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

JRCT ID: jRCT2021210052

Registered date:24/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myelin oligodendrocyte glycoprotein (MOG)antibody-associated disease (MOG-AD)
• Date of first enrollment: 28/02/2022
• Target sample size: 11
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Italy,Japan,Mexico,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan,Ukraine,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Periods.
Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers.

Outcome(s)

Primary Outcome

Part A:
1. Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period
Part B:
2. Incidence of treatment-emergent adverse events (TEAEs) during Open-Label Extension (OLE)Treatment Period
3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period

Secondary Outcome

Part A:
1. Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the End of Double-Blind/Early Withdrawal (EDB/EWD) Visit
2. Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
3. Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period
4. Independently centrally adjudicated annualized relapse rate (ARR) during the DB Treatment Period
5. Change from Baseline in Low-Contrast Monocular Visual Acuity (Least Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit (with confirmation at 3 months)
6. Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period
Part A and B:
7. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 89age old
• Gender: Both

Include criteria

- 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

Exclude 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 or less

Related Information

• Primary Sponsor: MATSUO TETSUO
• Secondary ID(s): 2021-000352-19