Recruiting

Afimkibart for Moderate to Severe Rheumatoid Arthritis with TNF/JAK Inhibitor Intolerance

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Afimkibart

+ Placebo

Drug
Who is being recruted

Arthritis+6

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: WA45846 https://forpatients.roche.com/
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 5, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating how effective and safe a drug called Afimkibart (RO7790121) is for people suffering from moderate to severe rheumatoid arthritis. These individuals have not had satisfactory results or cannot tolerate treatment with TNF and/or JAK inhibitors, which are common medications for managing this condition. The study is important because it aims to find an alternative treatment option for those who have limited or no benefit from existing therapies, potentially improving their quality of life. Participants in the study will receive either Afimkibart or a placebo, which is a substance with no active medication, to compare the effects. The treatment will be administered under controlled conditions, and researchers will closely monitor participants to determine how well the drug works in reducing symptoms of rheumatoid arthritis and to check for any side effects. Although no specific primary outcomes are listed, the study's main focus is on assessing both the effectiveness and safety of Afimkibart.

Official TitleA 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 
NCT07137598
Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: WA45846 https://forpatients.roche.com/
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

3 inclusion criteria required to participate
Has moderate to severe active RA defined by the presence of >= 6 swollen joints and >= 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)
15 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive afimkibart via subcutaneous (SC) injection.

Group II

Experimental
Participants will receive afimkibart via SC injection.

Group III

Placebo
Participants will receive afimkibart matched placebo via SC injection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

SunValley Arthritis Center Ltd.

Peoria, United StatesSee the location
Recruiting

Inland Rheumatology Clinical Trials Incorporated

Upland, United States
Recruiting

West Broward Rheumatology Associates, Inc.

Tamarac, United States
Recruiting

Altoona Center For Clinical Research

Duncansville, United States
Recruiting
7 Study Centers