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

NCT04088409 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: 16277I4V-MC-JAHW2019-000119-10
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 20

Brief Summary

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

Uveitis

Outcome Measures

Primary Outcomes (1)

• Part A: Percentage of Responders for Baricitinib at Week 24

  Response was 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.

  Week 24

Secondary Outcomes (11)

• Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

  Baseline, Week 24

• Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)

  Baseline, Week 24

• Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline

  Week 24

• Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test

  Baseline, Week 24

• Change From Baseline in Vitreous Haze

  Baseline, Week 24

Study Arms (2)

Baricitinib

EXPERIMENTAL

Participants ≥9 to \<18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants \<9 years of age were administered 2 mg baricitinib QD. Participants \<6 years of age received an oral suspension. Participants ≥6 to \<12 years of age had the option of receiving an oral suspension. Participants \>12 years of age were supplied tablets.

Drug: Baricitinib

Adalimumab

ACTIVE COMPARATOR

Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.

Drug: Adalimumab

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib

Adalimumab DRUG

Administered SC

Adalimumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
• 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).
• Participants must have an inadequate response or intolerance to MTX.
• 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.
• 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.

You may not qualify if:

• Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
• Participants must not have any contraindications to adalimumab.
• 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.
• 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.
• Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
• Participants must not have a current or recent (\<4 weeks prior to baseline) infection.
• Participants must not have a positive test for hepatitis B virus (HBV) at screening.
• Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (20)

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Universitaire Necker Enfants Malades

Paris, 75015, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Asklepios Klinik Sankt Augustin

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, 22081, Germany

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Azienda Ospedaliero Universitaria Meyer

Florence, 50100, Italy

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, 46026, Spain

Location

Bristol Royal Hospital for Children

Bristol, Bristol, City of, BS2 8BJ, United Kingdom

Location

Cambridge Clinical Research Facility

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, England, L14 5AB, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 0YD, United Kingdom

Location

Great Ormond Street Hospital For Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

Related Publications (1)

• Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5.

  PMID: 34627340 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Uveitis

Interventions

baricitinib; Adalimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: October 16, 2019
• Primary Completion: July 17, 2023
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 24, 2026
• Results First Posted: August 13, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

GB (7); IT (2); FR (3); ES (4); DE (4)