Clinical trial • Phase III • Immunology
DUVAKITUG (Human IgG1 lambda monoclonal antibody against TL1A/TNFSF15) for Ulcerative colitis
Phase III trial of DUVAKITUG (Human IgG1 lambda monoclonal antibody against TL1A/TNFSF15) for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- 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); no dose/schedule for placebo specified in the provided data-controlled Phase III trial in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Comparator
- matched placebo for test product (matched placebo for Duvakitug); no dose/schedule for placebo specified in the provided data
- Target Sample Size
- 1134
Eligibility
Recruits 1134 paediatric patients.
- Vulnerable Population
- Vulnerable populations are included: paediatric/adolescent participants (16 to <18 years) may be enrolled where locally permitted if meeting Tanner Stage 5. The trial materials include age-specific informed consent and assent documents (e.g. L1_SIS and ICF_Main, Parent, Assent, Adolescent, Pediatric Assent) and parent/guardian consent templates, indicating that assent from minors and consent from parents/legal representatives are provided where applicable. Multiple language and country-specific ICF/assent documents are provided (e.g. BE-FR, BE-NL, EN, HU and other translations) and specific adolescent/parent forms are included.
Inclusion criteria
- {"criterion_text":"- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development"}
- {"criterion_text":"- Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline"}
- {"criterion_text":"- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies"}
Exclusion criteria
- {"criterion_text":"- Participants with Crohn’s Disease (CD), indeterminate colitis"}
- {"criterion_text":"- Current diagnosis of Ulcerative Proctitis"}
- {"criterion_text":"- Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections"}
- {"criterion_text":"- Prior or current high-grade gastrointestinal (GI) dysplasia"}
- {"criterion_text":"- Participants on treatment with but not on stable doses of conventional therapies prior to baseline"}
- {"criterion_text":"- Participants with prohibited medications or therapies prior to baseline"}
- {"criterion_text":"- Participants with previous exposure to anti-TL1A investigational therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving clinical remission.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants who achieve endoscopic improvement.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants achieving clinical response by modified Mayo Score (mMS).","definition_or_measurement_approach":"Clinical response measured by modified Mayo Score (mMS)."}
- {"endpoint_text":"- Proportion of participants achieving histological endoscopic mucosal improvement.","definition_or_measurement_approach":""}
- {"endpoint_text":"- 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 instrument)."}
- {"endpoint_text":"- Proportion of participants with symptomatic (SFS and RBS) remission","definition_or_measurement_approach":"Symptomatic remission defined using stool-frequency sub score (SFS) and rectal bleeding sub score (RBS)."}
- {"endpoint_text":"- Proportion of participants with no bowel urgency","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants reporting no nocturnal bowel movements","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.","definition_or_measurement_approach":"Symptomatic remission based on SFS and RBS subscores."}
- {"endpoint_text":"- Proportion of participants who achieve endoscopic remission.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).","definition_or_measurement_approach":"No abdominal pain measured by Numeric Rating Scale (NRS)."}
- {"endpoint_text":"- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.","definition_or_measurement_approach":"Change from baseline in total score of the Inflammatory Bowel Disease Questionnaire (IBDQ)."}
- {"endpoint_text":"- Proportion of participants with UC-related hospitalization","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants achieving clinical remission and no steroid use.","definition_or_measurement_approach":""}
- {"endpoint_text":"- 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 capturing incidence of TEAEs, TEAESIs, TESAEs and TEAEs leading to permanent discontinuation (treatment-emergent adverse events)."}
- {"endpoint_text":"- Serum concentration of duvakitug measured over time.","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of duvakitug over time."}
- {"endpoint_text":"- Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug","definition_or_measurement_approach":"Immunogenicity: incidence of treatment-emergent anti-drug antibodies (ADA) against duvakitug."}
Recruitment
- Registry Or Advocacy Recruitment
- True - Patient Advocacy Fact Sheet (advocacy material provided; no specific advocacy organisation named in the supplied metadata)
- Planned Sample Size
- 1134
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent and assent processes are age-specific. Adult participants provide informed consent (L1_SIS and ICF_Main). For minors/adolescents (16 to <18 where locally permitted) there are adolescent/pediatric assent forms and parent/legal representative consent forms (L1_SIS and ICF_Assent, L1_SIS and ICF_Parent, L1_SIS and ICF_Adolescent, L1_SIS and ICF_Pediatric Assent). Multiple language versions and country-specific redacted ICFs are provided (examples include English, BE-FR, BE-NL, HU and other translations listed in the documents).
Methods
- Physician referral: physician referral letters provided (K2_Recruitment materials_Physician Referral Letter) to refer potential participants to study sites.
- Patient-facing materials: patient leaflets and patient posters (K2_Recruitment Materials_Patient Leaflet / Patient Poster) to recruit participants at sites and public locations.
- Patient advocacy engagement: Patient Advocacy Fact Sheet provided to inform advocacy groups and patient organisations.
- Centre/site contact lists and site-specific recruitment arrangements (K1_Recruitment arrangements, L1_centre-specific contact list).
Geography
- Total Number Of Participants
- 1134
Austria
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 18
- Number Of Sites
- 8
- Number Of Participants
- 28
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 7
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 8
- Number Of Participants
- 25
France
- Earliest CTIS Part Ii Submission Date
- 28-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 12
- Number Of Sites
- 13
- Number Of Participants
- 27
Germany
- Earliest CTIS Part Ii Submission Date
- 04-02-2026
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 6
- Number Of Participants
- 82
Greece
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 183
- Number Of Sites
- 3
- Number Of Participants
- 8
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 10
Italy
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 91
- Number Of Participants
- 33
Lithuania
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 23
- Number Of Sites
- 2
- Number Of Participants
- 10
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 122
- Number Of Sites
- 2
- Number Of Participants
- 5
Norway
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 45
- Number Of Sites
- 1
- Number Of Participants
- 3
Poland
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 32
- Number Of Participants
- 168
Slovakia
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 116
- Number Of Sites
- 4
- Number Of Participants
- 30
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 77
- Number Of Participants
- 43
Spain
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 84
- Number Of Sites
- 5
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Psi Cro AG
- Responsibilities
- Central Laboratory; Monitoring, study startup, regulatory; Central Imaging reading; translation of clinical trial materials; various operational CRO tasks (as specified in sponsor third-party duties)
- Name
- Suvoda LLC
- Responsibilities
- Quality assurance / data management (contact qualityassurance@suvoda.com); data / quality related sponsor duties
- Name
- MARKEN Germany GmbH
- Responsibilities
- Logistics / supply chain responsibilities (sponsor duty code 14)
- Name
- Fisher Clinical Services UK Limited
- Responsibilities
- Logistics / site services (sponsor duty code 14)
Third parties
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Multiple entries: Central Laboratory; Monitoring, study startup, regulatory; Central Imaging reading; translation services; other operational roles (as listed in sponsor third-party duties)","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"Monitoring, study startup, regulatory","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Logistics / supply services (sponsor duty code present)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Quality assurance / data management responsibilities (sponsor duties codes present; contact qualityassurance@suvoda.com)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Logistics / other operational support (sponsor duty code 14)","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"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Other Psi Cro AG entries (various subsidiaries/addresses)","duties_or_roles":"Various operational roles (central lab, translation, monitoring, imaging reading, site services) as listed","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Logistics / site support (sponsor duties code 14)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Duvakitug
- Active Substance
- DUVAKITUG (Human IgG1 lambda monoclonal antibody against TL1A/TNFSF15)
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Investigational Product Name
- matched placebo for test product
- Modality
- Other
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