Clinical trial • Phase III • Neurology|Rare Disease

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

Phase III trial of ROZANOLIXIZUMAB for Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD).

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
22-08-2024

Trial design

Randomised, open-label, rozanolixizumab (rystiggo 140 mg/ml solution for injection) versus placebo (rozanolixizumab, also known as ucb7665 used as placebo); dose and schedule not specified in the provided ctis data.-controlled Phase III trial in Belgium, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Rozanolixizumab (Rystiggo 140 mg/ml solution for injection) versus Placebo (Rozanolixizumab, also known as UCB7665 used as placebo); dose and schedule not specified in the provided CTIS data.
Target Sample Size
65

Eligibility

Recruits 65 No vulnerable population selected (isVulnerablePopulationSelected=false). Participants must be ≥18 years and provide informed consent; no assent process for minors is described because minors are excluded..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Participants must be ≥18 years and provide informed consent; no assent process for minors is described because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Participants must be ≥18 to ≤89 years of age, at the time of signing the informed consent\n- Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD\n- Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cellbased assay (CBA) within 6 months prior to randomization\n- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period"}

Exclusion criteria

  • {"criterion_text":"- 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\n- 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)\n- Participant has a current or medical history of primary immunodeficiency\n- Participant tests positive for aquaporin-4 antibodies at screening\n- Participant has a serum total IgG level ≤5.5g/L"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- For Part A: 1.Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period","definition_or_measurement_approach":"Time from randomization to the first relapse that is independently and centrally adjudicated during the Double-Blind treatment period (TTFR)."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Incidence (counts and percentages) of treatment-emergent adverse events during the Open-Label Extension period; and incidence of TEAEs that lead to permanent withdrawal of the IMP during the OLE period."}

Secondary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Change from baseline in low-contrast monocular visual acuity (worst affected eye) measured using low-contrast Landolt C Broken Rings Chart at the EDB/EWD visit."}
  • {"endpoint_text":"- Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months)","definition_or_measurement_approach":"EDSS score at end of EDB/EWD visit with confirmation of disability change at 3 months."}
  • {"endpoint_text":"- Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period","definition_or_measurement_approach":"Count of inpatient hospitalizations judged related to MOG-AD occurring during the Double-Blind treatment period."}
  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period","definition_or_measurement_approach":"Incidence (counts and percentages) of TEAEs occurring during the Double-Blind treatment period."}
  • {"endpoint_text":"- For Part B 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period","definition_or_measurement_approach":"Annualized relapse rate adjudicated independently and centrally during both Double-Blind and Open-Label Extension treatment periods."}

Recruitment

Registry Or Advocacy Recruitment
True, Center For Information And Study On Clinical Research Participation Inc. (patient organisation/association) is listed among third parties
Digital Remote Recruitment
True, web-based recruitment materials are present (K2_*recr-web* files) across multiple countries; third parties listed include Clinical Ink Inc. and Perceptive Eclinical Limited which indicate use of digital/electronic platforms
Planned Sample Size
65
Recruitment Window Months
65
Consent Approach
Informed consent is obtained from each participant (participants must be ≥18 years). Multiple country-specific informed consent forms and information sheets are available (documents L1_*icf* and L1_*cons-nav* in multiple languages). ICFs are provided in multiple country/language versions (examples in the document list include German, French, English, Dutch, Portuguese, Polish, Czech, Swedish, Italian, Spanish, Greek, Korean, Turkish, Ukrainian, Japanese). No assent process for minors is described because minors are excluded.

Methods

  • Web-based recruitment materials (files named K2_*recr-web* present for multiple countries: BE, CZ, FR, DE, SE, PT, PL, ES, IT, GR, etc.)
  • Patient information brochure (PIB) materials (files named K2_*recr-pib* present for multiple countries: BE, CZ, FR, DE, SE, PT, PL, ES, IT, GR, etc.)
  • Site advertisement / site materials (files named K2_*recr-sam* / K2_*recr-sma* present for multiple countries)
  • Posters and printed recruitment materials (e.g., K2_*recr-poster* present for France)
  • Country-specific recruitment process documents (K1_*icf-recr-proc* files present for BE, CZ, DE, SE, PT, PL, IT, etc.)

Geography

Total Number Of Sites
34
Total Number Of Participants
45

Belgium

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
516
Number Of Sites
4
Number Of Participants
2

Sites

Site Name
Antwerp University Hospital
Department Name
40122: Neurology
Contact Person Name
Barbara Willekens
Contact Person Email
barbara.willekens@uza.be
Site Name
Hopital Erasme
Department Name
40123: Neurologie
Contact Person Name
Sophie Elands
Contact Person Email
sophie.elands@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
40756: Neurologie pédiatrique
Contact Person Name
Vincent Van Pesch
Contact Person Email
vincent.vanpesch@uclouvain.be
Site Name
Universitair Ziekenhuis Gent
Department Name
40185: Neuromuscular Reference Centre (NMRC)
Contact Person Name
Guy Laureys
Contact Person Email
guy.laureys@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
482
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
40124: Neurologicka klinika
Contact Person Name
Petra Nytrova
Contact Person Email
petra.nytrova@vfn.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
40195: Neurologicka klinika
Contact Person Name
Zbysek Pavelek
Contact Person Email
zbysekpavelek@email.cz
Site Name
Krajska zdravotni a.s.
Department Name
40721: Neurologicke oddeleni
Contact Person Name
Marta Vachova
Contact Person Email
marta.vachova@kzcr.eu

France

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
523
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
40755: Service de Neurologie
Contact Person Name
Pierre Labauge
Contact Person Email
labauge@yahoo.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
40170: Service de Neurologie
Contact Person Name
Jerome De Seze
Site Name
Hospices Civils De Lyon
Department Name
40657: Service de Neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation
Contact Person Name
Romain Marignier
Contact Person Email
romain.marignier@chu-lyon.fr

Germany

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
481
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
German Rheumatism Research Centre
Department Name
40659
Contact Person Name
Friedemann Paul
Contact Person Email
friedemann.paul@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
40577: Klinik und Poliklinik für Neurologie
Contact Person Name
Makbule Senel
Contact Person Email
makbule.senel@uni-ulm.de
Site Name
University Hospital Cologne AöR
Department Name
#40386: Neurology
Contact Person Name
Michael Schroeter
Contact Person Email
michael.schroeter@uk-koeln.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
40177: Klinik für Neurologie
Contact Person Name
Luisa Klotz
Contact Person Email
luisa.klotz@ukmuenster.de
Site Name
Universitaetsmedizin Goettingen
Department Name
40140:Klinik für Neurologie
Contact Person Name
Martin Weber

Sweden

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
475
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Karolinska University Hospital
Department Name
40663: Neurologiska kliniken
Contact Person Name
Katharina Fink

Portugal

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
513
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
40485: Neurologia
Contact Person Name
Carla Nunes
Contact Person Email
carlacecilianunes@gmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
40669: Neurologia
Contact Person Name
Ernestina Santos
Contact Person Email
ernestina.santos@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
196
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
40634: Zespół Poradni Specjalistycznych – Botaniczna 3 Poradnia Neurologiczna
Contact Person Name
Agnieszka Slowik
Contact Person Email
slowik@cm-uj.krakow.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
40856: Klinika Neurologii
Contact Person Name
Beata Zakrzewska - Pniewska
Contact Person Email
beata.zakrzewska@wum.edu.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Department Name
40840: Neurocentrum
Contact Person Name
Robert Bonek
Contact Person Email
bonek.robert@gmail.com
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
40089: Oddzial Neurologiczny
Contact Person Name
Monika Adamczyk - Sowa
Contact Person Email
m.adamczyk.sowa@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
263
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
40851: B' Department of Neurology
Contact Person Name
Nikolaos Grigoriadis
Contact Person Email
grigoria@med.auth.gr
Site Name
Eginitio Hospital
Department Name
40850: A' Department of Neurology
Contact Person Name
Maria-Eleftheria Evangelopoulos
Contact Person Email
evangelopoulos@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
512
Number Of Sites
6
Number Of Participants
5

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
40100: Neurologia
Contact Person Name
Lucienne Costa-Frossard França
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
40049: Neurología
Contact Person Name
Sara Eichau Madueño
Contact Person Email
saraeichau@hotmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
40267: Neurología
Contact Person Name
Yolanda Blanco Morgado
Contact Person Email
yblanco@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
40161: Neurologia
Contact Person Name
Ricardo Ginestal Lopez
Contact Person Email
rcginestal@yahoo.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
40341: Neurología
Contact Person Name
Ana Alonso-Torres
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
40350: Unidad Esclerosis Multiple
Contact Person Name
José Meca Lallana
Contact Person Email
pmecal@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
468
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Fondazione Istituto G. Giglio Di Cafalu
Department Name
40448: Neurologia
Contact Person Name
Luigi Maria Grimaldi
Contact Person Email
luigi.grimaldi@hsrgiglio.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
40646: Neurologia B
Contact Person Name
Sara Mariotto
Contact Person Email
sara.mariotto@gmail.com
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
40146: NEUROLOGIA GENERALE
Contact Person Name
Matteo Gastaldi
Contact Person Email
matteo.gastaldi@mondino.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
40629: Neurologia
Contact Person Name
Raffaele Iorio

Sponsor

Primary sponsor

Full Name
UCB Biopharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
PPD Development L.P.
Responsibilities
PK
Name
Parexel International (IRL) Limited
Responsibilities
Project managment, Regulatory, Investigator recruitment, DM, SUSAR reporting, QA auditing, Other duties
Name
Icon Clinical Research Limited
Responsibilities
"Routine clinical pathology testing Clinical chemistry Clinical haematology Serology/ endocrinology"
Name
Merit CRO Inc.
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc.
Name
Accellacare Limited
Responsibilities
Home nursing

Third parties

  • {"country":"United States","full_name":"Quest Diagnostics Inc.","duties_or_roles":"\"Vaccination-specific antibody titers for tetanus, PPV23 and Men (A,C,W135,Y)\"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"PK","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"\"COVID-19 biomarkers sampling; Anti-SARSCoV- 2 S (Spike) protein assay\"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Neutralizing ADA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"code 11","organisation_type":"Patient organisation/association"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mayo Clinic Hospital Rochester","duties_or_roles":"MOG antibody quantification","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Trilogy Writing & Consulting GmbH","duties_or_roles":"code 11","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Ixico Technologies Limited","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"\"Future biomarker analysis, optional samples for RNA/DANN\"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"NFL (Serum), GFAP (Serum), blinded ADA","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Project managment, Regulatory, Investigator recruitment, DM, SUSAR reporting, QA auditing, Other duties","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"\"Routine clinical pathology testing Clinical chemistry Clinical haematology Serology/ endocrinology\"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Athena Diagnostics Inc.","duties_or_roles":"MOG autoantibody and Aquaporin-4 antibody detection","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Cardiabase","duties_or_roles":"ECG analysis/ review","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Rystiggo 140 mg/ml solution for injection
Active Substance
ROZANOLIXIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketing authorisation EU/1/23/1780/001)
Investigational Product Name
Rozanolixizumab, also known as UCB7665 (Placebo role listed)
Modality
Other
Authorisation Status
Not specified / placebo

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