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A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis
NCT07230353 · Xencor, Inc.
In plain English
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Official title
A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis
About this study
This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of plamotamab in adult participants with moderately to severely active RA. This is an open label dose optimization trial with approximately 68 participants assigned to different dose escalation cohorts.
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.
Study design
Enrollment target: 68 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-21
Estimated completion: 2028-06
Last updated: 2026-04-14
Interventions
Biological: Plamotamab
Primary outcomes
- • Primary (Through Week 52)
Sponsor
Xencor, Inc. · industry
Contacts & investigators
ContactNoriko Iikuni, MD, PhD · contact · 676-Aiinfo@xencor.com
ContactJaime Mertz · contact · 676-Aiinfo@xencor.com
InvestigatorMark Osterman, MD, MS · study_director, Xencor, Inc.
All locations (3)
Xencor Investigative SiteRecruiting
Tbilisi, Georgia
Xencor Investigative SiteRecruiting
Chisinau, Moldova
Xencor Investigative SiteRecruiting
Auckland, New Zealand