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
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants must not have any to adalimumab.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Administered orally
Also known as: LY3009104
Administered SC
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Baricitinib | Adalimumab |
|---|---|---|
| Started | 25 | 5 |
| Received at least 1 dose of study drug | 24 | 5 |
| Completed | 10 | 0 |
| Not completed | 15 | 5 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Did not meet randomization criteria | 2 | 0 |
| Withdrew: Lack of efficacy | 9 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Per protocol, participants in the adalimumab group discontinued the study | 0 | 4 |
| Milestone | Baricitinib | Adalimumab |
|---|---|---|
| Started | 10 | 0 |
| Completed | 0 | 0 |
| Not completed | 10 | 0 |
| Withdrew: Ongoing treatment | 10 | 0 |
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.
| Percentage of participants | Baricitinib |
|---|---|
| Part A: Percentage of Responders for Baricitinib at Week 24 | 33.3 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.
Results for this outcome have not been posted.
Collected over Baseline Up To 55 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baricitinib | 0/24 (0%) | 2/24 (8.3%) | 16/24 (66.7%) |
| Adalimumab | 0/5 (0%) | 1/5 (20%) | 4/5 (80%) |
| Event | Baricitinib | Adalimumab |
|---|---|---|
| Juvenile idiopathic arthritisMusculoskeletal and connective tissue disorders | 0/24 | 1/5 |
| UveitisEye disorders | 1/24 | 0/5 |
| Intentional overdoseInjury, poisoning and procedural complications | 1/24 | 0/5 |
| Event | Baricitinib | Adalimumab |
|---|---|---|
| Iron deficiency anaemiaBlood and lymphatic system disorders | 0/24 | 1/5 |
| Macular oedemaEye disorders | 0/24 | 1/5 |
| Abdominal pain upperGastrointestinal disorders | 3/24 | 1/5 |
| Adverse drug reactionGeneral disorders | 0/24 | 1/5 |
| IllnessGeneral disorders | 0/24 | 1/5 |
| PyrexiaGeneral disorders | 3/24 | 1/5 |
| Covid-19Infections and infestations | 1/24 | 1/5 |
| NasopharyngitisInfections and infestations | 2/24 | 1/5 |
| Otitis mediaInfections and infestations | 0/24 | 1/5 |
| Urinary tract infectionInfections and infestations | 1/24 | 1/5 |
All participants who received at least one dose of study drug.
| Age, Continuous(years) | Baricitinib | Adalimumab | Total |
|---|---|---|---|
| Mean | 11.60 ± 3.53 | 6.60 ± 2.51 | 10.70 ± 3.84 |
| Sex: Female, Male(Participants) | Baricitinib | Adalimumab | Total |
|---|---|---|---|
| Female | 14 | 5 | 19 |
| Male | 10 | 0 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Baricitinib | Adalimumab | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 12 | 4 | 16 |
| Unknown or Not Reported | 10 | 1 | 11 |
| Race (NIH/OMB)(Participants) | Baricitinib | Adalimumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 20 | 4 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Region of Enrollment(Participants) | Baricitinib | Adalimumab | Total |
|---|---|---|---|
| France | 4 | 0 | 4 |
| Germany | 1 | 1 | 2 |
| Italy | 3 | 2 | 5 |
| Spain | 3 | 0 | 3 |
| United Kingdom | 13 | 2 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · vivli.org
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Studies of the drug tested here: Baricitinib