RecruitingPhase 1NCT07230353

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

A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis


Sponsor

Xencor, Inc.

Enrollment

47 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

BIOLOGICALXmAb13676

Biological


Locations(4)

Arensia Research Clinic

Tbilisi, Georgia

Xencor Investigative Site

Tbilisi, Georgia

Arensia Research Clinic

Chisinau, Moldova

Xencor Investigative Site

Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07230353


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