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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Arthritis & Rheumatology Associates, P.C.
  Avondale, Arizona, United States Recruiting
• SunValley Arthritis Center Ltd.
  Peoria, Arizona, United States Recruiting
• University of California Medical Center
  La Jolla, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Inland Rheumatology Clinical Trials Incorporated
  Upland, California, United States Recruiting
• West Broward Rheumatology Associates, Inc.
  Tamarac, Florida, United States Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
• Email: global.rochegenentechtrials@roche.com
• Phone: 888-662-6728 (U.S. and Canada)

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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.