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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lutikizumab — DRUG
  Subcutaneous (SC) injection
• Placebo — DRUG
  Subcutaneous (SC) injection
• Ravagalimab — DRUG
  Subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date

Jun 20, 2025

Status verified

Jun 2026

Primary completion

Feb 28, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Substudy 1: Lutikizumab Monotherapy
  Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B
• Placebo Comparator: Substudy 1: Matching Placebo Monotherapy
  Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.
• Experimental: Substudy 2: Ravagalimab Monotherapy
  Participants will be randomized to receive Ravagalimab
• Placebo Comparator: Substudy 2: Matching Placebo Monotherapy
  Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy
• Experimental: SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy
  Participants will be randomized to be administered Lutikizumab and Ravagalimab doses
• Placebo Comparator: Substudy 3: Matching Placebo Combination Therapy
  Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: At Week 12 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (52)

Find similar trials in Peoria, AZ

Related Studies

• Physica System Total Knee Replacement Registry Study
  Recruiting · Limacorporate S.p.a · Rancho Mirage, California
• Maternal Autoimmune Disease Research Alliance (MADRA) Registry
  Recruiting · Duke University · Durham, North Carolina
• Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
  Recruiting · University of Colorado, Denver · Aurora, Colorado
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama