RO7790121 in Moderate to Severe Rheumatoid Arthritis

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called RO7790121 and its effects on people with moderate to severe rheumatoid arthritis, an autoimmune condition that causes pain, swelling, and stiffness in the joints. RO7790121 is an antibody directed against a protein called TL1A. TL1A is found naturally in the body and may have a role in joint inflammation. Participants will be randomly assigned to 1 of 3 groups. One group will receive a high dose of RO7790121; the second group will receive a low dose of RO7790121; and the third group will receive placebo (inactive substance). Both RO7790121 and placebo will be injected under the skin (subcutaneously).

Eligibility

* 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)

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF RO7790121 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE OR INTOLERANCE TO TNF AND/OR JAK INHIBITORS

Study Details

Disease Type/Condition

Other

Principal Investigator

Giles, Jon

Age Group

Adult

Phase

IRB Number

STUDY00004459

ClinicalTrials.gov ID

NCT07137598

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org