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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509237-39-00
Acronym
MOG001
Enrollment
45
Registered
2024-08-22
Start date
2022-08-02
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)

Brief summary

For Part A: 1.Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period, For 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

Detailed description

For 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, Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months), Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period, Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period, For Part B 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period

Interventions

DRUGRozanolixizumab
DRUGalso known as UCB7665
DRUG-

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For Part A: 1.Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period, For 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

MeasureTime frame
For 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, Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months), Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period, Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period, For Part B 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period

Countries

Belgium, Czechia, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026