NCT05643794

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2A, Proof-Of-Concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	rozanolixizumab	Study participants will receive rozanolixizumab during the dosing periods as pre-defined.
OTHER	Placebo	Study participants will receive Placebo during the dosing periods as pre-defined.

Timeline

• Start date: 2022-12-21
• Primary completion: 2024-05-28
• Completion: 2024-07-09
• First posted: 2022-12-09
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

7 sites across 1 country: United Kingdom