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

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What is being tested

Afimkibart

+ Placebo
Drug
Who is being recruted

Rheumatoid Arthritis

Over 18 Years
+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: WA45846 https://forpatients.roche.com/
Last updated: October 10, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 9, 2025Actual 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 
Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: WA45846 https://forpatients.roche.com/
Last updated: October 10, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Rheumatoid Arthritis
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

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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 no location dataSave this study to your profile to know when the location data is available. 
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