Plamotamab injections for adults with moderate to severe rheumatoid arthritis.
A Phase 1b, Open-label, Dose-Escalation Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Plamotamab in Participants With Rheumatoid Arthritis
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 |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Drugs / interventions | plamotamab |
| Locations | 3 sites (Tbilisi and 2 other locations) |
| Trial ID | NCT07230353 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Use of plamotamab in RA is novel with limited prior clinical data, and related bispecific antibody approaches in autoimmune diseases have shown mixed results.
Eligibility criteria
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 this trial is running
Tbilisi and 2 other locations
- Xencor Investigative Site — Tbilisi, Georgia (Recruiting)
- Xencor Investigative Site — Chisinau, Moldova (Recruiting)
- Xencor Investigative Site — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Noriko Iikuni, MD, PhD
- Email: 676-Aiinfo@xencor.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.