A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

2023-505811-18-00 Protocol I4V-MC-JAHW Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 11 Nov 2019 · Status Ongoing, recruiting · 3 EU/EEA countries · 7 sites · Protocol I4V-MC-JAHW

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 35
Countries 3
Sites 7

Uveitis

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Pediatric, Patients
Age range
0-17 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20]
Trial duration
11 Nov 2019 → ongoing
Decision date (initial)
2024-03-07
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-505811-18-00
EudraCT number
2019-000119-10
WHO UTN
U1111-1298-6167

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Conditions and MedDRA coding

Uveitis

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 5

  1. Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
  2. Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
  3. Participants must have an inadequate response or intolerance to MTX.
  4. Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
  5. Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.

Exclusion criteria 8

  1. Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
  2. Participants must not have any contraindications to adalimumab.
  3. Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
  4. Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
  5. Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
  6. Participants must not have a current or recent (<4 weeks prior to baseline) infection.
  7. Participants must not have a positive test for hepatitis B virus (HBV) at screening.
  8. Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Response is defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Baricitinib

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
7952 mg milligram(s)
Max treatment duration
284 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.

Baricitinib

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
7952 mg milligram(s)
Max treatment duration
284 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.

Baricitinib

PRD10309000 · Product

Active substance
Baricitinib
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
4 mg milligram(s)
Max total dose
7952 mg milligram(s)
Max treatment duration
284 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Baricitinib

PRD10162774 · Product

Active substance
Baricitinib
Pharmaceutical form
ORAL SUSPENSION
Route of administration
ORAL USE
Max daily dose
4 mg milligram(s)
Max total dose
7952 mg milligram(s)
Max treatment duration
284 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
Yes
Orphan designation
No

Comparator 2

Adalimumab

SUB20016 · Substance

Active substance
Adalimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
3840 mg milligram(s)
Max treatment duration
120 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Adalimumab

SUB20016 · Substance

Active substance
Adalimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
3840 mg milligram(s)
Max treatment duration
120 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
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
Lill

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lill

Third parties 9

OrganisationCity, countryDuties
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Data management
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring
Quintiles Laboratories Europe
ORG-100017355
 Livingston, United Kingdom Laboratory analysis
Macrostat (Shanghai) Clinical Research Co. Ltd.
ORG-100048828
 Shanghai, China Code 10
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management
Bioclinica Inc.
ORG-100033079
 Princeton, United States Laboratory analysis
Publicis Healthcare Communications Group Limited
ORG-100044665
 London, United Kingdom Other
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Data management

Locations

3 EU/EEA countries · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ongoing, recruiting 10 3
Italy Ongoing, recruiting 4 1
Spain Ongoing, recruiting 5 3
Rest of world
United Kingdom
 — 16 —

Investigational sites

Germany

3 sites · Ongoing, recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Kompetenzzentrum für Sklerodermie im Kindes- und Jugendalter, Dehnhaide 120, 22081, Hamburg
HELIOS Klinikum Berlin-Buch GmbH
N/A, Schwanebecker Chaussee 50, Buch, Berlin
Charite Universitaetsmedizin Berlin KöR
N/A, Augustenburger Platz 1, Wedding, Berlin

Italy

1 site · Ongoing, recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Reumatologia, Viale Gaetano Pieraccini 24, 50139, Florence

Spain

3 sites · Ongoing, recruiting
Hospital Universitario La Paz
Pediatric Reumatology, Paseo Castellana 261, 28046, Madrid
Hospital Infantil Universitario Nino Jesus
Pediatric Reumatology, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital Universitario Y Politecnico La Fe
Pediatric Reumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2020-10-01 2020-12-01
Italy 2019-12-20 2020-10-12
Spain 2019-11-11 2019-11-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Subject information and informed consent form (for publication) L1_SIS and ICF Main 1
Subject information and informed consent form (for publication) L1_SIS and ICF Padres 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Asentimiento_ninos mayores 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Asentimiento_ninos menores 1
Subject information and informed consent form (for publication) L2_Other subject information material_Tarjetas paciente 1

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-01-19 Italy Acceptable
2024-03-04
 2024-03-04
2 SUBSTANTIAL MODIFICATION SM-2 2024-04-04 Italy Acceptable
2024-06-03
 2024-06-04
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-01-22 Italy Acceptable
2024-06-03
 2025-01-22
4 SUBSTANTIAL MODIFICATION SM-3 2025-02-21 Acceptable 2025-04-04
5 NON SUBSTANTIAL MODIFICATION NSM-2 2025-08-13 Italy Acceptable 2025-08-13