A study to evaluate the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)

Phase 1

Conditions: Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)
MedDRA version: 20.0Level: HLTClassification code 10012302Term: Demyelinating disorders NECSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2021-000352-19-PT

Lead Sponsor: CB Biopharma SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

- Participants 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:
a) Optic neuritis (single, recurrent, or simultaneous bilateral)
b) Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM))
c) Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis
d) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

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 relevant active infection (eg, sepsis, pneumonia, or abscess), or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
- Participant has a current or medical history of primary immunodeficiency
- Participant has a current or medical history of IgA deficiency
- Participant tests positive for aquaporin-4 antibodies at screening
- Participant has a serum total IgG level =5.5g/L