UveitisPhase 3NCT04088409
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 study testing Baricitinib and Adalimumab in people with Uveitis, run by Eli Lilly and Company at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Baricitinib and Adalimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 16 Oct 2019to Jul 2028
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United Kingdom7 sites
Bristol Royal Hospital for Children
Bristol, Bristol, City of, BS2 8BJ
Cambridge Clinical Research Facility
Cambridge, Cambridgeshire, CB2 0QQ
Alder Hey Children's Hospital
Liverpool, England, L14 5AB
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Sheffield Children's Hospital
Sheffield, S10 2TH
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 0YD
Germany4 sites
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Charité Campus Virchow-Klinikum
Berlin, 13353
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, 22081
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, 53757
Spain4 sites
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, 28009
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046
Hospital Universitario La Fe de Valencia
Valencia, 46026
France3 sites
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Italy2 sites
Azienda Ospedaliero Universitaria Meyer
Florence, 50100
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
About this study
Official title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive 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.
- Conditions
- Uveitis
- Being tested
- Baricitinib, Adalimumab
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
AdalimumabDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (11)
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.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
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.
Measured: Week 24
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.
Measured: Baseline, Week 24
Change From Baseline in Vitreous Haze
Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
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.
Measured: Week 24
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.
Measured: Baseline through Week 24
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.
Measured: Week 24
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.
Measured: Week 24
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.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start16 Oct 2019
- Primary completion17 Jul 2023
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088409
- Sponsor's protocol ID
- 16277
- Other IDs
- I4V-MC-JAHW, 2019-000119-10, 2019
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2019
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
- ClinicalTrials.gov ID
- NCT04088409
- Acronym / sponsor ID
- 16277
- Conditions
- Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: BaricitinibParticipants ≥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. |
| Adalimumab | Active comparator | Drug: AdalimumabParticipants 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104Administered orally | Drug | Baricitinib |
| AdalimumabAdministered SC | Drug | Adalimumab |
Primary outcome
Part A: Percentage of Responders for Baricitinib at Week 24
Time frame: 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.
11 secondary outcomes
Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye
Time frame: Baseline, Week 24
Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)
Time frame: Baseline, Week 24
Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline
Time frame: Week 24
Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test
Time frame: Baseline, Week 24
Change From Baseline in Vitreous Haze
Time frame: Baseline, Week 24
Change From Baseline in Grade of Flare in the Anterior Chamber
Time frame: Baseline, Week 24
Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)
Time frame: Week 24
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
Time frame: Baseline through Week 24
Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
Time frame: Week 24
Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)
Time frame: Week 24
Change From Baseline in Overall Uveitis-Related Disability
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34627340Ramanan 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.
- 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 UveitisLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Uveitis
RecruitingObservational study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Presumed Trematode Induced Uveitis, Uveitis
Not yet recruitingObservational study
The Microbiome in Uveitis and Pediatric Inflammatory Diseases
Noninfectious Uveitis
RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Active Non-anterior, Non-infectious Uveitis
RecruitingObservational study
PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT
Uveitis
Active, not recruitingPhase 3
A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
Non-infectious Anterior Uveitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib and Adalimumab in people with Uveitis, run by Eli Lilly and Company at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, Germany, Spain, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Percentage of Responders for Baricitinib at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04088409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.