NCT06972446

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

A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Lutikizumab	Subcutaneous (SC) injection
DRUG	Placebo	Subcutaneous (SC) injection
DRUG	Ravagalimab	Subcutaneous (SC) injection

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-02-01
• Completion: 2027-11-01
• First posted: 2025-05-15
• Last updated: 2026-04-14

Locations

70 sites across 10 countries: United States, Canada, Czechia, Germany, Hungary, Poland, Puerto Rico, Slovakia, South Korea, Spain

Regulatory

• FDA-regulated drug study