Phase 1b Open-label Trial to Assess Safety and Effects of Plamotamab Injection in Adults With Moderate to Severe Rheumatoid Arthritis

What this Trial Is About

Researchers are evaluating the safety and tolerability of plamotamab in adults with moderately to severely active rheumatoid arthritis RA. This Phase 1b open-label study also assesses how the body processes plamotamab pharmacokinetics and its effects on the immune system pharmacodynamics and immunogenicity. The study is designed as an open-label dose optimization trial involving around 68 participants assigned to different dose escalation groups. Participants will receive plamotamab through subcutaneous injections under the skin. The study focuses on escalating doses to find the optimal safe and tolerable dose. The treatment phase includes continuous monitoring of participants during the dosing period, which extends through Week 52. This is a single-group study without a placebo or comparator. Throughout the study, participants will undergo regular safety and tolerability assessments, including laboratory tests and monitoring of immune responses. Researchers will evaluate primary and secondary outcomes through Week 52 to understand plamotamabs effects. Participants are expected to maintain stable doses of their RA medications and use effective contraception during the trial. The total participation duration covers treatment and follow-up up to one year.

A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis