Actively Recruiting
A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis
Led by Xencor, Inc. · Updated on 2026-04-14
68
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of plamotamab in adults with moderately to severely active rheumatoid arthritis. This Phase 1b open-label study also looks at how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and the immune response it may trigger. Approximately 68 participants will take part, divided into groups receiving different doses to find the optimal amount. Participants will receive plamotamab through subcutaneous injections, meaning the drug is given under the skin. This dose-escalation trial involves increasing doses over time to monitor safety and tolerability at each level. The study is open-label, so both participants and researchers know the treatment being given. Throughout the study, which lasts up to 52 weeks, participants will undergo various assessments to monitor safety, drug levels, immune response, and tolerability. Researchers will track how participants respond to treatment, including any side effects or changes in disease activity. This thorough monitoring helps understand the drug’s profile over time in rheumatoid arthritis patients.
CONDITIONS
Brief Title
A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants with moderately to severely active rheumatoid arthritis
- Documented diagnosis of rheumatoid arthritis meeting 2010 classification criteria at least 3 months before screening
- Inadequate response to, loss of response to, or intolerance to available rheumatoid arthritis therapies
- Stable doses of rheumatoid arthritis medications before screening
- Use of highly effective contraception methods
You will not qualify if you...
- Major surgery within 12 weeks before 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 past 5 years
- Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive plamotamab administered subcutaneously as part of dose-escalation to evaluate safety and tolerability.
Trial Site Locations
Total: 3 locations
1
Xencor Investigative Site
Tbilisi, Georgia
Actively Recruiting
2
Xencor Investigative Site
Chisinau, Moldova
Actively Recruiting
3
Xencor Investigative Site
Auckland, New Zealand
Actively Recruiting
Research Team
N
Noriko Iikuni, MD, PhD
J
Jaime Mertz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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