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

Uveitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04088409
• Other study ID #: 16277
• Secondary ID: I4V-MC-JAHW2019-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 16, 2019
• Est. completion date: July 21, 2028

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 21, 2028
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Baricitinib
Administered orally
• Adalimumab
Administered SC

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Femme Mère Enfant	Bron	Rhône-Alpes
France	Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre	Le Kremlin Bicetre
France	Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard
France	Hôpital Universitaire Necker Enfants Malades	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers Cedex
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari	Hamburg
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin	Nordrhein-Westfalen
Italy	Azienda Ospedaliero Universitaria Meyer	Firenze
Italy	IRCCS Istituto Giannina Gaslini	Genova	Liguria
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona
Spain	Hospital Infantil Universitario Niño Jesús	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario La Paz	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario La Fe de Valencia	Valencia
United Kingdom	Bristol Royal Hospital for Children	Bristol	Bristol, City Of
United Kingdom	Cambridge Clinical Research Facility	Cambridge	Cambridgeshire
United Kingdom	Alder Hey Children's Hospital	Liverpool	England
United Kingdom	Great Ormond Street Hospital For Children NHS Foundation Trust	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne	England
United Kingdom	Sheffield Children's Hospital	Sheffield
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Responders	Response is 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.	Week 24
Secondary	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	Baseline, Week 24
Secondary	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)	Baseline, Week 24
Secondary	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.	Week 24
Secondary	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	Baseline, Week 24
Secondary	Change from Baseline in Vitreous Haze	Change from Baseline in Vitreous Haze	Baseline, Week 24
Secondary	Change from Baseline in Grade of Flare in the Anterior Chamber	Change from Baseline in Grade of Flare in the Anterior Chamber	Baseline, Week 24
Secondary	Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)	Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)	Week 24
Secondary	Time to Inactive Anterior Uveitis Disease (Using SUN Definition)	Time to Inactive Anterior Uveitis Disease (Using SUN Definition)	Baseline through Week 24
Secondary	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	Week 24
Secondary	Time to Treatment Response	Response is defined by a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero in the most severely affected eye at baseline	Baseline through Week 24
Secondary	PediACR30 Response Rate (For Participants with JIA-U)	PediACR30 Response Rate (For Participants with JIA-U)	Week 24
Secondary	Change from Baseline in Overall Uveitis-Related Disability	Change from Baseline in Overall Uveitis-Related Disability	Baseline, Week 24

External Links

•   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