Targeted treatment with lutikizumab and ravagalimab for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled program includes three substudies testing lutikizumab alone, ravagalimab alone, and the two drugs combined in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1–2 prior biologic/targeted synthetic DMARDs. Approximately 180 participants will be enrolled across about 65 sites worldwide and will remain on stable methotrexate while receiving study treatment or placebo. Each substudy compares the active drug(s) to placebo to measure safety and efficacy endpoints over the treatment period. The protocol excludes people with other inflammatory joint diseases or childhood-onset arthritis and may require frequent clinic visits and monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Valley Arthritis Center /ID# 278331
  Peoria, Arizona, United States Recruiting
• Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896
  Jonesboro, Arkansas, United States Recruiting
• Private Practice - Dr. David S. Hallegua /ID# 277608
  Beverly Hills, California, United States Recruiting
• Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
  Chula Vista, California, United States Recruiting
• Newport Huntington Medical Group /ID# 272439
  Huntington Beach, California, United States Recruiting
• Cohen Medical Centers /ID# 278341
  Thousand Oaks, California, United States Recruiting

+46 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.