Trial record 1 of 1 for:
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
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| ClinicalTrials.gov Identifier: NCT04088409 |
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Recruitment Status :
Recruiting
First Posted : September 12, 2019
Last Update Posted : June 23, 2022
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveitis | Drug: Baricitinib Drug: Adalimumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 16, 2019 |
| Estimated Primary Completion Date : | March 10, 2023 |
| Estimated Study Completion Date : | July 21, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Juvenile idiopathic arthritis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Baricitinib
Baricitinib given orally.
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Drug: Baricitinib
Administered orally
Other Name: LY3009104 |
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Active Comparator: Adalimumab
Adalimumab given subcutaneously (SC).
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Drug: Adalimumab
Administered SC |
Primary Outcome Measures :
- Percentage of Responders [ Time Frame: Week 24 ]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 [ Time Frame: Baseline, 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 Less Severely Affected Eye (If Applicable) [ 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)
- Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline [ Time Frame: 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.
- Change from Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test [ Time Frame: Baseline, Week 24 ]Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test
- Change from Baseline in Vitreous Haze [ Time Frame: Baseline, Week 24 ]Change from Baseline in Vitreous Haze
- Change from Baseline in Grade of Flare in the Anterior Chamber [ Time Frame: Baseline, Week 24 ]Change from Baseline in Grade of Flare in the Anterior Chamber
- Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition) [ Time Frame: Week 24 ]Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)
- Time to Inactive Anterior Uveitis Disease (Using SUN Definition) [ Time Frame: Baseline through Week 24 ]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 [ Time Frame: Week 24 ]Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
- Time to Treatment Response [ Time Frame: Baseline through Week 24 ]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) [ Time Frame: Week 24 ]PediACR30 Response Rate (For Participants with JIA-U)
- Change from Baseline in Overall Uveitis-Related Disability [ Time Frame: Baseline, Week 24 ]Change from Baseline in Overall Uveitis-Related Disability
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| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088409
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | Clinicaltrials.gov@lilly.com |
Locations
Show 23 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT04088409 |
| Other Study ID Numbers: |
16277 I4V-MC-JAHW ( Other Identifier: Eli Lilly and Company ) 2019-000119-10 ( EudraCT Number ) |
| First Posted: | September 12, 2019 Key Record Dates |
| Last Update Posted: | June 23, 2022 |
| Last Verified: | June 17, 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| 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. |
| URL: | http://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Uveitis Uveal Diseases Eye Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |