A Phase 1b Open-label Study to Evaluate Safety of Plamotamab 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
1 other identifier
interventional
68
3 countries
3
Brief Summary
The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Oct 2025
Longer than P75 for phase_1 rheumatoid-arthritis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2025
CompletedStudy Start
First participant enrolled
October 21, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 14, 2026
April 1, 2026
2.6 years
October 1, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Through Week 52
Secondary Outcomes (1)
Secondary
Through Week 52
Study Arms (1)
Dose Escalation
EXPERIMENTALPlamotamab administered SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
Study Sites (3)
Xencor Investigative Site
Tbilisi, Georgia
Xencor Investigative Site
Chisinau, Moldova
Xencor Investigative Site
Auckland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Osterman, MD, MS
Xencor, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2025
First Posted
November 17, 2025
Study Start
October 21, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04