Status:
RECRUITING
A Phase 1b Open-label Study to Evaluate Safety in Participants With Rheumatoid Arthritis
Lead Sponsor:
Xencor, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 th...
Detailed Description
This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb13676 in adult participants with moderately to severely activ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT07230353
Start Date
October 21 2025
End Date
June 1 2028
Last Update
November 17 2025
Active Locations (4)
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1
Arensia Research Clinic
Tbilisi, Georgia
2
Xencor Investigative Site
Tbilisi, Georgia
3
Arensia Research Clinic
Chisinau, Moldova
4
Xencor Investigative Site
Auckland, New Zealand