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)

Status: Recruiting
Location: See all (69) 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

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

• Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD

• Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization

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

Locations
United States
Arizona
Mog001 50297
RECRUITING
Scottsdale
California
Mog001 50450
RECRUITING
Palo Alto
Colorado
Mog001 50101
RECRUITING
Aurora
Washington, D.c.
Mog001 50553
RECRUITING
Washington
Florida
Mog001 50342
RECRUITING
Jacksonville
Mog001 50308
RECRUITING
Tampa
Illinois
Mog001 50472
RECRUITING
Peoria
Kansas
Mog001 50074
RECRUITING
Kansas City
Massachusetts
Mog001 50243
RECRUITING
Boston
Maryland
Mog001 50552
RECRUITING
Baltimore
Minnesota
Mog001 50104
RECRUITING
Rochester
Ohio
Mog001 50571
RECRUITING
Cleveland
Texas
Mog001 50568
RECRUITING
San Antonio
Utah
Mog001 50473
RECRUITING
Salt Lake City
Other Locations
Australia
Mog001 30022
RECRUITING
Melbourne
Mog001 30026
WITHDRAWN
Southport
Belgium
Mog001 40122
RECRUITING
Edegem
Mog001 40185
RECRUITING
Gent
Brazil
Mog001 60033
RECRUITING
Porto Alegre
France
Mog001 40657
RECRUITING
Bron Cedex
Mog001 40422
RECRUITING
Caen
Mog001 40130
RECRUITING
Marseille
Mog001 40755
RECRUITING
Montpellier
Mog001 40170
RECRUITING
Strasbourg
Germany
Mog001 40659
RECRUITING
Berlin
Mog001 40140
RECRUITING
Göttingen
Mog001 40577
RECRUITING
Ulm
Italy
Mog001 40146
RECRUITING
Pavia
Mog001 40629
RECRUITING
Roma
Mog001 40646
RECRUITING
Verona
Japan
Mog001 20225
RECRUITING
Bunkyo-ku
Mog001 20068
RECRUITING
Chiba-shi
Mog001 20307
RECRUITING
Isehara
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
Mexico
Mog001 50485
RECRUITING
Ciudad Juárez
Mog001 50486
RECRUITING
Culiacán
Portugal
Mog001 40485
RECRUITING
Coimbra
Mog001 40669
RECRUITING
Porto
Republic of Korea
Mog001 20226
RECRUITING
Goyang-si
Mog001 20104
RECRUITING
Seoul
Spain
Mog001 40267
RECRUITING
Barcelona
Mog001 40100
RECRUITING
Madrid
Mog001 40161
RECRUITING
Madrid
Mog001 40341
RECRUITING
Málaga
Mog001 40350
RECRUITING
Murcia
Mog001 40049
RECRUITING
Sevilla
Sweden
Mog001 40660
RECRUITING
Gothenburg
Mog001 40663
RECRUITING
Huddinge
Switzerland
Mog001 40723
RECRUITING
Basel
Mog001 40337
RECRUITING
Bern
Taiwan
Mog001 20096
RECRUITING
Changhua County,changhua City
Mog001 20303
RECRUITING
Kaohsuing City
Mog001 20080
RECRUITING
Taichung City
Mog001 20094
RECRUITING
Tainan City
Mog001 20304
RECRUITING
Taipei City
Mog001 20082
RECRUITING
Taoyuan City
Turkey
Mog001 40550
RECRUITING
İ̇stanbul
Mog001 40726
RECRUITING
Izmir
Mog001 40648
RECRUITING
Samsun
Mog001 40725
RECRUITING
Sancaktepe
Ukraine
Mog001 20319
RECRUITING
Kyiv
Mog001 20228
RECRUITING
Ternopil
United Kingdom
Mog001 40661
RECRUITING
Liverpool
Mog001 40163
RECRUITING
Oxford
Contact Information
Primary
UCB Cares
UCBCares@ucb.com
1-844-599-2273 (USA)
Backup
UCB Cares
UCBCares@ucb.com
001 844 599 2273
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 104
Treatments
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.
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov

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