Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT05063162
Active, not recruiting Phase 3

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

NCT05063162 · tracked via the Priya Life Science Italy tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2022-02-02
Last updated
2026-09-25

Condition(s) studied

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Investigational drug(s) / intervention(s)

Rozanolixizumab →Placebo

Rozanolixizumab: * Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.

Placebo: * Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive placebo.

Study 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 (MOGAD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period — Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
    The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit
  • For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period — OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit.
  • For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period — OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.

Trial sites (55)

FacilityCityRegionStatus
Mog001 50297 Scottsdale Arizona
Mog001 50450 Palo Alto California
Mog001 50101 Aurora Colorado
Mog001 50553 Washington D.C. District of Columbia
Mog001 50308 Tampa Florida
Mog001 50472 Peoria Illinois
Mog001 50552 Baltimore Maryland
Mog001 50243 Boston Massachusetts
Mog001 50104 Rochester Minnesota
Mog001 50568 San Antonio Texas
Mog001 50473 Salt Lake City Utah
Mog001 30022 Melbourne Australia
Mog001 40185 Ghent Belgium
Mog001 60033 Porto Alegre Brazil
Mog001 40195 Hradec Králové Czechia
Mog001 40721 Teplice Czechia
Mog001 40170 Strasbourg France
Mog001 40140 Göttingen Germany
Mog001 40177 Münster Germany
Mog001 40850 Athens Greece
Mog001 40146 Pavia Italy
Mog001 40629 Roma Italy
Mog001 40646 Verona Italy
Mog001 20068 Chiba Japan
Mog001 20307 Isehara Japan
Mog001 20049 Kitakyushu Japan
Mog001 20143 Kodaira Japan
Mog001 20223 Koriyama-shi Japan
Mog001 20224 Sendai Japan
Mog001 20227 Sendai Japan
Mog001 20070 Shinjuku-ku Japan
Mog001 20032 Suita Japan
Mog001 50486 Culiacán Mexico
Mog001 50485 Mexico City Mexico
Mog001 40840 Bydgoszcz Poland
Mog001 40485 Coimbra Portugal
Mog001 40669 Porto Portugal
Mog001 20226 Goyang-si South Korea
Mog001 40267 Barcelona Spain
Mog001 40161 Madrid Spain

+ 15 more sites — see the full list on the official registry below.

More UCB Biopharma SRL trials in Italy

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Recruiting
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures Enrolling by invitation
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis Active, not recruiting
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus Enrolling by invitation
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05063162 on ClinicalTrials.gov ↗ ← All trials in Italy