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

NCT05063162

Active Not RecruitingPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Interventions: Rozanolixizumab, Placebo

Countries: United States, Australia, Belgium, Brazil, Czechia, France, Germany, Greece

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 89 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
* Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
* Participant has history of relapsing MOGAD 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
Locations (55)
  • Scottsdale, Arizona, United States
  • Palo Alto, California, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Tampa, Florida, United States
  • Peoria, Illinois, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Melbourne, Australia
  • Ghent, Belgium
  • Porto Alegre, Brazil
  • Hradec Králové, Czechia
  • Teplice, Czechia
  • Strasbourg, France
  • Göttingen, Germany
  • Münster, Germany
  • Athens, Greece
  • Pavia, Italy
  • Roma, Italy
  • Verona, Italy
  • Chiba, Japan
  • Isehara, Japan
  • Kitakyushu, Japan
  • Kodaira, Japan
  • Kōriyama, Japan
  • Sendai, Japan
  • Sendai, Japan
  • + 25 more on CT.gov