Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
300
Countries
12
Sites
72
Diabetes Mellitus, Type 1
To demonstrate the superiority of baricitinib versus placebo in the preservation of β-cell function, as measured by C-peptide, in younger adult and pediatric participants with new-onset type 1 diabetes after 52 weeks of treatment.
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] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 3 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522170-36-00
- WHO UTN
- U1111-1327-6986
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy
To demonstrate the superiority of baricitinib versus placebo in the preservation of β-cell function, as measured by C-peptide, in younger adult and pediatric participants with new-onset type 1 diabetes after 52 weeks of treatment.
Conditions and MedDRA coding
Diabetes Mellitus, Type 1
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have a new diagnosis of type 1 diabetes
- Have at least one protein in the blood (called an autoantibody) that is associated with diabetes at screening
- Weigh at least 8 kilograms (18 pounds) at screening
Exclusion criteria 5
- Have any other type of diabetes
- 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 medical condition or infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in C-peptide Area Under the Curve (AUC) [Time Frame: Baseline, Week 52]
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
- 1456 mg milligram(s)
- Max treatment duration
- 52 Week(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
- 2 ml millilitre(s)
- Max total dose
- 728 ml millilitre(s)
- Max treatment duration
- 52 Week(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
- 1456 mg milligram(s)
- Max treatment duration
- 52 Week(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
- Maryna Kvochka
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Maryna Kvochka
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Connected Devices ORL-000016016
|
Durham, United States | Laboratory analysis |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Iqvia Biotech Limited ORG-100008726
|
Reading, United Kingdom | Code 2 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Iqvia Biotech Limited ORG-100008726
|
Reading, United Kingdom | On site monitoring |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
Locations
12 EU/EEA countries · 72 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 15 | 9 |
| Czechia | Ongoing, recruiting | 13 | 3 |
| Finland | Ongoing, recruiting | 4 | 4 |
| France | Authorised, recruitment pending | 18 | 9 |
| Germany | Ongoing, recruiting | 28 | 8 |
| Italy | Ongoing, recruiting | 14 | 10 |
| Netherlands | Authorised, recruitment pending | 2 | 1 |
| Norway | Ongoing, recruiting | 3 | 6 |
| Poland | Ongoing, recruiting | 27 | 4 |
| Portugal | Ongoing, recruiting | 16 | 4 |
| Spain | Ongoing, recruiting | 29 | 9 |
| Sweden | Authorised, recruiting | 14 | 5 |
| Rest of world
Canada, United Kingdom, Ukraine, Brazil, Australia, Israel, United States
|
— | 117 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Diabetes Nutrition and Metabolics disorders EUCTR Site Report View 1 (New) Study Sit, Avenue De L'Hopital 1, 4000, Liege
Hopital Erasme
Endocrinologie, Lennikse Baan 808, 1070, Anderlecht
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pédiatrie, Place Louise Godin 15, 5000, Namur
Universitair Ziekenhuis Antwerpen
Endocrinology-Diabetology-Metabolism, Drie Eikenstraat 655, 2650, Edegem
UZ Brussel
Pediatrics, Laarbeeklaan 101, 1090, Jette
Cliniques Universitaires Saint-Luc
Pediatric Endocrinology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Endocrinology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Endocrinologie, Corneel Heymanslaan 10, 9000, Gent
Nemocnice Jihlava prispevkova organizace
Pediatricke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Milan Kvapil s.r.o.
NA, Michnova 1622/4, Chodov, Prague
Fakultni Nemocnice Ostrava
Klinika detskeho lekarstvi, 17. Listopadu 1790/5, Poruba, Ostrava
HUS-yhtymae
New Children's Hospital, Stenbackinkatu 9, 00290, Helsinki
Oulu University Hospital
Department of Pediatrics, Kajaanintie 50, 90220, Oulu
Varsinais-Suomen hyvinvointialue
Pediatric Department, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
PeeTu, Elamanaukio 2, 33520, Tampere
Centre Hospitalier Universitaire de Grenoble
Service Endocrinologie Diabetologie Nutrition, Boulevard de la Chantourne, Isère, Isère
Centre Hospitalier Sud Francilien
Endocrino diabétologie, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
Centre Hospitalier Universitaire De Toulouse
Diabétologie, maladies métaboliques et nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Robert Debre University Hospital
Centre d'Investigations Cliniques, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire De Lille
Diabétologie Nutrition, Rue Michel Polonovski, 59037, Lille Cedex
Pitié Salpêtrière University Hospital
Service de Diabétologie, 83, Boulevard de l'Hôpital, Paris
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
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Pediatrie multidisciplinaire -Endocrinologie, 264 Rue Saint-Pierre, 15eme étage, Bouches-du-Rhône
Klinikum Karlsburg
Klinik für Diabetes und Stoffwechselerkrankungen, Greifswalder Strasse 11, Dept. Diabetology, Karlsburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universitaet München, Heidemannstrasse 1, Schwabing-Freimann, Munich
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Asklepios Klinik Sankt Augustin GmbH
Zentrum fuer Allgemeine Paediatrie und Neonatologie, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
N/A, August-Mohl-Strasse 37, 95030, Hof
Universitaetsklinikum Ulm AöR
Klinik für Kinder- und Jugendmedizin, Eythstrasse 24, Mitte, Ulm
Hannoversche Kinderheilanstalt
Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes- und Endokrinologiezentrum, Janusz Korczak Avenue 12, Bult, Hanover
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
N/A, Ludwigsplatz 9, First floor, Ludwigshafen am Rhein
Ospedale San Raffaele S.r.l.
UO Medicina Generale a indirizzo Diabetologico e Endocrino-Metabolico, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Diabetologia pediatrica, Via Sergio Pansini 5, 80131, Naples
Universita Degli Studi Di Messina
DAI Materno Infantile, Via Consolare Valeria 1, 98125, Messina
Azienda Ospedaliera Universitaria Integrata Verona
Pediatria B, Piazzale Aristide Stefani 1, 37126, Verona
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 di Padova
UOSD Diabetologia Pediatrica e Malattie Metaboliche dell'Età Evolutiva, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera di Padova
UOC Malattie del Metabolismo, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
S.O.D. DIABETOLOGIA PEDIATRICA, Via Filippo Corridoni 11, 60123, Ancona
Azienda Ospedaliero Universitaria Careggi
Diabetologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Diabeter Nederland B.V.
Pediatrician-Diabetologist, Blaak 6, 3011 TA, Rotterdam
Oslo Universitetssykehus HF
Unit for Endocrinology and Diabetes, Divison for pediatric and Adolescent Medicine, Kirkeveien 166, 0450, Oslo
Akershus University Hospital
Dept. Pediatrics and Adolescent Medicine, Sykehusveien 25, 1474, Loerenskog
St. Olavs Hospital HF
Department of Pediatrics, Prinsesse Kristinas Gate 3, 7030, Trondheim
Helse Fonna HF
Pediatric department, Karmsundgata 120, 5528, Haugesund
Oslo Universitetssykehus HF
Dept. Endocrinology, Morbid obesity and Preventive Medicine, Trondheimsveien 235, 0586, Oslo
Helse Stavanger HF
Medical and Endocrinological department, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Uniwersyteckie Centrum Kliniczne
N/A, Ul. Debinki 7, 80-952, Gdansk
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
N/A, Ul Tytusa Chalubinskiego 2-2a, 50-368, Wroclaw
Mtz Clinical Research Powered By Pratia
N/A, Ul. Gładka 22, 02-172, Warsaw
Umed Clinical Trials Sp. z o.o.
N/A, Bud A-2, Ul. Pomorska 251, Lodz
Unidade Local De Saude Do Alto Minho E.P.E.
Endocrinology, 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
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
Hospital Universitario Ramon Y Cajal
Endocrinology & Nutrition, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Y Politecnico La Fe
Pediatric Endocrinology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Digestive and Metabolic Diseases, Calle Villarroel 170, 08036, Barcelona
University Hospital Virgen Del Rocio S.L.
Pediatric Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Cruces
Pediatric Endocrinology, Cruces Plaza S/n, 48903, Barakaldo
Hospital De La Santa Creu I Sant Pau
Endocrinology & Nutrition, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes & Nutrition, Avenida Valdecilla Sn, 39008, Santander
University Hospital Virgen Del Rocio S.L.
Endocrinology & Nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Sant Joan De Deu Barcelona
Pediatric Endocrinology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Region Oerebro Laen
Department of Pediatrics and Adolescent Medicine, Sodra Grev Rosengatan, 701 85, Orebro
ProbarE i Lund AB
ProbarE i Lund, S Domkyrkofors., Lilla Fiskaregatan 10, Lund
ProbarE i Stockholm AB
ProbarE i Stockholm, Brahegatan 30, Hedvig Eleonora Forsamling, Stockholm
Region Jaemtland Haerjedalen
Medicin, Kyrkgatan 12, 831 50, Ostersund
NU Hospital Group-Vaestra Goetalandsregionen
Specialistmedicin, Fjallvagen 9, Bave Forsamling, Uddevalla
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 | 2026-02-03 | 2026-02-05 | |||
| Finland | 2026-04-23 | 2026-05-19 | |||
| Germany | 2026-02-05 | 2026-03-12 | |||
| Italy | 2026-03-11 | 2026-03-25 | |||
| Norway | 2026-04-14 | 2026-04-28 | |||
| Poland | 2026-02-23 | 2026-03-04 | |||
| Portugal | 2026-03-17 | 2026-03-20 | |||
| Spain | 2026-02-06 | 2026-02-13 | |||
| Sweden | 2026-05-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2026-05-27
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with CTR Q&A / point 1.23, the sponsor is asked to submit a substantial modification application (Part II only) in order to update the CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 215 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_Redacted 2025-522170-36-00 | c |
| Protocol (for publication) | D4_Patient facing documents_Copyright Statement | 1.0 |
| Recruitment arrangements (for publication) | K1_Informed consent and Patient Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean_NO | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FI | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_JAJK | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_JAJK_TC | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC_FI | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment_SE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangments_PT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Brochure | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Poster_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Brochure_Master_PT | 2 |
| 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_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_Document additionnel_JAJK | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_Master_PT | 2 |
| 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 | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material _Clinical Research Studies Brochure Parents Caregivers | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure CYP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Parents Caregivers | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Parents Caregivers_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Track changes | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-CYP_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-CYP_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-Parents-Caregivers_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure-Parents-Caregivers_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Research Studies Brochure Parents Caregivers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Brochure CYP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Brochure CYP_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Phases | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Research-Studies-Brochure-Parents-Caregivers_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Brochure-CYP_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_clean_NO | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter doctor referral | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor_Referral_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor_Referral_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_clean_NO | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 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-Screening_Master_PT | 3 |
| Recruitment arrangements (for publication) | K2_Visit-Card_Master_PT | 1 |
| Recruitment arrangements (for publication) | K3_Patient Recruitment Procedure and Informed Consent | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_Assent_12 to less than 16y_PT | V3PRT_V1.0 |
| Subject information and informed consent form (for publication) | L1_CountrySpecific_Assent_5 to 11y_PT | 1 |
| Subject information and informed consent form (for publication) | L1_CountrySpecific_ICF_Pregnancy_PT | 2 |
| 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_Main_PT | V4PRT_V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_Older Children_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_Younger Children 7-11 | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parents_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_16-17 years_clean_NO | 4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Optional Genetic Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 12-14 yr_clean_FI | V2.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 12-14 yr_TC_FI | V2.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 15-17 yr_clean_FI | V3.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent 15-17 yr_TC_FI | V3.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adolescent Assent Form_clean_NO | 3.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Child | 1 |
| 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 older child | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Teenager | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent younger child | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11 a 17 ans_JAJK_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11 a 17 ans_JAJK_FRA_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_7 a 11ans_JAJK_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent 6-11 yr_clean_FI | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent 6-11 yr_TC_FI | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Assent Form_clean_NO | 1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Consent Form_12-16 years | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Parent_FI_Clean | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Parent_FI_TC | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_clean_NO | 1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_FI_Clean | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_FI_TC | V1.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF for parents and guardians | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_clean_NO | 4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF | 1.2 |
| 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_JAJK_FRA_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_JAJK_PL_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Legal Rep_JAJK_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_clean_NO | 4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental Appendix_clean_FI | V3.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental Appendix_TC_FI | V3.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_FI_Clean | V3.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_FI_TC | V3.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adults_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Assent 12-14 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Assent 15-17 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parents_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Notification to Guardians_clean_FI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent Form_BEDU | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent Form_BEFR | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent Form_ENG | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent_JAJK_PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent DPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner or Pregnant participant_swe | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_clean_FI | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_clean_NO | 1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_TC_FI | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research subject 15-17 years Information and consent form_swe | V4SWEV1.0 |
| 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 | V3SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form for adult participant_swe | V4SWEV1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form for parents or legal guardian_swe | V4SWEV1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent Form_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent Form_BEFR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent Form_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Children Assent Form | 1.1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_confidentiality sheet | 2 |
| 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_Confidentiality Notice_Phase 3 and 4 Trials only_PT | 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 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Certificate Participation_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Brochure-CYP_PL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_for publication | 1.0 |
| 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 _PL | 1.0 |
| 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_ODS-IFU-CT_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ODS-IFU-CT_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Oral Suspension IFU | 1 |
| 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_Passport Stickers_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Passport_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient below 13 years | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment brochure_PL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment flyer_PL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment poster_PL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide_swe | 2 |
| 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_Thank You Dropout_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You End Of Study_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Participation_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Retention_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Screening_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Card_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Participant Guide Dexcom G7 | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Patient Card_JAJK | 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_Patient Cards | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Retention material_Certificate Participation | 2.0 |
| Subject information and informed consent form (for publication) | L2_Retention material_Passport | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Passport Stickers | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_School Note Generic | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Site Certificate FPV Milestone | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study Guide Master | 1 |
| 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 | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1.0 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure_PL | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Olumiant | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522170-36-00_FRA | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FI_2025-522170-36-00_Clean | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PRT_2025-522170-36-00 | c |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_IT_2025-522170-36-00 | c |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Italy | Acceptable with conditions 2026-02-02
|
2026-02-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-11 | Italy | Acceptable with conditions 2026-02-02
|
2026-05-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-19 | Acceptable with conditions | 2026-05-18 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-20 | Acceptable with conditions | 2026-04-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-25 | Acceptable with conditions | 2026-04-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-26 | Acceptable with conditions | 2026-05-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-26 | Acceptable with conditions | 2026-04-21 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-27 | Acceptable with conditions | 2026-06-01 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-27 | Acceptable with conditions | 2026-05-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-03-27 | Acceptable with conditions | 2026-04-21 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-10 | Italy | Acceptable with conditions | 2026-05-26 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-21 | Acceptable with conditions | 2026-05-19 |