Shelby Research

Rheumatoid Arthritis (RA) M25-056 Study

Abbvie clinical trial for Rheumatoid Arthritis (RA)

NOW ENROLLING

This study will evaluate the Efficacy and Safety of targeted therapies through a series of sub-studies, for the treatment of moderately to severely active Rheumatoid Arthritis (RA) and to assess the changes in disease symptoms.

Trial Details

Brief Summary: Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy compared to placebo, Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.

Condition or disease
Rheumatoid Arthritis (RA)

Intervention/treatment
Drug: Lutikizumab
Drug: Ravagalimab
Drug: Placebo

Phase
Phase 2

Inclusion Criteria

  • Participant is 18 years of age or older.

  • At any time prior to the Screening Visit, participant must have been treated for at least 3 months with at least 1 biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.

  • Participant must be on a stable dose of methotrexate (MTX).

    • ***Additional inclusion criteria are defined in the protocol.

Exclusion Criteria

  • Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to 10 mg/day or less of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for at least 1 week prior to the Baseline Visit.

  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

    • ***Other protocol-defined inclusion/exclusion criteria may apply

View Trial on ClinicalTrials.gov website: NCT06972446