Plamotamab injections for adults with moderate to severe rheumatoid arthritis.
Official title: A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis
Run by Xencor, Inc. · NCT07230353 · Data updated 2026-11-12
This trial will try subcutaneous plamotamab injections to see if they are safe and tolerated in adults with moderate to severe rheumatoid arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Drugs / interventions | plamotamab |
| Locations | 3 sites (Tbilisi and 2 other locations) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07230353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderately to severely active rheumatoid arthritis who meet 2010 ACR/EULAR criteria and have had inadequate response, loss of response, or intolerance to available RA therapies may qualify.
✕Probably not a fit
Patients with active or recurrent infections, untreated latent tuberculosis, recent major surgery, recent cancer or lymphoproliferative disease, or uncontrolled major organ disease are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1b open-label, dose-escalation trial will enroll about 68 adults with moderately to severely active rheumatoid arthritis who have had inadequate response, loss of response, or intolerance to available therapies. Participants will receive subcutaneous doses of plamotamab (XmAb13676) in assigned dose cohorts with close monitoring for safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The design focuses on dose optimization and identifying adverse events and drug behavior in the blood over time. The trial is unblinded, and participants will attend scheduled clinic visits for injections, laboratory tests, and safety assessments.
Why it matters
Potential benefit: If successful, plamotamab could become a new treatment option for adults with moderately to severely active RA who have not responded well to existing therapies.
How similar studies have gone: Use of plamotamab in RA is novel with limited prior clinical data, and related bispecific antibody approaches in autoimmune diseases have shown mixed results.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Xencor Investigative Site
Tbilisi, Georgia Recruiting -
Xencor Investigative Site
Chisinau, Moldova Recruiting -
Xencor Investigative Site
Auckland, New Zealand Recruiting
Study contacts
- Study coordinator: 676-06 Study Information
- Email: 676-Aiinfo@xencor.com
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.