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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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) (NCT07137598) is a Phase 2 interventional studying Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rheumatoid Arthritis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Afimkibart

Afimkibart will be administered as SC injection.

DRUG

Placebo

Placebo will be administered as SC injection.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SunValley Arthritis Center Ltd.
Peoria, Arizona, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Accurate Clinical Management
Houston, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Tidewater Clinical Research
Chesapeake, Virginia, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Centro Medico Arsema
Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, Argentina
HUB Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07137598), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07137598 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07137598?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07137598?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07137598. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07137598. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.