Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
184
Countries
9
Sites
37
Juvenile Idiopathic Arthritis
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 10 Sep 2019 → ongoing
- Decision date (initial)
- 2024-04-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506131-15-00
- EudraCT number
- 2017-004471-31
- WHO UTN
- U1111-1300-7540
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacogenetic, Therapy, Pharmacogenomic, Pharmacodynamic, Efficacy
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17
Conditions and MedDRA coding
Juvenile Idiopathic Arthritis
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 2
- Participants must have completed a previous study of baricitinib for the treatment of JIA
- Participants must have not developed an allergy to baricitinib
Exclusion criteria 2
- Participants must not have permanently stopped baricitinib in the prior study
- Participants must have not developed an allergy to baricitinib
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Number of participants with one or more SAEs
- Number of participants with permanent investigational product discontinuations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7392 mg milligram(s)
- Max treatment duration
- 264 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- 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
- 7392 mg milligram(s)
- Max treatment duration
- 264 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 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.
PRD10309000 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7392 mg milligram(s)
- Max treatment duration
- 264 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
- 7392 mg milligram(s)
- Max treatment duration
- 264 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 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.
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 10
| Organisation | City, country | Duties |
|---|---|---|
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 10 |
| Q2 Solutions ORL-000005107
|
West Lothian, United Kingdom | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| Pediatric Rheumatology International Trials Organization (PRINTO) ORL-000005108
|
Genova, Italy | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
Locations
9 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1 | 2 |
| Belgium | Ongoing, recruiting | 7 | 3 |
| Czechia | Ongoing, recruiting | 10 | 4 |
| Denmark | Ended | 1 | 2 |
| France | Ongoing, recruiting | 10 | 5 |
| Germany | Ongoing, recruiting | 23 | 5 |
| Italy | Ongoing, recruiting | 11 | 8 |
| Poland | Ongoing, recruiting | 9 | 3 |
| Spain | Ongoing, recruiting | 11 | 5 |
| Rest of world
Turkey, India, Mexico, Russian Federation, Israel, Australia, Brazil, Japan, Argentina, China, United Kingdom
|
— | 101 | — |
Investigational sites
LKH Bregenz
Department of Pediatrics and Adolescent Medicine, Carl-Pedenz-Straße 2, 6900, Bregenz
Medical University Of Vienna
Department of Pediatrics and Adolescent Medicine, Waehringer Guertel 18-20, Alsergrund, Vienna
Universitair Ziekenhuis Gent
Pediatric rheumatology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Kinderreumatologie, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Hematology oncology pediatric, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Vseobecna Fakultni Nemocnice V Praze
reumatology, Ke Karlovu 455/2, Nove Mesto, Prague 2
University Hospital Olomouc
reumatology, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
reumatology, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Brno
reumatology, Cernopolni 9, Cerna Pole, Brno-Sever
Aarhus Universitetshospital
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
BørneUngeAfdelingen, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Poitiers
RHUMATOLOGIE, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Necker Enfants Malades
Unite d'Immunologie-Hematologie et Rhumatologie Pediatriques, 149 Rue De Sevres, 75015, Paris
Hospices Civils De Lyon
Hospices Civils de Lyon - Hôpital Femme Mère Enfant, 59 Boulevard Pinel, 69500, Bron
Bicetre Hospital
Rhumatologie pediatrique et CEREMAIA, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Nimes
Service de pédiatrie, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
HELIOS Klinikum Berlin-Buch GmbH
N/A, Schwanebecker Chaussee 50, Buch, Berlin
Universitaetsklinikum Tuebingen AöR
N/A, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Charite Universitaetsmedizin Berlin KöR
N/A, Augustenburger Platz 1, Wedding, Berlin
Asklepios Klinik Sankt Augustin GmbH
N/A, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Zentrum für Kinder- und Jugendrheumatologie
N/A, Dehnhaide 120, Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Clinica Pediatrica, Piazzale Spedali Civili 1, 25123, Brescia
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Clinica Pediatrica, Via Dell' Istria 65/1, 34137, Trieste
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC PEDIATRIA MEDIA INTENSITA' DI CURA, Via Della Commenda 12, 20122, Milan
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
UOSD di Pediatria ad indirizzo reumatologico, Via Dei Vestini Snc, 66100, Chieti
Giannina Gaslini Institute For Scientific Hospitalization And Care
U.O.C. Clinica Pediatrica e Reumatologia, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento Scienze Mediche Traslazionali, Via Sergio Pansini 5, 80131, Naples
ARNAS Civico di Cristina Benfratelli
Dipartimento di Pediatria, 5 Via dei Benedettini, 90127, Palermo
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Reumatologia Pediatrica, Via Gaetano Pini, 9, Milano
CSK, Uniwersyteckie Centrum Pediatrii im. M.Konopnickiej
Hospital, ul. Sporna 36/50, 91-738, Lodz
Szpital Dzieciecy Sw. Ludwika III Oddział Kliniczny Pediatrii Reumatologii z pododdziałem alergologi
Hospital, ul Strzelecka 2, 31-503, Krakow
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji, Klinika Reumatologii Wieku Rozwojowego
Hospital, ul. Spartanska 1, 02-637, Warszawa
Sant Joan De Deu Barcelona Hospital
Pediatric Reumatology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario Y Politecnico La Fe
Pediatric Reumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Pediatric Reumatology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Ramon Y Cajal
Pediatric Reumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Infantil Universitario Nino Jesus
Pediatric Reumatology, Avenida Menendez Pelayo 65, 28009, 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 | 2019-09-10 | 2021-09-01 | |||
| Belgium | 2020-08-10 | 2023-07-12 | |||
| Czechia | 2020-01-16 | 2020-08-05 | |||
| Denmark | 2020-08-18 | 2025-11-04 | 2020-09-11 | ||
| France | 2020-02-21 | 2020-05-07 | |||
| Germany | 2019-09-25 | 2019-10-24 | |||
| Italy | 2020-02-18 | 2020-04-02 | |||
| Poland | 2020-04-02 | 2020-04-14 | |||
| Spain | 2019-12-19 | 2020-04-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 56 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506131-15-00_Redacted | e |
| Protocol (for publication) | D4_Copyright statement_Patient facing materials | 1.0 |
| Recruitment arrangements (for publication) | Blank statement | 1.0 |
| Recruitment arrangements (for publication) | Blank statement | N/A |
| Recruitment arrangements (for publication) | Blanket Statement - Document not published anymore | 2.0 |
| Recruitment arrangements (for publication) | K1_Blank statement | 1 |
| Recruitment arrangements (for publication) | K1_Blank statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Older | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Younger | 1.0 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland_PL | 1 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 16 Plus_PL_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Older Children DU | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children ENG | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Children FR | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Younger Children DU | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Younger Children ENG | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Younger Children FR | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Adults_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Assent form 12-14years | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Assent form 15-17years_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Data Privacy Addendum_Adult | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Data Privacy Addendum_Parents | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF JAHX_Parents_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF BEDU | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF BEFR | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF ENG | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Older Child Assent_PL | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parents_PL_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger Child Assent_PL | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Asentimiento 12-18 anos | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adultos | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Asentimiento menores | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Padres | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Adult_ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Emergency Card_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material UCT_OLDER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material UCT_YOUNGER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instruction for use_BARICITINIB | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient information ard | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_Info Re-insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_Study Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tarjetas paciente | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Visit Guide DU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Visit Guide ENG | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Visit Guide FR | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Simplified IMPD Baricitinib | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-506131-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-506131-15-00_TC | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GER_2023-506131-15-00 | e |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Spain | Acceptable 2024-04-04
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-05 | Acceptable | 2024-11-13 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-23 | Spain | Acceptable | 2024-12-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-24 | Acceptable | 2025-02-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-21 | Spain | Acceptable | 2025-04-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-10 | Acceptable | 2025-03-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-28 | Acceptable | 2025-06-16 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-22 | Acceptable | 2025-07-22 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-13 | Spain | Acceptable | 2025-08-13 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-13 | Acceptable | 2026-03-13 |