Clinical trial • Phase II/III • Gastroenterology
OZANIMOD for Ulcerative colitis
Phase II/III trial of OZANIMOD for Ulcerative colitis. Randomised. 66 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 19-02-2024
- First CTIS Authorization Date
- 15-03-2024
Trial design
Randomised Phase II/III trial across 20 sites in Spain, France, Belgium and others.
- Randomised
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 66
- Trial Duration For Participant
- 364
Eligibility
Recruits 66 paediatric patients.
- Vulnerable Population
- Pediatric subjects are included (isVulnerablePopulationSelected = true). Assent and parental/guardian consent processes are provided: pediatric assent forms for age groups (e.g., Assent Age 12-15, Assent Age 16-17) and parent/guardian consent forms and information sheets are available. Multiple language versions of ICF/assent documents are present (examples: English, Spanish, French, German, Polish, Dutch).
Inclusion criteria
- {"criterion_text":"- Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit\n- Evidence of UC extending beyond the rectum, as determined by baseline endoscopy\n- Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy"}
Exclusion criteria
- {"criterion_text":"- Diagnosis of Crohn's disease or indeterminate colitis\n- Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool\n- Apheresis within 2 weeks of randomization\n- History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of subjects who achieve clinical remission, defined as all the following: • Mayo Endoscopy Subscore (MES) ≤ 1 • Rectal Bleeding Subscore (RBS) = 0 • Stool Frequency Subscore (SFS) ≤ 1, with a decrease of ≥ 1 point from Baseline SFS","definition_or_measurement_approach":"Clinical remission defined by composite 3-component Mayo score elements: MES ≤ 1; RBS = 0; SFS ≤ 1 with ≥1 point decrease from Baseline SFS (measured by endoscopy and symptom subscores)."}
- {"endpoint_text":"- Proportion of subjects who achieve histological remission, defined as the following: - Geboes index score < 2.0 - Robarts Histopathology Index (RHI) ≤ 3, with subscores of 0 for both lamina propria neutrophils and neutrophils in the epithelium","definition_or_measurement_approach":"Histological remission defined by Geboes index <2.0 and RHI ≤3 with subscores of 0 for lamina propria neutrophils and neutrophils in the epithelium (histopathology assessment)."}
- {"endpoint_text":"- Early Discontinuation: Starting at Week 5 or later if either one of the following criteria are met at 2 consecutive visits that are at least 2 weeks apart: - Partial Mayo score is ≥ 7 and is the same or worse than baseline, AND rectal bleeding and stool frequency are not improved from baseline - Partial Mayo score is 6 and worse than baseline, AND rectal bleeding and stool frequency are not improved from baseline","definition_or_measurement_approach":"Early discontinuation defined by partial Mayo score thresholds assessed at two consecutive visits ≥2 weeks apart (criteria as stated)."}
Secondary endpoints
- {"endpoint_text":"- Proportion of subjects who achieve clinical response defined as all the following: • Decrease from Baseline in the 3-component Mayo score of at least 2 points and at least 35% • Decrease in RBS of at least 1 point OR absolute RBS ≤ 1","definition_or_measurement_approach":"Clinical response defined by decrease from Baseline in 3-component Mayo score (≥2 points and ≥35%) and specified change in RBS (≥1 point decrease or absolute RBS ≤1)."}
- {"endpoint_text":"- Proportion of subjects who achieve clinical remission defined as all the following: • MES ≤ 1 • RBS = 0 • SFS ≤ 1, with a decrease of ≥1 point from Baseline SFS","definition_or_measurement_approach":"Same clinical remission definition as primary but listed as a secondary endpoint for different timepoints (MES, RBS, SFS criteria measured by endoscopy and symptom subscores)."}
- {"endpoint_text":"- Proportion of subjects who achieve symptomatic improvement of UC, defined as all the following: • RBS = 0 • SFS ≤ 1 • Decrease in SFS of ≥ 1 from Baseline","definition_or_measurement_approach":"Symptomatic improvement defined by RBS=0, SFS≤1 and ≥1 point decrease in SFS from Baseline (patient-reported symptoms)."}
- {"endpoint_text":"- Proportion of subjects who achieve endoscopic improvement, defined as MES ≤ 1","definition_or_measurement_approach":"Endoscopic improvement defined by Mayo Endoscopy Subscore (MES) ≤1 assessed by endoscopy."}
- {"endpoint_text":"- Proportion of subjects who achieve corticosteroid-free remission at Week 52, defined as all the following: • Did not receive steroids for ≥ 12 weeks prior to Week 52 • Achieved clinical remission defined by the 3-component Mayo score","definition_or_measurement_approach":"Corticosteroid-free remission defined by no steroid use for ≥12 weeks prior to Week 52 and achievement of clinical remission per 3-component Mayo score."}
- {"endpoint_text":"- Secondary – Safety and Tolerability Number and proportion of subjects experiencing AEs, SAEs, AEs leading to discontinuation from treatment, and AEs of interest (AEIs)","definition_or_measurement_approach":"Safety/tolerability measured by counts and proportions of adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and AEs of interest (AESIs)."}
- {"endpoint_text":"- Secondary - Pharmacokinetics Steady state systemic exposure of ozanimod and CC112273","definition_or_measurement_approach":"Pharmacokinetics measured as steady-state systemic exposure (e.g., PK parameters) of ozanimod and metabolite CC112273."}
- {"endpoint_text":"- Secondary – Pharmacodynamics Absolute and percent change from baseline in ALC","definition_or_measurement_approach":"Pharmacodynamic assessment via absolute and percent change from baseline in absolute lymphocyte count (ALC)."}
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 142
- Consent Approach
- Informed consent is managed with parent/guardian consent and pediatric assent. Age-specific assent documents are provided (examples: Assent Age 12-15, Assent Age 16-17) alongside parent/guardian information and consent forms. Multiple language versions of ICF and assent documents are available (documentation present in English, Spanish, French, German, Polish, Dutch and country-specific versions).
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 62
Spain
- Earliest CTIS Part Ii Submission Date
- 01-03-2024
- Latest Decision Or Authorization Date
- 25-03-2025
- Processing Time Days
- 389
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Servicio de Gastroenterologia
- Principal Investigator Name
- Javier Martin de Carpi
- Principal Investigator Email
- javier.martinc@sjd.es
- Contact Person Name
- Javier Martin de Carpi
- Contact Person Email
- javier.martinc@sjd.es
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Gastroenterology
- Principal Investigator Name
- Laura Palomino
- Principal Investigator Email
- laura_palomino_perez@hotmail.es
- Contact Person Name
- Laura Palomino
- Contact Person Email
- laura_palomino_perez@hotmail.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Unidad de Gastroenterologia
- Principal Investigator Name
- Montserrat Montraveta
- Principal Investigator Email
- mmontraveta.germanstrias@gencat.cat
- Contact Person Name
- Montserrat Montraveta
- Contact Person Email
- mmontraveta.germanstrias@gencat.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Pediatric Gastroenterology, Hepatology and Nutrition Unit
- Principal Investigator Name
- Cesar Sanchez
- Principal Investigator Email
- sangoros@hotmail.com
- Contact Person Name
- Cesar Sanchez
- Contact Person Email
- sangoros@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 01-03-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 644
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Pediatric Gastroenterology
- Principal Investigator Name
- Claire DUPONT-LUCAS
- Principal Investigator Email
- dupont-c@chu-caen.fr
- Contact Person Name
- Claire DUPONT-LUCAS
- Contact Person Email
- dupont-c@chu-caen.fr
- Site Name
- Hospital Femme Mere Enfant
- Department Name
- Hepato-Gastroenterology and Pediatric Nutrition
- Principal Investigator Name
- Rémi DUCLAUX-LORAS
- Principal Investigator Email
- remi.duclaux-loras@chu-lyon.fr
- Contact Person Name
- Rémi DUCLAUX-LORAS
- Contact Person Email
- remi.duclaux-loras@chu-lyon.fr
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Pediatric Gastroenterology and Nutrition
- Principal Investigator Name
- Franck RUEMMELE
- Principal Investigator Email
- frank.ruemmele@aphp.fr
- Contact Person Name
- Franck RUEMMELE
- Contact Person Email
- frank.ruemmele@aphp.fr
- Site Name
- Hopital Des Enfants
- Department Name
- Gastroenterology, Hepatology, Nutrition and Diseases Hereditary Metabolism
- Principal Investigator Name
- Emmanuel MAS
- Principal Investigator Email
- mas.e@chu-toulouse.fr
- Contact Person Name
- Emmanuel MAS
- Contact Person Email
- mas.e@chu-toulouse.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 01-03-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 643
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- Pediatric gastroenterology
- Principal Investigator Name
- Ilse Hoffman
- Principal Investigator Email
- ilse.hoffman@uzleuven.be
- Contact Person Name
- Ilse Hoffman
- Contact Person Email
- ilse.hoffman@uzleuven.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pediatric gastroenterology
- Principal Investigator Name
- Emeline Bequet
- Principal Investigator Email
- emeline.bequet@citadelle.be
- Contact Person Name
- Emeline Bequet
- Contact Person Email
- emeline.bequet@citadelle.be
- Site Name
- UZ Brussel
- Department Name
- Pediatric gastroenterology
- Principal Investigator Name
- Elisabeth De Greef
- Principal Investigator Email
- elisabeth.degreef@uzbrussel.be
- Contact Person Name
- Elisabeth De Greef
- Contact Person Email
- elisabeth.degreef@uzbrussel.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Dept of Paediatric Gastroenterology
- Principal Investigator Name
- Nicolette Moes
- Principal Investigator Email
- nicolette.moes@uza.be
- Contact Person Name
- Nicolette Moes
- Contact Person Email
- nicolette.moes@uza.be
Poland
- Earliest CTIS Part Ii Submission Date
- 01-03-2024
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 648
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii
- Principal Investigator Name
- Jarosław Kierkuś
- Principal Investigator Email
- j.kierkus@med-net.pl
- Contact Person Name
- Jarosław Kierkuś
- Contact Person Email
- j.kierkus@med-net.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Pediatrii, Gastroenterologii i Żywienia
- Principal Investigator Name
- Tomasz Pytrus
- Principal Investigator Email
- tomasz.pytrus@umw.edu.pl
- Contact Person Name
- Tomasz Pytrus
- Contact Person Email
- tomasz.pytrus@umw.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Uniw. Centrum Pediatrii Klinika Alergologii Gastroenterologii i Żywienia Dzieci ul. Pankiewicza 16
- Principal Investigator Name
- Ewa Toporowska-Kowalska
- Principal Investigator Email
- ewa.toporowska-kowalska@umed.lodz.pl
- Contact Person Name
- Ewa Toporowska-Kowalska
- Contact Person Email
- ewa.toporowska-kowalska@umed.lodz.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- gawdis@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- gawdis@twojaprzychodnia.com
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- WIP Warsaw IBD Point Profesor Kierkuś
- Principal Investigator Name
- Monika Meglicka
- Principal Investigator Email
- m.meglicka@wip.waw.pl
- Contact Person Name
- Monika Meglicka
- Contact Person Email
- m.meglicka@wip.waw.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 01-03-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 644
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Kinderklinik des Dr. v. Haunerschen Kinderspitals
- Principal Investigator Name
- Tobias Schwerd
- Principal Investigator Email
- tobias.schwerd@med.uni-muenchen.de
- Contact Person Name
- Tobias Schwerd
- Contact Person Email
- tobias.schwerd@med.uni-muenchen.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik fuer Kinder- und Jugendmedizin
- Principal Investigator Name
- Gunter Flemming
- Principal Investigator Email
- gunter.flemming@medizin.uni-leipzig.de
- Contact Person Name
- Gunter Flemming
- Contact Person Email
- gunter.flemming@medizin.uni-leipzig.de
- Site Name
- Technische Universitat Dresden
- Department Name
- CMCB, Center f. Regen. Therapies (AG Bonifacio)
- Principal Investigator Name
- Martin Laaß
- Principal Investigator Email
- martin.laass@uniklinikum-dresden.de
- Contact Person Name
- Martin Laaß
- Contact Person Email
- martin.laass@uniklinikum-dresden.de
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Iqvia Holdings Inc.
- Responsibilities
- Monitoring, Regulatory, Investigator recruitment, Data management, SUSAR reporting, Quality assurance auditing, Statistical analysis, Medical writing
- Name
- Icon Development Solutions LLC
- Responsibilities
- PK analysis
- Name
- Signant Health LLC
- Responsibilities
- eCOA, IVRS – treatment randomisation
- Name
- PPD Global Clinical Labs
- Responsibilities
- Sample management, kit building, storage and distribution of samples; biomarker analysis
- Name
- Biotel Research LLC
- Responsibilities
- ECG central reading, cardiac and imaging
Third parties
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"eCOA, IVRS – treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Global Clinical Labs","duties_or_roles":"Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis. Biomarker analysis will be also be performed","organisation_type":"Industry"}
- {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"biomarker analysis","organisation_type":"Health care"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Industry"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Monitoring Regulatory Investigator recruitment Data management SUSAR reporting Quality assurance auditing Statistical analysis Medical writing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"ECG Central reading, cardiac and imaging","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ozanimod
- Active Substance
- OZANIMOD
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised
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