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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

Primary Purpose

Uveitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Adalimumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
  • GH Necker - Enfants Malades
  • CHU Poitiers - Hopital Jean Bernard
  • Asklepios Klinik Sankt Augustin
  • HELIOS Klinikum Berlin-Buch
  • Charité Campus Virchow-Klinikum
  • Hamburger Zentrum für Kinder und Jugendrheumatologie
  • Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero Universitaria Meyer
  • Hospital Sant Joan de Déu
  • Hospital Infantil Universitario Niño Jesús
  • Hospital Universitario La Paz
  • Hospital Universitario La Fe de Valencia
  • Bristol Royal Hospital for Children
  • Cambridge Clinical Research Facility
  • Alder Hey Children's Hospital
  • Royal Victoria Infirmary
  • University Hospital Southampton NHS Foundation Trust
  • Great Ormond Street Hospital For Children NHS Foundation Trust
  • Sheffield Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baricitinib

Adalimumab

Arm Description

Baricitinib given orally.

Adalimumab given subcutaneously (SC).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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.
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
Change from Baseline in Vitreous Haze
Change from Baseline in Vitreous Haze
Change from Baseline in Grade of Flare in the Anterior Chamber
Change from Baseline in Grade of Flare in the Anterior Chamber
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
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
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
PediACR30 Response Rate (For Participants with JIA-U)
PediACR30 Response Rate (For Participants with JIA-U)
Change from Baseline in Overall Uveitis-Related Disability
Change from Baseline in Overall Uveitis-Related Disability

Full Information

First Posted
September 11, 2019
Last Updated
April 16, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04088409
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
Baricitinib given orally.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Adalimumab given subcutaneously (SC).
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Responders
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye
Description
Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye
Time Frame
Baseline, Week 24
Title
Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)
Description
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
Title
Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline
Description
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.
Time Frame
Week 24
Title
Change from Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test
Description
Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test
Time Frame
Baseline, Week 24
Title
Change from Baseline in Vitreous Haze
Description
Change from Baseline in Vitreous Haze
Time Frame
Baseline, Week 24
Title
Change from Baseline in Grade of Flare in the Anterior Chamber
Description
Change from Baseline in Grade of Flare in the Anterior Chamber
Time Frame
Baseline, Week 24
Title
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)
Description
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)
Time Frame
Week 24
Title
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
Description
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
Time Frame
Baseline through Week 24
Title
Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
Description
Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
Time Frame
Week 24
Title
Time to Treatment Response
Description
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
Time Frame
Baseline through Week 24
Title
PediACR30 Response Rate (For Participants with JIA-U)
Description
PediACR30 Response Rate (For Participants with JIA-U)
Time Frame
Week 24
Title
Change from Baseline in Overall Uveitis-Related Disability
Description
Change from Baseline in Overall Uveitis-Related Disability
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
City
Bron
State/Province
Rhône-Alpes
ZIP/Postal Code
69500
Country
France
Facility Name
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
GH Necker - Enfants Malades
City
Paris Cedex 15
ZIP/Postal Code
75743
Country
France
Facility Name
CHU Poitiers - Hopital Jean Bernard
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Asklepios Klinik Sankt Augustin
City
Saint Augustin
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53757
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Hamburger Zentrum für Kinder und Jugendrheumatologie
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Cambridge Clinical Research Facility
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0SP
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Great Ormond Street Hospital For Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
34627340
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5MwLoOOn4GIPFAxy1iilv6
Description
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

Learn more about this trial

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

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