A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Study Identifier
M25-056
CT.gov Identifier
NCT06972446
EudraCT Identifier
Not available
EUCTIS ID
2025-520721-21-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • Lutikizumab
  • Placebo
  • Ravagalimab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 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)
    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 of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit. * History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

    Protocol Summary

    Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).

    This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.

    There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Sun Valley Arthritis Center /ID# 278331
    Peoria, Arizona, United States, 85381
    Status
    Recruiting
    Location
    Arensia Research Clinic /ID# 280896
    Phoenix, Arizona, United States, 85015
    Status
    Not yet recruiting
    Location
    Private Practice - Dr. David S. Hallegua /ID# 277608
    Beverly Hills, California, United States, 90211
    Status
    Recruiting
    Location
    Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
    Chula Vista, California, United States, 91910
    Status
    Recruiting
    Location
    Newport Huntington Medical Group /ID# 272439
    Huntington Beach, California, United States, 92648-5994
    Status
    Recruiting
    Location
    Cohen Medical Centers /ID# 278341
    Thousand Oaks, California, United States, 91360
    Status
    Recruiting
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