Clinical trial NCT04088409: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uveitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Part A: Percentage of Responders for Baricitinib at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye
timeFrame: Baseline, Week 24
measure: Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)
timeFrame: Baseline, Week 24
measure: Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline
timeFrame: Week 24
measure: Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test
timeFrame: Baseline, Week 24
measure: Change From Baseline in Vitreous Haze
timeFrame: Baseline, Week 24
measure: Change From Baseline in Grade of Flare in the Anterior Chamber
timeFrame: Baseline, Week 24
measure: Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)
timeFrame: Week 24
measure: Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
timeFrame: Baseline through Week 24
measure: Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
timeFrame: Week 24
measure: Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)
timeFrame: Week 24
measure: Change From Baseline in Overall Uveitis-Related Disability
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Hamburg
country: Germany
facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Cambridge Clinical Research Facility
state: Cambridgeshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: England
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: England
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.