A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

NCT04650854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-04-18

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

Conditions

Interventions

DRUG

Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 22733 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2024-01-25
Completion
2024-01-25
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • France
  • Georgia
  • Germany
  • Italy
  • Japan
  • Poland
  • Russia
  • Serbia
  • Spain
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04650854 on ClinicalTrials.gov