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

Last updated: July 14, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Joint Injuries

Rheumatoid Arthritis

Treatment

Lutikizumab

Placebo

Ravagalimab

Clinical Study ID

NCT06972446
M25-056
2025-520721-21-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 treatmentduration. The maximum cap for prior use of b/tsDMARD is 2.

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

Exclusion

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 conditionsunless 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 ofinflammatory joint disease other than rheumatoid arthritis.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Lutikizumab
Phase: 2
Study Start date:
June 20, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Tekton Research - Fort Collins - East Harmony Road /ID# 272472

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Phase I Unit /ID# 272428

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Life Clinical Trials /ID# 272589

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • AA Medical Research Center - Grand Blanc /ID# 272496

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Albuquerque Center For Rheumatology /ID# 272301

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Paramount Medical Research and Consulting /ID# 272474

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Tekton Research - West Gate /ID# 272270

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Private Practice - Dr. Laila A. Hassan /ID# 272297

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Dynamed Clinical Research - Tomball /ID# 272452

    Tomball, Texas 77375
    United States

    Active - Recruiting

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