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Afimkibart (RO7790121) for moderate to severe rheumatoid arthritis after TNF or JAK failure

A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

Phase 2 Interventional Hoffmann-La Roche · NCT07137598

This will test whether Afimkibart (RO7790121) works and is safe for people with moderate to severe rheumatoid arthritis who didn't respond to or can't tolerate TNF or JAK inhibitors.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsrituximab
Locations46 sites (Peoria, Arizona and 45 other locations)
Trial IDNCT07137598 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial compares Afimkibart (RO7790121) with placebo in participants who have moderate to severe RA and an inadequate response or intolerance to TNF and/or JAK inhibitors. Eligible participants must have at least >=6 swollen joints and >=6 tender joints, a diagnosis of RA for >=3 months, and prior failure of at least one csDMARD. Key exclusions include prior failure of more than two TNF or JAK inhibitors, Class IV RA, prior use of other bDMARDs (excluding TNF inhibitors) or rituximab, and recent investigational therapy. Study visits take place at several U.S. rheumatology centers and will collect safety and efficacy data versus placebo.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe RA (>=6 swollen and >=6 tender joints), a diagnosis of at least 3 months, and an inadequate response or intolerance to TNF and/or JAK inhibitors after trying at least one csDMARD.

Not a fit: Patients with Class IV RA, those who have failed more than two TNF or JAK inhibitors, or those with prior use of other biologic DMARDs (excluding TNF inhibitors) or rituximab are unlikely to qualify and may not receive benefit from this trial.

Why it matters

Potential benefit: If successful, Afimkibart could offer a new treatment option that reduces joint inflammation and pain for patients who haven't benefited from TNF or JAK inhibitors.

How similar studies have performed: Other targeted biologic and small-molecule therapies have shown benefits in patients with refractory RA, but Afimkibart itself is a newer agent that remains under clinical evaluation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count)
* Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
* Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)

Exclusion Criteria:

* Have failed more than two TNF inhibitors or JAK inhibitors
* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
* Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
* History of organ transplant
* Any identified confirmed congenital or acquired immunodeficiency
* Abnormal laboratory values and liver function test

Where this trial is running

Peoria, Arizona and 45 other locations

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.