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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rozanolixizumab | Monoclonal antibody | — | — |