A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)

Trial Information
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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 (MOG-AD).

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Maximum Age:
89
Healthy Volunteers:
No

• Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent

• Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations:

• Optic neuritis (single, recurrent, or simultaneous bilateral)

• Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM))

• Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis

• Combined presentations

• Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening

• Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months prior to randomization

• Participant must be clinically stable at the time of the Screening Visit and during the Screening Period

Where is this trial taking place?
United States
California
Mog001 50450
Recruiting
Palo Alto
Colorado
Mog001 50101
Recruiting
Aurora
Illinois
Mog001 50472
Recruiting
Peoria
Kansas
Mog001 50074
Recruiting
Kansas City
Massachusetts
Mog001 50243
Recruiting
Boston
Other Locations
Belgium
Mog001 40185
Recruiting
Gent
France
Mog001 40422
Recruiting
Caen
Mog001 40170
Recruiting
Strasbourg
Germany
Mog001 40659
Recruiting
Berlin
Japan
8 locations
Mog001 20225
Recruiting
Bunkyo-ku
Mog001 20068
Recruiting
Chiba-shi
Mog001 20143
Recruiting
Kodaira
Mog001 20223
Recruiting
Koriyama
Mog001 20224
Recruiting
Sendai
Mog001 20227
Recruiting
Sendai
Mog001 20070
Recruiting
Shinjuku-ku
Mog001 20032
Recruiting
Suita
Republic of Korea
Mog001 20226
Recruiting
Goyang-si
Mog001 20104
Recruiting
Seoul
Spain
Mog001 40267
Recruiting
Barcelona
Mog001 40100
Recruiting
Madrid
Switzerland
Mog001 40337
Recruiting
Bern
Turkey
Mog001 40550
Recruiting
İ̇stanbul
Mog001 40648
Recruiting
Samsun
Who do I contact about this trial?
Primary
UCB Cares
UCBCares@ucb.com
+1844599
When is this trial taking place?
Start Date: February 2, 2022
Estimated Completion Date: July 23, 2025
How many participants will be in this trial?
Target number of participants: 104
What treatment is being studied in this trial?
Experimental: Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
Placebo Comparator: Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov