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A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)

NCT05063162 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD).

Conditions

  • Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Interventions

DRUG

Rozanolixizumab

* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.

OTHER

Placebo

* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive placebo.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2027-05-06
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT05063162 on ClinicalTrials.gov