CClinicalTrials.gg
Sign In
Active, not recruitingNCT04088409Updated Apr 24, 2026Results posted

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

A Phase 3 interventional study of Baricitinib and Adalimumab in Uveitis, sponsored by Eli Lilly and Company. Active, not recruiting at 20 sites in 5 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Uveitis

Browse trials for

03

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Baricitinib

    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

  • Active comparator
    Adalimumab

    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

  • DrugBaricitinib

    Administered orally

    Also known as: LY3009104

  • DrugAdalimumab

    Administered SC

05

What researchers measure

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.

    Time frame: Week 24

Secondary outcomes

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

    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

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

    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

  3. Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline

    Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. Outcome data will be provided after the study is completed.

    Time frame: Week 24

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

    Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

  5. Change From Baseline in Vitreous Haze

    Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

  6. Change From Baseline in Grade of Flare in the Anterior Chamber

    Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

  7. Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)

    Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.

    Time frame: Week 24

  8. Time to Inactive Anterior Uveitis Disease (Using SUN Definition)

    Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.

    Time frame: Baseline through Week 24

  9. Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

    Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to \<2 Drops Per Day. Outcome data will be provided after the study is completed.

    Time frame: Week 24

  10. Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)

    PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.

    Time frame: Week 24

  11. Change From Baseline in Overall Uveitis-Related Disability

    Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.

    Time frame: Baseline, Week 24

06

Results

Posted Aug 13, 2024

Participant flow

Overall, 30 participants were enrolled in the study. One participant (in baricitinib arm) withdrew from the study before administration of the study drug. This study is conducted in 2 parts. Part A (24 weeks) and Part B (260 weeks). Participants assigned to baricitinib and completed the Part A as a responder continued receiving baricitinib until the end of study or discontinuation from the study.

Part A
Participant flow — Part A
MilestoneBaricitinibAdalimumab
Started255
Received at least 1 dose of study drug245
Completed100
Not completed155
Withdrew: Withdrawal by subject21
Withdrew: Did not meet randomization criteria20
Withdrew: Lack of efficacy90
Withdrew: Lost to follow-up10
Withdrew: Adverse event10
Withdrew: Per protocol, participants in the adalimumab group discontinued the study04
Part B
Participant flow — Part B
MilestoneBaricitinibAdalimumab
Started100
Completed00
Not completed100
Withdrew: Ongoing treatment100

Outcome measures

PrimaryPart 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.

Time frame:
Week 24
Reported as:
Number · Percentage of participants
Part A: Percentage of Responders for Baricitinib at Week 24
Percentage of participantsBaricitinib
Part A: Percentage of Responders for Baricitinib at Week 2433.3
SecondaryChange From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

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

Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

SecondaryPercentage of Responders in Participants With Bilateral Uveitis Disease at Baseline

Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. Outcome data will be provided after the study is completed.

Time frame:
Week 24

Results for this outcome have not been posted.

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

Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

SecondaryChange From Baseline in Vitreous Haze

Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

SecondaryChange From Baseline in Grade of Flare in the Anterior Chamber

Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)

Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.

Time frame:
Week 24

Results for this outcome have not been posted.

SecondaryTime to Inactive Anterior Uveitis Disease (Using SUN Definition)

Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.

Time frame:
Baseline through Week 24

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to \<2 Drops Per Day. Outcome data will be provided after the study is completed.

Time frame:
Week 24

Results for this outcome have not been posted.

SecondaryPediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)

PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.

Time frame:
Week 24

Results for this outcome have not been posted.

SecondaryChange From Baseline in Overall Uveitis-Related Disability

Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.

Time frame:
Baseline, Week 24

Results for this outcome have not been posted.

Adverse events

Collected over Baseline Up To 55 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Baricitinib0/24 (0%)2/24 (8.3%)16/24 (66.7%)
Adalimumab0/5 (0%)1/5 (20%)4/5 (80%)
Most frequent serious events
Most frequent serious events
EventBaricitinibAdalimumab
Juvenile idiopathic arthritisMusculoskeletal and connective tissue disorders0/241/5
UveitisEye disorders1/240/5
Intentional overdoseInjury, poisoning and procedural complications1/240/5
Most frequent other events
Showing 10 of 25
Most frequent other events
EventBaricitinibAdalimumab
Iron deficiency anaemiaBlood and lymphatic system disorders0/241/5
Macular oedemaEye disorders0/241/5
Abdominal pain upperGastrointestinal disorders3/241/5
Adverse drug reactionGeneral disorders0/241/5
IllnessGeneral disorders0/241/5
PyrexiaGeneral disorders3/241/5
Covid-19Infections and infestations1/241/5
NasopharyngitisInfections and infestations2/241/5
Otitis mediaInfections and infestations0/241/5
Urinary tract infectionInfections and infestations1/241/5

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)BaricitinibAdalimumabTotal
Mean11.60 ± 3.536.60 ± 2.5110.70 ± 3.84
Sex: Female, Male
Sex: Female, Male(Participants)BaricitinibAdalimumabTotal
Female14519
Male10010
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BaricitinibAdalimumabTotal
Hispanic or Latino202
Not Hispanic or Latino12416
Unknown or Not Reported10111
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BaricitinibAdalimumabTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White20424
More than one race000
Unknown or Not Reported404
Region of Enrollment
Region of Enrollment(Participants)BaricitinibAdalimumabTotal
France404
Germany112
Italy325
Spain303
United Kingdom13215
07

Study locations

20 sites
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
    Le Kremlin-Bicêtre, 94270, France
  • Hôpital Universitaire Necker Enfants Malades
    Paris, 75015, France
  • Centre Hospitalier Universitaire de Poitiers
    Poitiers, 86021, France
  • Asklepios Klinik Sankt Augustin
    Sankt Augustin, North Rhine-Westphalia 53757, Germany
  • HELIOS Klinikum Berlin-Buch
    Berlin, 13125, Germany
  • Charité Campus Virchow-Klinikum
    Berlin, 13353, Germany
  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
    Hamburg, 22081, Germany
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    Milan, Lombardy 20122, Italy
  • Azienda Ospedaliero Universitaria Meyer
    Florence, 50100, Italy
  • Hospital Sant Joan de Déu
    Esplugues de Llobregat, Barcelona 08950, Spain
  • Hospital Infantil Universitario Niño Jesús
    Madrid, Madrid, Comunidad de 28009, Spain
  • Hospital Universitario La Paz
    Madrid, Madrid, Comunidad de 28046, Spain
  • Hospital Universitario La Fe de Valencia
    Valencia, 46026, Spain
  • Bristol Royal Hospital for Children
    Bristol, Bristol, City of BS2 8BJ, United Kingdom
  • Cambridge Clinical Research Facility
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Alder Hey Children's Hospital
    Liverpool, England L14 5AB, United Kingdom
  • Royal Victoria Infirmary
    Newcastle upon Tyne, England NE1 4LP, United Kingdom
  • University Hospital Southampton NHS Foundation Trust
    Southampton, Hampshire SO16 0YD, United Kingdom
  • Great Ormond Street Hospital For Children NHS Foundation Trust
    London, WC1N 3JH, United Kingdom
  • Sheffield Children's Hospital
    Sheffield, S10 2TH, United Kingdom
08

References and documents

Publications

  • 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. PubMed 34627340 ↗

Study documents

  • Study protocol · Jun 14, 2023
  • Statistical analysis plan · Aug 13, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT04088409
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Oct 16, 2019
Primary completion
Jul 17, 2023
Completion
Jul 2028 (estimated)
Results posted
Aug 13, 2024
Last update
Apr 24, 2026

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Uveitis→

Other studies from this sponsor

Eli Lilly and Company

Start the discussion