Trial Outcomes & Findings for 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 (NCT NCT04088409)

Last Updated: 2025-04-20

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Week 24

Results posted on

2025-04-20

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.

Participant milestones

Participant milestones
Measure	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.	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.
Part A STARTED	25	5
Part A Received At Least 1 Dose of Study Drug	24	5
Part A COMPLETED	10	0
Part A NOT COMPLETED	15	5
Part B STARTED	10	0
Part B COMPLETED	0	0
Part B NOT COMPLETED	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Part A Withdrawal by Subject	2	1
Part A Did Not Meet Randomization Criteria	2	0
Part A Lack of Efficacy	9	0
Part A Lost to Follow-up	1	0
Part A Adverse Event	1	0
Part A Per Protocol, Participants in the Adalimumab Group Discontinued the Study	0	4
Part B Ongoing Treatment	10	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baricitinib n=24 Participants Participants ≥9 to \<18 years of age were administered 4 mg baricitinib 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 n=5 Participants Participants received adalimumab administered SC once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kg, or 40 mg every 2 weeks for participants weighing ≥30 kg.	Total n=29 Participants Total of all reporting groups
Age, Continuous	11.60 years STANDARD_DEVIATION 3.53 • n=93 Participants	6.60 years STANDARD_DEVIATION 2.51 • n=4 Participants	10.70 years STANDARD_DEVIATION 3.84 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	5 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	0 Participants n=4 Participants	10 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	4 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants	1 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	4 Participants n=4 Participants	24 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment France	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment Germany	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment Italy	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment Spain	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United Kingdom	13 Participants n=93 Participants	2 Participants n=4 Participants	15 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All participants who received at least one dose of baricitinib in Part A.

Outcome measures

Outcome measures
Measure	Baricitinib n=24 Participants Participants ≥9 to \<18 years of age were administered 4 mg baricitinib 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.
Part A: Percentage of Responders for Baricitinib at Week 24	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Outcome measures

Outcome data not reported

Adverse Events

Baricitinib

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Adalimumab

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baricitinib n=24 participants at risk Participants ≥9 to \<18 years of age were administered 4 mg baricitinib 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 n=5 participants at risk Participants received adalimumab administered SC once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kg, or 40 mg every 2 weeks for participants weighing ≥30 kg.
Eye disorders Uveitis	4.2% 1/24 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Intentional overdose	4.2% 1/24 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Baricitinib n=24 participants at risk Participants ≥9 to \<18 years of age were administered 4 mg baricitinib 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 n=5 participants at risk Participants received adalimumab administered SC once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kg, or 40 mg every 2 weeks for participants weighing ≥30 kg.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Eye disorders Macular oedema	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	12.5% 3/24 • Number of events 3 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	16.7% 4/24 • Number of events 4 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	12.5% 3/24 • Number of events 3 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
General disorders Adverse drug reaction	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
General disorders Illness	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
General disorders Pyrexia	12.5% 3/24 • Number of events 3 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Infections and infestations Covid-19	4.2% 1/24 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	8.3% 2/24 • Number of events 2 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Infections and infestations Otitis media	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	4.2% 1/24 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Bilirubin conjugated increased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Blood triglycerides increased	4.2% 1/24 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Mean platelet volume decreased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone development abnormal	0.00% 0/24 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Nervous system disorders Headache	12.5% 3/24 • Number of events 3 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • Number of events 2 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 4/24 • Number of events 4 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	8.3% 2/24 • Number of events 2 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 55 Weeks All participants who received at least one dose of study drug.