Baricitinib for Uveitis | Juvenile idiopathic arthritis-associated uveitis | Chronic anterior antinuclear antibody-positive uveitis

Inclusion criteria

• {"criterion_text":"- Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Participants must have an inadequate response or intolerance to MTX."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis."}
• {"criterion_text":"- Participants must not have any contraindications to adalimumab."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy)."}
• {"criterion_text":"- Participants must not have a current or recent (<4 weeks prior to baseline) infection."}
• {"criterion_text":"- Participants must not have a positive test for hepatitis B virus (HBV) at screening."}
• {"criterion_text":"- Participants must not have evidence of active tuberculosis (TB) or untreated latent TB."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Response defined per SUN criteria: a 2-step decrease in anterior chamber cells or decrease to zero through week 24 in the eye most severely affected at baseline; measured by anterior chamber cell grade according to SUN criteria up to week 24."}

Methods

• Recruitment materials: K2_Recruitment material_Poster (document listed as recruitment arrangement).
• Patient recruitment support provided by Publicis Healthcare Communications Group Limited (duty listed as 'Patient Recruitment' in third parties).

Italy

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

04-06-2024

Processing Time Days

119

Number Of Sites

1

Number Of Participants

4

Germany

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

05-06-2024

Processing Time Days

120

Number Of Sites

3

Number Of Participants

10

Spain

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

423

Number Of Sites

3

Number Of Participants

5

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

code:6

Name

Iqvia Rds Inc.

Responsibilities

code:1

Name

Quintiles Laboratories Europe

Responsibilities

code:4

Name

Bioclinica Inc.

Responsibilities

code:4

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Quintiles Laboratories Europe","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Macrostat (Shanghai) Clinical Research Co. Ltd.","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}