drugset / Trial / NCT05643794

A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

NCT05643794 ↗

Phase 2 Completed 63 enrolled UCB Biopharma SRL
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).

Timeline

Start
2022-12-21
Primary completion
2024-05-28
Completion
2024-07-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo (PBO) vs RLZ 12 Weeks; p = 0.129 NCT05643794 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rozanolixizumab Monoclonal antibody — —

Indications