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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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 facts

Study ID

NCT06972446

Run by

AbbVie

People needed

180

Starts

2025-06-20

Expected to finish

2027-11-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Willow Rheumatology and Wellness /ID# 272691 — Willowbrook, Illinois, United States (enrolling)
• Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896 — Jonesboro, Arkansas, United States (enrolling)
• Sun Valley Arthritis Center /ID# 278331 — Peoria, Arizona, United States (enrolling)
• Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826 — Chula Vista, California, United States (enrolling)
• Newport Huntington Medical Group /ID# 272439 — Huntington Beach, California, United States (enrolling)
• Cohen Medical Centers /ID# 278341 — Thousand Oaks, California, United States (enrolling)
• The Lundquist Institute /ID# 272481 — Torrance, California, United States (enrolling)
• Private Practice - Dr. David S. Hallegua /ID# 277608 — Beverly Hills, California, United States (enrolling)
• Tekton Research - Fort Collins - East Harmony Road /ID# 272472 — Fort Collins, Colorado, United States (enrolling)
• Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298 — Avon Park, Florida, United States (enrolling)
• Clinical Research Of West Florida - Phase I Unit /ID# 272428 — Clearwater, Florida, United States (enrolling)
• Finlay Medical Research - Greenacres /ID# 281654 — Greenacres City, Florida, United States (enrolling)
• Neoclinical Research - Hialeah /ID# 272070 — Hialeah, Florida, United States (enrolling)
• South Florida Rheumatology /ID# 278339 — Hollywood, Florida, United States (enrolling)
• Swati Shah, MD Rheumatology /ID# 273624 — Jacksonville, Florida, United States (enrolling)
• Life Clinical Trials - Colonial Drive - Margate /ID# 272589 — Margate, Florida, United States (enrolling)
• Inland Rheumatology and Osteoporosis Medical Group /ID# 272449 — Upland, California, United States (enrolling)
• HMD Research LLC /ID# 272432 — Orlando, Florida, United States (enrolling)
• Vitalia Research /ID# 272478 — Palm Beach Gardens, Florida, United States (enrolling)
• Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755 — Tampa, Florida, United States (enrolling)
• Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422 — Chicago, Illinois, United States (enrolling)
• Deerbrook Medical Associates /ID# 273439 — Libertyville, Illinois, United States (enrolling)
• Advanced Quality Medical Research /ID# 277824 — Orland Park, Illinois, United States (enrolling)
• Arnold Arthritis & Rheumatology /ID# 278354 — Skokie, Illinois, United States (enrolling)
• Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650 — Lake Charles, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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