sheet_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Appreciation items_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Appreciation Items_FP | N/A |
| Recruitment arrangements (for publication) | K2_Appreciation items_FP | 1 |
| Recruitment arrangements (for publication) | K2_Appreciation Items_FP | N/A |
| Recruitment arrangements (for publication) | K2_Appreciation Items_FP | 1 |
| Recruitment arrangements (for publication) | K2_Appreciation items_FP | N/A |
| Recruitment arrangements (for publication) | K2_Appreciation items_FP | 1 |
| Recruitment arrangements (for publication) | K2_Appreciation items_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_D3 Poster_est_FP | 1 |
| Recruitment arrangements (for publication) | K2_D3 Poster_FP | 1 |
| Recruitment arrangements (for publication) | K2_D3 Poster_rus_FP | 1 |
| Recruitment arrangements (for publication) | K2_D3 roll-up_FP | 1 |
| Recruitment arrangements (for publication) | K2_eDiary_Participant letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_End of Study letter_est_FP | 1 |
| Recruitment arrangements (for publication) | K2_End of Study Letter_FP | 1 |
| Recruitment arrangements (for publication) | K2_End of Study letter_FP | 1 |
| Recruitment arrangements (for publication) | K2_End of Study Letter_FP | N/A |
| Recruitment arrangements (for publication) | K2_End of Study Letter_FP | N/A |
| Recruitment arrangements (for publication) | K2_End of Study letter_FP | N/A |
| Recruitment arrangements (for publication) | K2_End of Study letter_FP | 1 |
| Recruitment arrangements (for publication) | K2_End of Study letter_rus_FP | 1 |
| Recruitment arrangements (for publication) | K2_ICF Flip book _FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flip book_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flip book_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook 18-29 y_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_ICF Flipbook_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Link2Trials Social Media Recruitment Tools_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Link2Trials Social Media Recruitment Tools_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Link2Trials Social Media Recruitment Tools_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Link2Trials social media recruitment tools_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Link2Trials_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_MASTER_Diamyd Patient Recruitment Materials_est_FP | 5.0 |
| Recruitment arrangements (for publication) | K2_MASTER_Diamyd Patient Recruitment Materials_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_MASTER_Diamyd Patient Recruitment Materials_FP | 4.0 |
| Recruitment arrangements (for publication) | K2_MASTER_Diamyd Patient Recruitment Materials_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_MASTER_Diamyd Patient Recruitment Materials_rus_FP | 5.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB Page A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB Page B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB page for Poland - version A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB page for Poland - version B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_A_ FP | 2.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_A_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_A_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_B_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_B_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_B_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB Page_version A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_version A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB Page_Version B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for Website or FB Page_version B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One pager for website or FB page_version B_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_One Pager for wWebsite or FB Page_Version A_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Card_eng_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Card_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Card_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter 18-29 y_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Patient Letter_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Materials_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Materials_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Materials_FP | 5.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Materials_FP | 4.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_FP | N/A |
| Recruitment arrangements (for publication) | K2_Poster_FP | N/A |
| Recruitment arrangements (for publication) | K2_Poster_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment and Informed Consent Procedure_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure 18-29 y_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_rus_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Poster patients_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Poster Roll-Up_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Poster roll-up_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Poster_Patients_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment text_FP | 01 |
| Recruitment arrangements (for publication) | K2_Roll-Up_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Roll-up_FP | N/A |
| Recruitment arrangements (for publication) | K2_Roll-up_FP | N/A |
| Recruitment arrangements (for publication) | K2_Roll-up_FP | 4 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_est_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_rus_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Assent 12-AoM_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Genetic Assent 12-AoM_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Genetic Main_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Genetic Parent_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main Adult_FP | 6 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Parent_FP | 6 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-14y Assent_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-14y Genetic Assent_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM Main Assent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Assent_en_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Assent_et_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Assent_ru_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Genetic Assent_en_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Genetic Assent_et_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_12-AOM_Genetic Assent_ru_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_15-17y Assent_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_15-17y Genetic Assent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult Genetic_de_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult Main_de_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_clean_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_en_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_enrolled_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_et_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_FP | 7 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult_ru_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_AOM Genetic Assent_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_AOM Master Assent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 12-14yrs_clean_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 12-14yrs_enrolled_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 15-17yrs_clean_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 15-17yrs_enrolled_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR Adult_clean_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR Adult_enrolled_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR Parent_clean_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR Parent_enrolled_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic 12-AOM_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_clean_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_en_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_enrolled_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_et_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Adult_ru_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Assent 12-14yrs_clean_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Assent 12-14yrs_enrolled_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Assent 12-AOM_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Assent 15-17yrs_clean_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Assent 15-17yrs_enrolled_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_clean_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_en_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_enrolled_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_et_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic Parent_ru_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Genetic_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Adult_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_en_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Master Adult_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Master Parent_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_clean_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_en_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_enrolled_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_et_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_ru_FP | 8.1 |
| Subject information and informed consent form (for publication) | L1_Translation Certificate ICF-1_FP | N/A |
| Subject information and informed consent form (for publication) | L1_Translation Certificate ICF-2_FP | N/A |
| Subject information and informed consent form (for publication) | L2_eDiary_Participant letter_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_eDiary_Participant letter_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card CoT_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Participation Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_translation Certificate_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_cz_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_en_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_es_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_hu_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_nl_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_pl_2024-513304-33-00_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_scientific_CZ_cz_2024-513304-33-00_FP | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SE_sv_2024-513304-33-00_FP | 3.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Sweden | Acceptable with conditions 2024-07-11
|
2024-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-28 | Sweden | Acceptable 2024-11-15
|
2024-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-06 | Acceptable | 2025-03-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-25 | Sweden | Acceptable 2025-07-21
|
2025-07-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-23 | Sweden | Acceptable 2026-02-03
|
2026-02-03 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-07 | Sweden | Acceptable 2026-02-03
|
2026-04-07 |