Clinical trial NCT05063162: A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)
Keywords: MOG
MOGAD
Rozanolixizumab
Myelin oligodendrocyte glycoprotein
Myelin oligodendrocyte glycoprotein antibody-associated disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
* Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
* Participant has a current or medical history of primary immunodeficiency
* Participant tests positive for aquaporin-4 antibodies at Screening
* Participant has a serum total IgG level ≤ 5.5g/L

Primary outcomes:
measure: For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
timeFrame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
measure: For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
timeFrame: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
measure: For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
timeFrame: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
Secondary outcomes:
measure: For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit
timeFrame: From Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
measure: For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
timeFrame: Baseline (Week 1), EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
measure: For Part A: Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period
timeFrame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
measure: For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
timeFrame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)
measure: For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
timeFrame: Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mog001 50297
state: Arizona
city: Palo Alto
country: United States
facility: Mog001 50450
state: California
city: Aurora
country: United States
facility: Mog001 50101
state: Colorado
city: Washington
country: United States
facility: Mog001 50553
state: District of Columbia
city: Jacksonville
country: United States
facility: Mog001 50342
state: Florida
city: Tampa
country: United States
facility: Mog001 50308
state: Florida
city: Peoria
country: United States
facility: Mog001 50472
state: Illinois
city: Kansas City
country: United States
facility: Mog001 50074
state: Kansas
city: Baltimore
country: United States
facility: Mog001 50552
state: Maryland
city: Boston
country: United States
facility: Mog001 50243
state: Massachusetts
city: Rochester
country: United States
facility: Mog001 50104
state: Minnesota
city: Cleveland
country: United States
facility: Mog001 50571
state: Ohio
city: Dallas
country: United States
facility: Mog001 50304
state: Texas
city: San Antonio
country: United States
facility: Mog001 50568
state: Texas
city: Salt Lake City
country: United States
facility: Mog001 50473
state: Utah
city: Melbourne
country: Australia
facility: Mog001 30022
city: Southport
country: Australia
facility: Mog001 30026
city: Anderlecht
country: Belgium
facility: Mog001 40123
city: Bruxelles/brussel
country: Belgium
facility: Mog001 40756
city: Edegem
country: Belgium
facility: Mog001 40122
city: Gent
country: Belgium
facility: Mog001 40185
city: Porto Alegre
country: Brazil
facility: Mog001 60033
city: Hradec Kralove
country: Czechia
facility: Mog001 40195
city: Praha 2
country: Czechia
facility: Mog001 40124
city: Teplice
country: Czechia
facility: Mog001 40721
city: Bron Cedex
country: France
facility: Mog001 40657
city: Caen
country: France
facility: Mog001 40422
city: Marseille
country: France
facility: Mog001 40130
city: Montpellier
country: France
facility: Mog001 40755
city: Strasbourg
country: France
facility: Mog001 40170
city: Berlin
country: Germany
facility: Mog001 40659
city: Göttingen
country: Germany
facility: Mog001 40140
city: Münster
country: Germany
facility: Mog001 40177
city: ULM
country: Germany
facility: Mog001 40577
city: Pavia
country: Italy
facility: Mog001 40146
city: Roma
country: Italy
facility: Mog001 40629
city: Verona
country: Italy
facility: Mog001 40646
city: Bunkyo-ku
country: Japan
facility: Mog001 20225
city: Chiba-shi
country: Japan
facility: Mog001 20068
city: Isehara
country: Japan
facility: Mog001 20307
city: Kodaira
country: Japan
facility: Mog001 20143
city: Koriyama
country: Japan
facility: Mog001 20223
city: Sendai
country: Japan
facility: Mog001 20224
city: Sendai
country: Japan
facility: Mog001 20227
city: Shinjuku-ku
country: Japan
facility: Mog001 20070
city: Suita
country: Japan
facility: Mog001 20032
city: Goyang-si
country: Korea, Republic of
facility: Mog001 20226
city: Seoul
country: Korea, Republic of
facility: Mog001 20104
city: Ciudad de Mexico
country: Mexico
facility: Mog001 50485
city: Culiacán
country: Mexico
facility: Mog001 50486
city: Coimbra
country: Portugal
facility: Mog001 40485
city: Porto
country: Portugal
facility: Mog001 40669
city: Barcelona
country: Spain
facility: Mog001 40267
city: Madrid
country: Spain
facility: Mog001 40100
city: Madrid
country: Spain
facility: Mog001 40161
city: Murcia
country: Spain
facility: Mog001 40350
city: Málaga
country: Spain
facility: Mog001 40341
city: Sevilla
country: Spain
facility: Mog001 40049
city: Gothenburg
country: Sweden
facility: Mog001 40660
city: Huddinge
country: Sweden
facility: Mog001 40663
city: Basel
country: Switzerland
facility: Mog001 40723
city: Bern
country: Switzerland
facility: Mog001 40337
city: Zurich
country: Switzerland
facility: Mog001 40630
city: Changhua City
country: Taiwan
facility: Mog001 20096
city: Kaohsuing CITY
country: Taiwan
facility: Mog001 20303
city: Taichung
country: Taiwan
facility: Mog001 20080
city: Tainan
country: Taiwan
facility: Mog001 20094
city: Taipei
country: Taiwan
facility: Mog001 20304
city: Taiyuan CITY
country: Taiwan
facility: Mog001 20082
city: Izmir
country: Turkey
facility: Mog001 40726
city: İ̇stanbul
country: Turkey
facility: Mog001 40550
city: Samsun
country: Turkey
facility: Mog001 40648
city: Sancaktepe
country: Turkey
facility: Mog001 40725
city: Kyiv
country: Ukraine
facility: Mog001 20319
city: Ternopil
country: Ukraine
facility: Mog001 20228
city: Liverpool
country: United Kingdom
facility: Mog001 40661
city: Oxford
country: United Kingdom
facility: Mog001 40163
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Mader S, Kumpfel T, Meinl E. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Curr Opin Neurol. 2022 Jun 1;35(3):427-435. doi: 10.1097/WCO.0000000000001052.