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Looking for participantsPhase2

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)

Sponsor: Hoffmann-La Roche

NCT ID: NCT07137598

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Afimkibart (drug), Placebo (drug)
How long the study runs
Study runs about 22 months (dates as stated)
About the drug or intervention
Afimkibart — drug: Afimkibart will be administered as SC injection. · Placebo — drug: Placebo will be administered as SC injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
160
Started
2025-12-05
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for rheumatoid arthritis
  • • Phase2 - 160 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with rheumatoid arthritis

Where?

  • • Leicester - Leicester Royal Infirmary
  • • Doncaster - Doncaster Royal Infirmary
  • • Newcastle upon Tyne - North Tyneside General Hospital
  • • Barnet - Barnet Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Rheumatoid Arthritis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening...
  • ✓Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance...
  • ✓Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic...

Who cannot take part

  • ✗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...
  • ✗Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy,...
  • ✗History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other...
See the full 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

Where Is This Study? (4 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Doncaster Royal Infirmary

Doncaster DN2 5LT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

North Tyneside General Hospital

Newcastle upon Tyne NE29 8NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk0191 2934087

Barnet Hospital

Barnet EN5 3DJ, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09