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)

Autoimmune Disorder
Rheumatoid Arthritis

For Medical Professional
Download

Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Trial Identifier NCT07137598, WA45846

Condition Rheumatoid Arthritis

Official Title 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

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

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)

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

Link to Third Party Site

The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Request a call back

First Name

Last Name

lblFpPhoneNumber

Products

When can we call you? (Free Service) 5am to 9am PST 9am to 1pm PST 1pm to 5pm PST

Don't want to wait for a callback ? Call us now

For Visitors from United States, our Privacy Statement can be reviewed below:
https://www.gene.com/privacy-policy

For Visitors from Canada, our Privacy Statement can be reviewed below:

http://www.rochecanada.com/en/content/footer-items/privacy.html

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)

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

YOU ARE ABOUT TO LEAVE THE GENENTECH CLINICAL TRIALS WEBSITE

Link to Third Party Site

Contact Genentech

Contact the hospital directly

Thank you

Request a call back

Find participating medical centers and current study status in each of them

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)

For the latest version of this information please go to www.forpatients.roche.com