Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
119
Countries
16
Sites
50
Acromegaly
To assess the maintenance of Insulin-like growth factor 1 (IGF-1) ≤1x Upper limit of normal (ULN) in the double-blind period (Period 1) with Debio 4126 (Arm A) compared to placebo (Arm B) at W36
Key facts
- Sponsor
- Debiopharm International S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 23 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516616-24-00
- WHO UTN
- U1111-1310-8427
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To assess the maintenance of Insulin-like growth factor 1 (IGF-1) ≤1x Upper limit of normal (ULN) in the double-blind period (Period 1) with Debio 4126 (Arm A) compared to placebo (Arm B) at W36
Secondary objectives 8
- To assess the maintenance of IGF-1 ≤1x ULN in Arm C at W36
- To assess IGF-1 levels over time in Arms A, B, and C
- To assess Growth hormone (GH) levels over time in Arms A, B, and C
- To evaluate the safety profile of Debio 4126 (Arm A) compared to placebo (Arm B), up to W36
- To evaluate the long-term safety profile of Debio 4126 in Arms A, B, and C
- To evaluate the local tolerability profile of Debio 4126 in Arms A, B, and C
- To assess the use of rescue medication in Arm A compared to Arm B
- To assess the Pharmacokinetics (PK) of Debio 4126
Conditions and MedDRA coding
Acromegaly
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10000599 | Acromegaly | 100000004860 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients ≥18 years of age
- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- IGF-1 at screening ≤1x ULN
- Acromegaly diagnosis, defined as per protocol
- Adequate bone marrow, hepatic and renal function
- To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at W34, or up to W48 when treated with rescue medication
- Other protocol-defined criteria apply
Exclusion criteria 11
- Compression of optic chiasm causing visual defects
- Symptomatic cholelithiasis or bile duct dilatation
- Planned cholecystectomy during the trial duration
- Acute or chronic pancreatitis
- Pituitary radiotherapy
- Uncontrolled hypothyroidism
- Uncontrolled diabetes
- Pituitary surgery within 6 months before screening or planned on trial
- Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamin agonists within 3 months prior to screening
- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
- Other protocol-defined criteria apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of participants with IGF-1 ≤1x ULN at W36, where IGF-1 will be based on the average of 2 samples acquired at W34 and W36. If this average IGF-1 is ≤1x ULN, a participant is classified as a responder
Secondary endpoints 18
- Percentage of Participants With IGF-1 ≤1x ULN at W36, in Arm C
- Change From Baseline in IGF-1 Values
- Percent Change From Baseline in IGF-1 Values
- Percentage of Participants With IGF-1 ≤1x ULN
- Percentage of Participants With GH Level <1 ng/mL
- Change From Baseline in GH Values
- Mean Logarithm With Base 10 (Log10) Change From Baseline in GH Values
- Percentage of Participants With GH Value per Category (<1; ≥1 and <2.5; ≥2.5 (ng/mL)
- Number of Participants With at Least one Treatment-Emergent Adverse Event (TEAE), in Arms A and B, up to W36
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Electrocardiogram (ECG), and Pituitary Tumor Size, in Arms A and B, up to W36
- Number of Participants With at Least one TEAE in Arms A, B and C
- Time-at-Risk Exposure-Adjusted Incidence Rate for TEAEs
- Total Participant-Years at-Risk for TEAEs
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, ECG, and Pituitary Tumor Size in Arms A, B and C
- Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
- Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
- Percentage of Participants Taking Rescue Medication
- PK parameters of Debio 4126, including but not limited to octreotide concentration at the end of the 12-week Treatment Interval (Ctrough)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD11754571 · Product
- Active substance
- Octreotide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- H01CB02 — OCTREOTIDE
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD11754592 · Product
- Active substance
- Octreotide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- H01CB02 — OCTREOTIDE
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD11754590 · Product
- Active substance
- Octreotide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- H01CB02 — OCTREOTIDE
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Ready-to-use suspension resembling 30, 60, or 90 mg Debio 4126 doses
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 6
SUB08402MIG · Substance
- Active substance
- Lanreotide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 660 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
SUB08402MIG · Substance
- Active substance
- Lanreotide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 1320 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
SUB08402MIG · Substance
- Active substance
- Lanreotide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 990 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
SUB09417MIG · Substance
- Active substance
- Octreotide
- Pharmaceutical form
- POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 220 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
SUB09417MIG · Substance
- Active substance
- Octreotide
- Pharmaceutical form
- POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 110 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
SUB09417MIG · Substance
- Active substance
- Octreotide
- Pharmaceutical form
- POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 330 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product may be centrally sourced by the sponsor. Centrally sourced AxMP will be relabelled to comply with language requirements
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Debiopharm International S.A.
- Sponsor organisation
- Debiopharm International S.A.
- Address
- Forum Apres-Demain, Chemin Messidor 5-7 Chemin Messidor 5-7
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A.
Public contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A.
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Pharma Bio-Research Group ORG-100006268
|
Assen, Netherlands | Laboratory analysis |
| Drug Development Solutions Limited ORG-100045894
|
Ely, United Kingdom | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Allucent (UK) Limited ORG-100008801
|
Bracknell, United Kingdom | On site monitoring, Code 12, Code 13, Code 2, Code 5 |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Code 10, Data management |
| Calvagone ORG-100043629
|
Chazay-D'Azergues, France | Other |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Interactive response technologies (IRT) |
| Ludwig-Maximilians-Universitaet Muenchen ORG-100028102
|
Munich, Germany | Laboratory analysis |
| A4p Consulting Limited ORG-100053275
|
Sandwich, United Kingdom | Other |
| SGS Belgium ORG-100007917
|
Antwerp, Belgium | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
16 EU/EEA countries · 50 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 4 | 2 |
| Belgium | Authorised, recruiting | 2 | 1 |
| Bulgaria | Ongoing, recruiting | 2 | 1 |
| Denmark | Ongoing, recruiting | 4 | 2 |
| Estonia | Authorised, recruiting | 6 | 2 |
| France | Ongoing, recruiting | 12 | 6 |
| Germany | Ongoing, recruiting | 6 | 3 |
| Hungary | Ongoing, recruiting | 6 | 3 |
| Italy | Ongoing, recruiting | 16 | 9 |
| Latvia | Ongoing, recruiting | 2 | 1 |
| Lithuania | Ongoing, recruiting | 4 | 2 |
| Poland | Ongoing, recruiting | 10 | 5 |
| Romania | Ongoing, recruiting | 6 | 3 |
| Slovakia | Ongoing, recruiting | 2 | 1 |
| Spain | Ongoing, recruiting | 14 | 7 |
| Sweden | Ongoing, recruiting | 4 | 2 |
| Rest of world
Serbia, United Kingdom, United States, Brazil, Israel
|
— | 19 | — |
Investigational sites
Medical University Of Vienna
Department of Medicine III (Division of Endocrinology and Metabolism), Spitalgasse 23, Alsergrund, Vienna
Medical University Of Graz
Division of Endocrinology and Diabetology, Neue Stiftingtalstrasse 6, 8010, Graz
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
First Clinic of Endocrinology and Metabolic Diseases, Ulitsa Zdrave 2, 1431, Sofia
Kobenhavns Universitet
Department of Nephrology and Endocrinology, Blegdamsvej 3a, 2200, Copenhagen N
Region Sjaelland
Clinic for Pituitary Disorders, Department of Medicine, Lykkebaekvej 1, 4600, Koege
North Estonia Medical Centre Foundation
Endocrinology, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
East Tallinn Central Hospital
Endocrinology, Ravi Tn 18, Kesklinna Linnaosa, Tallinn
Centre Hospitalier Universitaire De Toulouse
Endocrinology, Diabetology and Metabolic disease, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Regional De Marseille
Endocrinology, 147 Boulevard Baille, 13005, Marseille
Hospices Civils De Lyon
Endocrinology, Diabetology and Metabolic disease "A", 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire D'Angers
Endocrinology, Diabetology and Nutrition, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Bordeaux
Endocrinology, Diabetology and Nutrition, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
Endocrinology and Reproductive diseases, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Universitaetsklinikum Wuerzburg AöR
Endocrinology and diabetes, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Charite Universitaetsmedizin Berlin KöR
Endocrinology, Chariteplatz 1, Mitte, Berlin
Ludwig-Maximilians-Universitaet Muenchen
Medical Clinic and Polyclinic IV, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Central Hospital Of Northern Pest Military Hospital
Division of Endocrinology, Podmaniczky Utca 109, 1062, Budapest VI
University Of Szeged
Department of Internal Medicine, Kalvaria Sugarut 57, 6725, Szeged
Semmelweis University
Department of Internal Medicine and Oncology, Endocronology, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
ASST Grande Ospedale Metropolitano Niguarda
Complex Structure of Endocrinology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Complex Operative Unit Endocrinology and Diabetology, Largo Francesco Vito 1, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Department of Internal Medicine, Endocrinology Unit, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Endocrinology, Via Francesco Sforza 28, 20122, Milan
University Hospital Of Ferrara
Section of Endocrinology and Metabolic Diseases, Via Aldo Moro 8, 44124, Ferrara
Azienda Ospedaliera di Padova
Complex Operative Unit Clinica Medica 3, Via Nicolo' Giustiniani 2, 35128, Padova
Ospedale San Raffaele S.r.l.
Operative Unit of Endocrinology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Division of Endocrinology, Diabetology and Metabolism, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Universitaria Federico II Di Napoli
Complex Unit of Endocrinology and Metabolic Diseases, Via Sergio Pansini 5, 80131, Naples
Vaidotas Urbanavicius Sole Proprietor Enterprise
Endocrinology, Zirmunu str. 67A, Lithuania, Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Endocrinology department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Nuclear Medicine and Endocrine Oncology, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Centrum Medyczne Intercor Sp. z o.o.
Specialist clinics, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Endocrinology and internal medicine, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Endocrinology, Oncological Endocrinology, Nuclear Medicine, and Internal Diseases, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Uniwersytecki Szpital Kliniczny W Poznaniu
Endocrinology, Metabolism and Internal Diseases, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Delta Health Care S.R.L.
NA, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Endocrinology Department, Strada Pasteur Louis 3-5, 400349, Cluj-Napoca
National Institute Of Endocrinology C.I. Parhon
Endocrinology II, Bulevardul Aviatorilor 34-38, 011863, Bucharest
Narodny Endokrinologicky A Diabetologicky Ustav
Department of Endocrinology, Kollarova 282/3, 034 91, Lubochna
Hospital De La Santa Creu I Sant Pau
Endocrinology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Complexo Hospitalario Universitario De Santiago
Endocrinology and Nutrition, Calle Choupana Da S/n, 15706, Santiago De Compostela
University Hospital Virgen Del Rocio S.L.
Endocrinology and Nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Germans Trias I Pujol
Endocrinology and Nutrition, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitari Vall D Hebron
Endocrinology and Nutrition, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De La Ribera
Endocrinology and Nutrition, Carretera Corbera Km 1, 46600, Alzira
Hospital Universitario Ramon Y Cajal
Endocrinology and Nutrition, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 |
|---|---|---|---|---|---|
| Austria | 2025-09-09 | 2025-10-29 | |||
| Belgium | 2025-08-22 | ||||
| Bulgaria | 2025-11-12 | 2026-02-27 | |||
| Denmark | 2025-09-30 | 2025-10-28 | |||
| Estonia | 2025-07-30 | ||||
| France | 2025-09-16 | 2025-10-27 | |||
| Germany | 2025-09-16 | 2025-10-30 | |||
| Hungary | 2025-09-23 | 2025-11-25 | |||
| Italy | 2025-09-04 | 2025-12-10 | |||
| Latvia | 2025-07-25 | 2025-10-13 | |||
| Lithuania | 2025-09-12 | 2026-02-12 | |||
| Poland | 2025-08-14 | 2026-04-08 | |||
| Romania | 2025-07-30 | 2025-11-04 | |||
| Slovakia | 2025-07-23 | 2025-10-01 | |||
| Spain | 2025-08-08 | 2025-11-25 | |||
| Sweden | 2025-11-11 | 2026-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 197 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516616-24_For publication | 3.0 |
| Protocol (for publication) | D3_Placebo justification letter_2024-516616-24-00 | NA |
| Protocol (for publication) | D4_ Patient facing document AT-DE VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document BE-FR VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document BE-NL VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document BG-BG VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document DE-DE VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document DK-DK VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document EE-EE VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document EE-RU VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document EN VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document ES-ES VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document FR-FR VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document HU-HU VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document IT-IT VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document LT-LT VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document LV-LV VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document LV-RU VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document PL-PL VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document RO_RO VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document SE-SE VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_ Patient facing document SK-SK VAS Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient Facing document AcroQol_Placeholder | NA |
| Recruitment arrangements (for publication) | K1_AT_Recruitment arrangements_For publication | NA |
| Recruitment arrangements (for publication) | K1_BE_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_BG-BG_Recruitment arrangements_For publication | NA |
| Recruitment arrangements (for publication) | K1_DE_Recruitment arrangements_For publication | NA |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_FR_Recruitment arrangements_For publication | NA |
| Recruitment arrangements (for publication) | K1_IT_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_LT_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_SK_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K2_AT_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_AT_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_BE-FR_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_BE-FR_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_BE-NL_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_BE-NL_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_ES_ES_Recruitment material_Brochure_for publication | 1 |
| Recruitment arrangements (for publication) | K2_ES_ES_Recruitment material_Flyer_for publication | 1 |
| Recruitment arrangements (for publication) | K2_EST_EE_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_EST_EE_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_FR_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_HU_Recrutiment material GP Letter_For publication | 1 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_IT_Recruitment material_Flyer_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_LT_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_LT_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_LV-LV_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_LV-LV_Recruitment material_Flyer_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Flyer | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Scout Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BG-BG_clean_ART_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BG-BG_clean_ART_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Brochure_For publication | 1 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment Material_Flyer_For publication | 1 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment material_Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_SK_Recruitment material_Flyer_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF_Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF_PP_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS and ICF_Main_Sponsor-statement_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS and ICF_Pregnant Participant_Sponsor statement_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-EN_SIS and ICF_Main_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-EN_SIS and ICF_Pregnant Participant ICF_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-FR_SIS and ICF_Main_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-FR_SIS and ICF_Pregnant Participant ICF_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-NL_SIS and ICF_Main_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE-NL_SIS and ICF_Pregnant Participant ICF_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG-BG_PIS and ICF Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BG-BG_SIS and ICF Pregnant Participant_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG-EN_PIS and ICF Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BG-EN_PIS and ICF Main_Master_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_BG-EN_SIS and ICF Pregnant Participant_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG-EN_SIS and ICF Pregnant Participant_Master_For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF_PP_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_ES_ES_SIS and ICF_Main_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_ES_SIS and ICF_Pregnant Participant_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_EST_EE _ ICF_Pregnant Participant ICF_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_EST_EE_ ICF_Main_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_EST_RU_ ICF_Main_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_EST_RU_ ICF_Pregnant Participant ICF_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS and ICF_Pregnant Participant_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS and ICF Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS and ICF Pregnant _For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS and ICF Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS and ICF_Pregnant Participant_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_LT_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_LT_SIS and ICF_Pregnant Participant ICF_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_LV_LV_SIS and ICF_Pregnant Participant_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_LV_RU_SIS and ICF_Pregnant Participant_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_LV-LV_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_LV-RU_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS and ICF_Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS and ICF_Pregnant participant_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS and ICF_Main_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS and ICF_Pregnant Participant_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SK_SIS and ICF_GDPR_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS and ICF_Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS and ICF_Pregnant Participant_Sponsor statement_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_AT_List of Site ICF contacts_for publication | NA |
| Subject information and informed consent form (for publication) | L2_AT_Other subject information material_Scout Study brochure | 1.0 |
| Subject information and informed consent form (for publication) | L2_AT_Other subject information material_ScoutPass brochure | 1.0 |
| Subject information and informed consent form (for publication) | L2_BE-EN_Other subject information material_Email communication_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-EN_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-EN_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-EN_Other subject information material_Study guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-FR_Other subject information material_Email communication_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-FR_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-FR_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-FR_Other subject information material_Study guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-NL_Other subject information material_Email communication_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-NL_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-NL_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BE-NL_Other subject information material_Study guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BG-BG_Other subject information material_ Scout Study Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_BG-BG_Other subject information material_Study Guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information material_Scout Study brochure | 1 |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information material_ScoutPass brochure | 1 |
| Subject information and informed consent form (for publication) | L2_ES_ES_Other subject information material_Scout Study Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_ES_ES_Other subject information material_ScoutPass Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_EST_EE_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_EST_EE_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_Other subject information material_Scout email_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_Other subject information material_Scout form_For publication | 4 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_Patient Card_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_Scout Email Comm_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_Scout Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_Scout Study Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_ScoutPass Mailer_For publication | NA |
| Subject information and informed consent form (for publication) | L2_HU_Other subject information material_Study Guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LT_ Other subject information material_Subject ID card_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Email communication_For publication | 0.1 |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Reloadable ScoutPass Mailer_For publication | NA |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Study guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LT_Other subject information material_Visit by visit guide_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_Oher subject information material_GP Letter_ For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_Other subject information material_ Subject ID card_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_Other subject information material_ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_Other subject information material_Study Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_S1299_SC_PFD_Email Comm_For publication | 0.1 |
| Subject information and informed consent form (for publication) | L2_LV-LV_SC_PFD_Reloadable ScoutPass Mailer_For publication | NA |
| Subject information and informed consent form (for publication) | L2_LV-RU_Other subject information material_ Subject ID card_ For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-RU_Other subject information material_ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-RU_Other subject information material_Study Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_LV-RU_S1299_SC_PFD_Email Comm_For publication | 0.1 |
| Subject information and informed consent form (for publication) | L2_LV-RU_SC_PFD_Reloadable ScoutPass Mailer_For publication | NA |
| Subject information and informed consent form (for publication) | L2_PL_Other subject information material_Scout brochure | 1 |
| Subject information and informed consent form (for publication) | L2_RO_Other Subject Information Material_Scout Study Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_SK_Other subject information material_Reloadable ScoutPass Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_SK_Other subject information material_Scout Brochure_For publication | 1 |
| Subject information and informed consent form (for publication) | L3_List of part II documents | NA |
| Subject information and informed consent form (for publication) | L3_LT_GP Letter | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT-DE_2024-516616-24_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR_2024-516616-24_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Layman synopsis_DK-DK_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Layman synopsis_FR-FR_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Layman synopsis_SE-SE_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_BE-DE_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_BE-FR_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_BE-NL_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_BG-BG_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_DE-DE_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_EE-EE_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_EN_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_ES-ES_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_FR-FR_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_HU-HU_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_IT-IT_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_LT-LT_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_PL-PL_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_RO-RO_2024-516616-24_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Short synopsis_SK-SK_2024-516616-24_For publication | 2.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-06 | Denmark | Acceptable 2025-06-30
|
2025-06-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-11 | Denmark | Acceptable 2025-06-30
|
2025-07-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-17 | Acceptable | 2025-08-04 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-17 | Acceptable | 2025-09-01 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-17 | Acceptable | 2025-09-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-24 | Acceptable | 2025-11-18 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-05 | Acceptable | 2025-12-22 |