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Targeted treatment with lutikizumab and ravagalimab for rheumatoid arthritis

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

Phase 2 Interventional AbbVie · NCT06972446

This Phase 2 trial will test whether lutikizumab, ravagalimab, or their combination reduce symptoms in people with moderately to severely active rheumatoid arthritis who have failed 1–2 prior biologic or targeted therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsmethotrexate, prednisone, lutikizumab, ravagalimab
Locations71 sites (Peoria, Arizona and 70 other locations)
Trial IDNCT06972446 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with moderately to severely active RA who have failed 1–2 prior b/tsDMARDs and are on a stable dose of methotrexate would be the ideal candidates.

Not a fit: Patients who have not tried at least one biologic/targeted therapy, who have other inflammatory joint diseases or childhood-onset arthritis, or who cannot maintain stable concomitant medications are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, these targeted therapies could provide an additional treatment option for patients with RA who did not respond to prior biologic or targeted medications.

How similar studies have performed: Other targeted biologic and small-molecule therapies (for example TNF, IL-6, and JAK inhibitors) have improved RA, but lutikizumab and ravagalimab use different mechanisms and have limited prior clinical data in RA.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Peoria, Arizona and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rheumatoid Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.