Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
155
Countries
11
Sites
48
Diabetes Mellitus, Type 1
To demonstrate superiority of baricitinib versus placebo in delay of Stage 3 type 1 diabetes in persons at risk for type 1 diabetes.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 20 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521797-34-00
- WHO UTN
- U1111-1322-4573
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Pharmacogenetic, Safety, Pharmacokinetic, Diagnosis
To demonstrate superiority of baricitinib versus placebo in delay of Stage 3 type 1 diabetes in persons at risk for type 1 diabetes.
Conditions and MedDRA coding
Diabetes Mellitus, Type 1
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-001220-PIP01-11
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have at least two diabetes-related autoantibodies in their history, AND have two diabetes-related autoantibodies at screening or prescreening
- Be at risk for type 1 diabetes (have Stage 1b or Stage 2)
- Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion criteria 5
- Have diabetes (Stage 3)
- Have uncontrolled high blood pressure
- Have had a heart attack, heart disease, stroke, or heart failure
- Have a history or high risk of blood clots or certain types of cancer
- Have a current or recent serious infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [Time Frame: Baseline up to approximately 5 years]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with the same commercial drug substance (baricitinib) and unit formula as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with the same commercial drug substance (baricitinib) and unit formula as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Laboratory analysis |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Laboratory analysis |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | On site monitoring |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
11 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 19 | 5 |
| Finland | Authorised, recruitment pending | 8 | 3 |
| France | Not authorised | 10 | 9 |
| Germany | Ongoing, recruiting | 11 | 4 |
| Italy | Ongoing, recruiting | 14 | 10 |
| Netherlands | Authorised, recruitment pending | 1 | 1 |
| Norway | Ongoing, recruiting | 16 | 5 |
| Poland | Authorised, recruiting | 2 | 1 |
| Portugal | Authorised, recruiting | 2 | 5 |
| Spain | Authorised, recruiting | 2 | 3 |
| Sweden | Authorised, recruiting | 12 | 2 |
| Rest of world
Israel, United States, Japan, United Kingdom, Australia, Canada, Brazil
|
— | 58 | — |
Investigational sites
Cliniques Universitaries Saint Luc
Pediatric Endocrinology, Avenue Hippocrate 10, Brussels,, Bruxelles-Capitale
UZ Brussel
Pediatrics, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Endocrinology Diabetology Metabolism, Wilrijkstraat 10, Edegem, Antwerpen
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pediatrics, Place Louise Godin 15, 5000, Namur
Pohjois-Pohjanmaan hyvinvointialue
Department of Pediatrics, Kajaanintie 50, 90220, Oulu
Varsinais-Suomen hyvinvointialue
Pediatrics, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
Pediatric Early Phase Trials Unit, Elamanaukio 2, 33520, Tampere
Pitié Salpêtrière University Hospital
Service de Diabétologie, 83, Boulevard de l'Hôpital Paris, Paris
Robert Debre University Hospital
Centre d'Investigations Cliniques, 48 Boulevard Serurier, 75019, Paris
Hôpitaux Universitaires Paris Centre-Hôpital Cochin
Service de Diabétologie, 123 Boulevard de Port-Royal, Batiment Copernic,, Paris
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Pediatrie multidisciplinaire -Endocrinologie, 264 Rue Saint-Pierre, 15eme étage, Bouches-du-Rhône
CHU Rangueil
Diabétologie, maladies métaboliques et nutrition, 1, Avenue du Professeur Jean Poulhès, Toulous
Hopital Necker Enfants Malades
Centre d'Investigation Clinique, 149 Rue De Sevres, 75015, Paris
Hospices Civils de Lyon – Hôpital Louis Pradel
Centre d’Investigation Clinique, 28 Avenue du Doyen Jean Lépine, Bron,, Rhône
Centre Hospitalier Universitaire De Lille
Diabétologie Nutrition, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Sud Francilien
Endocrino diabétologie, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
Universitaetsklinikum Augsburg
Klinik fuer Kinder- und Jugendmedizin, Stenglinstrasse 2, Kriegshaber, Augsburg
TUM Klinikum
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universitaet Muenchen, Heidemannstraße 1, Bayern, München
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Klinik und Poliklinik fuer Kinder- und Jugendmedizin - Studienzentrum, Fetscherstrasse 74, Haus 21, Dresden
Hannoversche Kinderheilanstalt
Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes- und Endokrinologiezentrum, Janusz Korczak Avenue 12, Bult, Hanover
Azienda Ospedaliera Universitaria Meyer IRCCS
SOC Diabetologia ed Endocrinologia, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Pediatria, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department of Clinical Medicine and Surgery, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera di Padova
UOSD Diabetologia Pediatrica e Malattie Metaboliche dell'Età Evolutiva, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dept. of Medical and Surgical sciences, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
S.O.D. DIABETOLOGIA PEDIATRICA, Dipartimento Materno-Infantile, Via Filippo Corridoni 11, 60123, Ancona
Ospedale San Raffaele S.r.l.
UO Medicina Generale a indirizzo Diabetologico e Endocrino-Metabolico, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Integrata Verona
Pediatria B, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
SSD Diabetologia Pediatrica, Via Edward Jenner 18, 09121, Cagliari
Azienda Ospedaliera Universitaria Federico II Di Napoli
Diabetologia pediatrica, Via Sergio Pansini 5, 80131, Naples
Diabeter Nederland B.V.
Pediatrician-Diabetologist, Blaak 6, 3011 TA, Rotterdam
Oslo University Hospital HF
Unit for endocrinology and diabetes, Division for Paeditric and Adolescent Medicine, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Pediatric department, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Dept. Endocrinology, morbid obesity and preventive medicine, Trondheimsveien 235, 0586, Oslo
Helse Stavanger HF
Department of Research, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Akershus University Hospital
Dept. of Paediatric and Adolescent Medicine, Sykehusveien 25, 1474, Loerenskog
Unidade Local De Saude De Matosinhos E.P.E.
Endocrinology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Gaia/Espinho E.P.E.
Endocrinology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
CCAB Centro Clinico Academico Braga Associacao
Pediatric endocrinology and diabetology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude Do Alto Minho E.P.E.
Diabetology, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude De Santo Antonio E.P.E.
Pediatric, Largo Da Maternidade De Julio Dinis 45, 4050-651, Porto
Hospital Universitario Ramon Y Cajal
Endocrinología y Nutrición, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Sant Joan De Deu Barcelona
Endocrinología Pedíatrica, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario De Cruces
Endocrinología Pediátrica, Cruces Plaza S/n, 48903, Barakaldo
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 |
|---|---|---|---|---|---|
| Belgium | 2026-05-22 | ||||
| Germany | 2026-02-16 | 2026-05-05 | |||
| Italy | 2026-02-06 | 2026-04-08 | |||
| Norway | 2026-02-12 | 2026-04-10 | |||
| Poland | 2026-02-20 | ||||
| Portugal | 2026-02-19 | ||||
| Spain | 2026-01-20 | ||||
| Sweden | 2026-04-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 246 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521797-34-00 | a |
| Protocol (for publication) | D1_Protocol 2025-521797-34-00 Global Addendum 5_redacted | 1 |
| Protocol (for publication) | D1_Protocol 2025-521797-34-00_Redacted | c |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement_FI | 1 |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement_NO | 1 |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement_PT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement_SE | 1 |
| Recruitment arrangements (for publication) | K1_Informed consent and Patient Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean_FI | V4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean_NO | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_TC_FI | V4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC_NO | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment_SE | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment material Flyer_Master_NO | V3 |
| Recruitment arrangements (for publication) | K2_Brochure_Master_PT | 2 |
| Recruitment arrangements (for publication) | K2_Brochure-CYP_Master_PT | 2 |
| Recruitment arrangements (for publication) | K2_Brochure-Parents-Caregivers_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Certificate-Participation_Master_PT | 2 |
| Recruitment arrangements (for publication) | K2_Clinical Research Studies Brochure-Parents-Caregivers_swe | 1 |
| Recruitment arrangements (for publication) | K2_Clinical Trial Brochure-CYP_swe | 2 |
| Recruitment arrangements (for publication) | K2_Clinical Trial Phases_swe | 1 |
| Recruitment arrangements (for publication) | K2_Clinical-Trial-Phases_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Passport_Master_PT | 2 |
| Recruitment arrangements (for publication) | K2_Passport-Stickers_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material _CT_Clinical-Research-Studies-Brochure-Parents-Caregivers_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Clinical-Trial-Brochure-CYP_NO | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Clinical-Trial-Phases_NO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster_Master_NO | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Parents Caregivers_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_FRA | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_ES | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_ITA | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_NO | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_swe | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-Parents-Caregivers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Certificate-Participation | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Research Studies_Brochure_Parents Caregivers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Clinical Trial Brochure CYP_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Clinical Trial Brochure CYP_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Brochure CYP_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Brochure_CYP | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Brochure-CYP | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_Clinical-Trial-Brochure-CYP_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Clinical-Trial-Phases_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_BEDU | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_BEFR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_ES | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_ITA | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_swe | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Parent Caregiver Brochure_FRA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Passport | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Passport-Stickers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_BEDU | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_BEFR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_ES | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_ITA | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_swe | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Research Studies Brochure Parents Caregivers_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Research Studies Brochure Parents Caregivers_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_School-Note-Generic | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Participation | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit-Card | 2 |
| Recruitment arrangements (for publication) | K2_School-Note-Generic_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Thank-You-Dropout_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Thank-You-End-Of-Study_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Thank-You-Participation_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Thank-You-Retention_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Thank-You-Screening_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Visit-Card_Master_PT | 2 |
| Subject information and informed consent form (for publication) | L1_Assent Form_Older Child_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_Assent Form_Younger children | 1.2 |
| Subject information and informed consent form (for publication) | L1_Assent_12 to less than 16y_PT | 1.0 |
| Subject information and informed consent form (for publication) | L1_Assent_5 to 11y_PT | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Sponsor Statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_DXA Optional_PT | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_PT | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnancy_PT | 2 |
| Subject information and informed consent form (for publication) | L1_Pregnant partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Parent_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF__Main Parental ICF Appendix_TC_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_16-17 years Assent_TC_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_16-17 years ICF_clean_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Optional Genetic Research | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_DXA Optional Consent and Assents | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 12-14 yr_clean_FI | V3.0FIN5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 12-14 yr_TC_FI | V3.0FIN5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent Form_clean_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent Form_TC_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Consent 15-17 yr_clean_FI | V3.0FIN5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Consent 15-17 yr_TC_FI | V3.0FIN5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Child | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent for children from 6 to 11 years_swe | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_7-11 years | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Teenager | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11-17yo_FRA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11-17yo_FRA_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_7-11yo_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Older children | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Older children_TC | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Younger children | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent 6-11 yr_FI_clean | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent Form_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent Form_TC_NO | V3.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Consent Form_12-16 years | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA 16-17 yr ICF_clean_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA 16-17 yr ICF_TC_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Adolescent Assent 12-15 yr_clean_NO | V1.0NOR5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Adolescent Assent 12-15 yr_TC_NO | V1.0NOR5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Adolescent Consent 15-17 yr_clean_FI | V1.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Adolescent Consent 15-17 yr_TC_FI | V1.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Child Assent 6-14 yr_FI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Child Assent_NO | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Child Assent_TC_NO | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Form_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Form_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Form_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Notification to Guardians_clean_FI | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Parental_clean_FI | V1.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Parental_clean_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Parental_TC_FI | V1.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DXA Parental_TC_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Parent_clean_FI | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_clean_FI | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_clean_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_TC_FI | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_TC_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF for parents and guardians | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult Appendix_clean_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult ICF Appendix_TC_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_clean_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_clean_NO | V3.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_TC_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_TC_NO | V3.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adults | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adults_TC | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_FRA_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_FRA_tc | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Legal Rep_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_clean_NO | V3.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_TC_NO | V3.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental Appendix_clean_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_clean_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_TC_FI | V3.0FIN4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parents | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parents_TC | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Notification to Guardians_clean_FI | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent_BEDU | 3.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent_BEFR | 3.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent_ENG | 3.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_DXA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_DXA_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_JAJJ_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_JAJJ_TC_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Older Child Assent_JAJJ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Younger Child Assent | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner or Pregnant participant_swe | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FI_clean | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FI_TC | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NO | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_TC_NO | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research subject 15-17 years Information and consent form_swe | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and Assent for children from 12 to 14 years_swe | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form for adult participant_swe | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form for parents or legal guardian_swe | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_confidentiality sheet | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_IFU_BARICITINIB | 1 |
| Subject information and informed consent form (for publication) | L2_Certificate Participation_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Notice_Phase 3 and 4 Trials only_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Direction for Use_IFU_Baricitinib | 1 |
| Subject information and informed consent form (for publication) | L2_Instructions for Use_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure Parents Caregivers_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Brochure CYP_PL | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_swe_for publication | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU Baricitinib_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instruction for use_swe | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Guide Dexcom G7_swe | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment brochure_PL | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment flyer_PL | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment poster_PL | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant Guide Dexcom G7 Receiver_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Passport_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Passport-Stickers_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Patient contact card template | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Guide | 3 |
| Subject information and informed consent form (for publication) | L2_Retention material_Visit-Card | 1 |
| Subject information and informed consent form (for publication) | L2_Study-Guide_Master_PT | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You End Of Study_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You Participation_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You Retention_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Thank You Screening_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Dropout_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Visit card_swe | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1 |
| Subject information and informed consent form (for publication) | L3_Subject Instructions for Use_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L4_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L5_Informed consent and patient recruitment procedure_PL | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Olumiant | N/A |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PRT_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis two pages SE_2025-521797-34-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2025-521797-34-00_Track Changes | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FI_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRA_2025-521797-34-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ITA_2025-521797-34-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_EU CT 2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NO_2025-521797-34-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol_Abbreviated Synopsis_IT | c |
| Synopsis of the protocol (for publication) | D1_Protocol_Abbreviated Synopsis_IT_TC | c |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2025-521797-34-00_PL TC | c |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_PL_2025-521797-34-00 | c |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-28 | Italy | Acceptable with conditions 2025-12-22
|
2025-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-05 | Italy | Acceptable 2026-04-17
|
2026-04-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-20 | Acceptable 2026-04-17
|
2026-05-20 |