Clinical trial • Phase III • Immunology|Gastroenterology
DUVAKITUG for Ulcerative colitis|Moderately to severely active ulcerative colitis
Phase III trial of DUVAKITUG for Ulcerative colitis|Moderately to severely active ulcerative colitis.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology
- Trial Disease
- Ulcerative colitis|Moderately to severely active ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 06-10-2025
- First CTIS Authorization Date
- 09-02-2026
Trial design
Randomised, matched placebo for test product (matched placebo for duvakitug). dose and schedule not specified in the ctis record.-controlled Phase III trial in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Comparator
- matched placebo for test product (matched placebo for Duvakitug). Dose and schedule not specified in the CTIS record.
- Target Sample Size
- 467
- Trial Duration For Participant
- 280
Eligibility
Recruits 467 paediatric patients.
- Vulnerable Population
- Vulnerable populations are selected. The protocol allows inclusion of 16 to <18 year olds where locally permissible (participants meeting Tanner stage 5). Age-specific consent materials are provided (participant ICF, parent/legally acceptable representative ICF, pediatric/adolescent assent forms and parent forms). Separate pregnancy follow-up / partner pregnancy information documents and optional pediatric/assent documents are included in the application materials.
Inclusion criteria
- {"criterion_text":"- Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)"}
- {"criterion_text":"- Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1"}
- {"criterion_text":"- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study"}
Exclusion criteria
- {"criterion_text":"- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator"}
- {"criterion_text":"- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).","definition_or_measurement_approach":"Clinical remission assessed by modified Mayo Score (mMS); endpoint is the proportion of participants achieving clinical remission per mMS."}
Secondary endpoints
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.","definition_or_measurement_approach":"Endoscopic improvement as assessed by endoscopy (endoscopic score improvement)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.","definition_or_measurement_approach":"Histologic and endoscopic assessment of mucosal improvement (histologic endoscopic mucosal improvement)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.","definition_or_measurement_approach":"Proportion achieving clinical remission without corticosteroid use."}
- {"endpoint_text":"- Proportion of participants with no bowel urgency.","definition_or_measurement_approach":"Proportion of participants reporting absence of bowel urgency (patient-reported symptom measure)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS- Fatigue Short Form 7a T-score.","definition_or_measurement_approach":"Change from baseline in PROMIS-Fatigue Short Form 7a T-score (patient-reported outcome)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.","definition_or_measurement_approach":"Endoscopic remission as determined by endoscopic assessment."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission).","definition_or_measurement_approach":"Subset analysis of maintenance of clinical remission by mMS among those in remission at end of induction."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).","definition_or_measurement_approach":"Proportion with NRS score indicating no abdominal pain (patient-reported numerical rating scale)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.","definition_or_measurement_approach":"Change from baseline in IBDQ total score (health-related quality of life measure)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.","definition_or_measurement_approach":"Incidence (count) of hospitalizations related to ulcerative colitis during study period."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.","definition_or_measurement_approach":"Proportion meeting symptomatic remission defined by stool-frequency subscore (SFS) and rectal bleeding subscore (RBS)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis.","definition_or_measurement_approach":"Proportion achieving clinical remission without steroid use from baseline to analysis timepoint."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation.","definition_or_measurement_approach":"Safety endpoints: incidence counts of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent discontinuation (standard safety monitoring and reporting)."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.","definition_or_measurement_approach":"Pharmacokinetic endpoint: serum concentration-time profile of duvakitug."}
- {"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.","definition_or_measurement_approach":"Immunogenicity: incidence of treatment-emergent anti-drug antibodies detected during treatment."}
- {"endpoint_text":"- Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation.","definition_or_measurement_approach":"Safety endpoints in OLE: incidence counts of TEAEs, TEAESIs, TESAEs and events leading to permanent discontinuation during open-label extension."}
Recruitment
- Registry Or Advocacy Recruitment
- True (Patient Advocacy Fact Sheet materials included; specific advocacy organisation names are not listed in the CTIS metadata)
- Planned Sample Size
- 467
- Recruitment Window Months
- 86
- Consent Approach
- Informed consent obtained using participant ICF; for minors (where permitted, 16 to <18) site-specific adolescent/pediatric assent and parent/legally acceptable representative consent forms are provided. Additional consent-related documents include partner/pregnancy follow-up information and optional procedures consent. Consent and assent documents are provided in multiple languages (English and country-specific translations such as French, Dutch, Hungarian, Polish, German, Spanish, Greek, Bulgarian, Slovak etc as evidenced by multiple language-specific ICF and synopsis documents in the submission).
Methods
- Site-based recruitment via participating hospitals and gastroenterology clinics (site contact lists and centre-specific materials provided).
- Physician referral (physician referral letters provided as recruitment material).
- Patient-facing materials: patient leaflets and posters distributed at sites.
- Patient advocacy engagement: patient advocacy fact sheet provided (materials intended to inform advocacy groups / patients).
- Country-specific recruitment materials and translations (documents prepared per country/language as submitted).
Geography
- Total Number Of Participants
- 209
Austria
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 18
- Number Of Participants
- 12
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 27
- Number Of Participants
- 4
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 29-01-2026
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 15
- Number Of Participants
- 10
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 21
- Number Of Participants
- 18
France
- Earliest CTIS Part Ii Submission Date
- 29-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 11
- Number Of Participants
- 13
Germany
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 20
- Number Of Participants
- 34
Greece
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 113
- Number Of Participants
- 3
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 27
- Number Of Participants
- 5
Italy
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 22
- Number Of Participants
- 14
Lithuania
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 23
- Number Of Participants
- 4
Spain
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 28
- Number Of Participants
- 8
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 122
- Number Of Participants
- 2
Norway
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 46
- Number Of Participants
- 2
Poland
- Earliest CTIS Part Ii Submission Date
- 18-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 29
- Number Of Participants
- 68
Slovakia
- Earliest CTIS Part Ii Submission Date
- 18-01-2026
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 23
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Psi CRO Greece
- Responsibilities
- Monitoring , study startup, regulatory
- Name
- Psi Cro AG
- Responsibilities
- Multiple responsibilities across monitoring, central laboratory, central imaging reading, translations and other operational functions (various duty codes listed)
- Name
- ESMS Global Limited
- Responsibilities
- Centralized 24-Hour Emergency System: eSMS
- Name
- Suvoda LLC
- Responsibilities
- Data management / clinical trial systems
- Name
- Fisher Clinical Services UK Limited
- Responsibilities
- Central Laboratory
- Name
- MARKEN Germany GmbH
- Responsibilities
- Logistics / supply chain
- Name
- Teckro Limited
- Responsibilities
- Study document access application support
Third parties
- {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"Monitoring , study startup, regulatory","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Other , Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"multiple roles (codes provided: central laboratory, translation, monitoring etc) as listed in sponsor third-party duties","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Central laboratory (duty code 14 listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Data management / clinical trial systems (duty codes 3 and 14 listed)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Logistics / supply chain (duty code 14 listed)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Application for sites to get access to study documents/Q&A - protocol application","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Duvakitug
- Active Substance
- DUVAKITUG
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Investigational Product Name
- matched placebo for test product
- Modality
- Other
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