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Recruiting Phase 1 NCT07230353

A Phase 1b Open-label Study to Evaluate Safety in Participants With Rheumatoid Arthritis

Trial Parameters

Condition Rheumatoid Arthritis
Sponsor Xencor, Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 47
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-21
Completion 2028-06
Interventions
XmAb13676

Brief Summary

The purpose of this study is to determine the safety and tolerability of XmAb13676 in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.

Eligibility Criteria

Inclusion Criteria: Adult participants with moderately to severely active RA. * Documented diagnosis of RA and meeting the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening * Inadequate response to, loss of response to, or intolerance to available RA therapies. * Stable doses of RA medications prior to screening * Use of highly effective methods of contraception Exclusion Criteria: * Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * Recurrent infections or active clinically significant infection * Active or untreated latent tuberculosis * Cancer or history of cancer or lymphoproliferative disease within the previous 5 years * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.

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