A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well afimkibart (RO7790121) works and how safe it is compared with a placebo, a treatment with no active drug. It is for people with moderate to severe rheumatoid arthritis (RA), a disease that causes swollen, painful joints, whose TNF or JAK medicines did not help enough or caused side effects they could not tolerate.
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have active, moderate to severe RA, with at least 6 swollen and 6 tender joints at both the screening and starting visits.
- Have had RA for at least 3 months and meet the study’s standard rules for an RA diagnosis.
- Have tried at least one standard disease-modifying RA medicine that did not help enough, stopped helping, or caused side effects you could not tolerate.
Who can't join
- More than two TNF or JAK medicines have failed to help you; or you have ever used rituximab or other biologic RA medicines besides TNF medicines.
- Have Class IV RA, which severely limits daily activities; arthritis that began before age 17; or another current disease that causes joint swelling.
- Used an experimental treatment too recently: within 4 weeks or five drug half-lives, whichever is longer. A half-life is the time it takes the body to clear half a drug. Also excluded: steroid injections into joints, muscles, veins, or areas around joints within 8 weeks before the first study dose.
- Have had a severe allergic reaction or a known allergy to the study drug’s ingredients or similar medicines.
- Had major surgery within 6 weeks before screening, or plan to have major surgery during the study.
- Have a serious, long-term, or unstable medical or mental health condition, or abnormal lab or liver test results.
- Have a history of cancer, except certain fully treated skin cancers that have not spread or cured cervical cancer that stayed where it began.
- Have severe long-term or repeated infections; a history of active hepatitis B, hepatitis C, or HIV; a past organ transplant; or a confirmed condition that weakens the immune system.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (18)
AZ
- Arizona Arthritis & Rheumatology Associates, P.C. · Avondale, AZ 85392More trials in Avondale
- SunValley Arthritis Center Ltd. · Peoria, AZ 85381More trials in Peoria
CA
- University of California Medical Center · La Jolla, CA 92037More trials in La Jolla
- Cedars Sinai Medical Center · Los Angeles, CA 90048More trials in Los Angeles
- Inland Rheumatology Clinical Trials Incorporated · Upland, CA 91786More trials in Upland
FL
- West Broward Rheumatology Associates, Inc. · Tamarac, FL 33321More trials in Tamarac
IL
- Willow Rheumatology and Wellness PLLC · Willowbrook, IL 60527More trials in Willowbrook
KY
- Equity Medical · Owensboro, KY 42303More trials in Owensboro
LA
- Accurate Clinical Research Inc. · Lake Charles, LA 70605More trials in Lake Charles
MI
- Henry Ford Medical Center- New Center One · Detroit, MI 48202More trials in Detroit
NY
- Equity Medical · The Bronx, NY 10455More trials in The Bronx
OH
- Ohio State University Wexner Medical Center · Columbus, OH 43203More trials in Columbus
PA
- Altoona Center For Clinical Research · Duncansville, PA 16635More trials in Duncansville
TX
- Precision Comprehensive Clinical Research Solutions · Colleyville, TX 76034More trials in Colleyville
- Accurate Clinical Management · Houston, TX 77089More trials in Houston
- DM Clinical Research at Tomball · Tomball, TX 77375More trials in Tomball
VA
- Tidewater Clinical Research · Chesapeake, VA 23320More trials in Chesapeake
WI
- Rheumatic Disease Center · Glendale, WI 53217More trials in Glendale