Clinical trial • Phase III • Immunology|Gastroenterology

DUVAKITUG for Crohn's disease

Phase III trial of DUVAKITUG for Crohn's disease.

Overview

Trial Therapeutic Area: Immunology|Gastroenterology
Trial Disease: Crohn's disease
Trial Stage: Phase III
Drug Modality: Monoclonal antibody
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 20-10-2025
First CTIS Authorization Date: 24-02-2026

Trial design

Randomised, matched placebo for test product (placebo comparator) versus duvakitug (investigational product). dose and dosing schedule not specified in the provided metadata.-controlled Phase III trial in Austria, Belgium, Bulgaria and others.

Randomised: Yes
Comparator: Matched placebo for test product (placebo comparator) versus Duvakitug (investigational product). Dose and dosing schedule not specified in the provided metadata.
Target Sample Size: 465
Trial Duration For Participant: 280

Eligibility

Recruits 465 paediatric patients.

Vulnerable Population: The protocol selects vulnerable populations (isVulnerablePopulationSelected: true). Adolescents are addressed: participants 16 to <18 years may be eligible where locally permissible if they meet Tanner stage 5. The application includes age-specific subject information and consent/assent documents (e.g. L1_SIS and ICF_Adolescent_Redacted, L1_SIS and ICF_Parent_Redacted, pediatric assent and LAR documents), indicating use of adolescent assent and parental/legal representative consent procedures as per local regulation.

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 STARSCAPE-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":"- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission (CDAI) at Week 40","definition_or_measurement_approach":"Clinical remission assessed by CDAI at Week 40 (CDAI score as specified in protocol)"}
{"endpoint_text":"- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40","definition_or_measurement_approach":"Endoscopic response assessed by SES-CD at Week 40"}
{"endpoint_text":"- Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission per PRO-2 at Week 40","definition_or_measurement_approach":"Patient-reported clinical remission evaluated by PRO-2 at Week 40"}
{"endpoint_text":"- Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40","definition_or_measurement_approach":"Endoscopic response assessed by SES-CD at Week 40"}

Secondary endpoints

{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40","definition_or_measurement_approach":"CDAI clinical response assessed at Week 40"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40","definition_or_measurement_approach":"SES-CD endoscopic remission at Week 40"}
{"endpoint_text":"- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40","definition_or_measurement_approach":"Concurrent CDAI clinical remission and endoscopic remission at Week 40"}
{"endpoint_text":"- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40","definition_or_measurement_approach":"Concurrent PRO-2 clinical remission and endoscopic remission at Week 40"}
{"endpoint_text":"- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40","definition_or_measurement_approach":"PRO-2 clinical remission at Week 40"}
{"endpoint_text":"- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40","definition_or_measurement_approach":"CDAI clinical remission at Week 40"}
{"endpoint_text":"- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40","definition_or_measurement_approach":"CDAI clinical remission at Week 40 without corticosteroid use"}
{"endpoint_text":"- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40","definition_or_measurement_approach":"PRO-2 clinical remission at Week 40 without corticosteroid use"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40","definition_or_measurement_approach":"Endoscopic absence of ulcers at Week 40 in baseline ulcer subset"}
{"endpoint_text":"- US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)","definition_or_measurement_approach":"Maintenance of CDAI clinical remission at Week 40 among those in CDAI remission at Week 0"}
{"endpoint_text":"- EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)","definition_or_measurement_approach":"Maintenance of PRO-2 clinical remission at Week 40 among those in PRO-2 remission at Week 0"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40","definition_or_measurement_approach":"Change in PROMIS-Fatigue Short Form 7a T-score from baseline to Week 40"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40","definition_or_measurement_approach":"Change in IBDQ total score from baseline to Week 40"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40","definition_or_measurement_approach":"Proportion with NRS = no bowel urgency at Week 40"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40","definition_or_measurement_approach":"Incidence of Crohn's disease-related hospitalizations through Week 40"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time","definition_or_measurement_approach":"Serial measurement of serum duvakitug concentrations (PK profile)"}
{"endpoint_text":"- Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent antidrug antibody (ADA) against duvakitug","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies (immunogenicity)"}
{"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 TEAEs leading to permanent study intervention discontinuation","definition_or_measurement_approach":"Safety endpoints: incidence of TEAEs, TEAESIs, TESAEs and TEAEs leading to permanent discontinuation"}
{"endpoint_text":"- Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent study intervention discontinuation","definition_or_measurement_approach":"Safety endpoints in OLE: incidence of TEAEs, TEAESIs, TESAEs and TEAEs leading to permanent discontinuation"}

Recruitment

Registry Or Advocacy Recruitment: True: Patient Advocacy Fact Sheet is included among recruitment materials (no specific advocacy organisation named in the public metadata)
Planned Sample Size: 465
Recruitment Window Months: 98
Consent Approach: Adults (≥18 years) provide informed consent using the Main SIS and ICF. For adolescents (16 to <18 years where locally permissible and meeting Tanner stage 5) adolescent-specific information and assent forms are provided (L1_SIS and ICF_Adolescent_Redacted, L1_SIS and ICF_Pediatric Assent documents) and parental/legal representative consent materials are available (L1_SIS and ICF_Parent_Redacted, L1_SIS and ICF_LAR documents). Multiple language versions and country-specific ICFs are included in the submission (e.g. English, French, Dutch, German, Hungarian and other country-specific translations as per document listings).

Methods

Physician referral (documents: Physician Referral Letter listed in recruitment materials)
Patient-facing printed materials and posters (Patient Poster, Patient Leaflet) for site/community recruitment
Patient advocacy outreach (Patient Advocacy Fact Sheet provided as recruitment material)
Site-based recruitment through participating hospitals and clinics (multicentre sites listed by country)

Geography

Total Number Of Participants: 465

Austria

Earliest CTIS Part Ii Submission Date: 16-02-2026
Latest Decision Or Authorization Date: 01-03-2026
Processing Time Days: 13
Number Of Participants: 9

Belgium

Earliest CTIS Part Ii Submission Date: 18-02-2026
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 6
Number Of Participants: 4

Bulgaria

Earliest CTIS Part Ii Submission Date: 13-02-2026
Latest Decision Or Authorization Date: 02-03-2026
Processing Time Days: 17
Number Of Participants: 11

France

Earliest CTIS Part Ii Submission Date: 17-02-2026
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 7
Number Of Participants: 13

Germany

Earliest CTIS Part Ii Submission Date: 06-02-2026
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 19
Number Of Participants: 34

Greece

Earliest CTIS Part Ii Submission Date: 07-11-2025
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 110
Number Of Participants: 3

Hungary

Earliest CTIS Part Ii Submission Date: 10-02-2026
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 15
Number Of Participants: 8

Lithuania

Earliest CTIS Part Ii Submission Date: 13-02-2026
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 11
Number Of Participants: 2

Spain

Earliest CTIS Part Ii Submission Date: 02-02-2026
Latest Decision Or Authorization Date: 27-02-2026
Processing Time Days: 25
Number Of Participants: 8

Norway

Earliest CTIS Part Ii Submission Date: 18-02-2026
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 7
Number Of Participants: 2

Poland

Earliest CTIS Part Ii Submission Date: 10-02-2026
Latest Decision Or Authorization Date: 26-02-2026
Processing Time Days: 16
Number Of Participants: 60

Slovakia

Earliest CTIS Part Ii Submission Date: 16-02-2026
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 8
Number Of Participants: 10

Czechia

Earliest CTIS Part Ii Submission Date: 16-02-2026
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 8
Number Of Participants: 24

Italy

Earliest CTIS Part Ii Submission Date: 09-02-2026
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 16
Number Of Participants: 14

Netherlands

Earliest CTIS Part Ii Submission Date: 16-02-2026
Latest Decision Or Authorization Date: 26-02-2026
Processing Time Days: 10
Number Of Participants: 2

Sponsor

Primary sponsor

Full Name: Sanofi-Aventis Recherche & Developpement
Organisation Type: Pharmaceutical company
Country Of Registered Address: France

Contract research organisations

Name: ESMS Global Limited
Responsibilities: Centralized 24-Hour Emergency System: eSMS

Name: Psi CRO Greece
Responsibilities: Monitoring, Regulatory and Study Start-up

Name: Teckro Limited
Responsibilities: Application for sites to get access to study documents/Q&A - protocol application

Name: Psi Cro AG
Responsibilities: eCOA, central reading, central laboratory, translation of trial materials and related services

Name: Fisher Clinical Services UK Limited
Responsibilities: sponsor duties coded as 14 in metadata (role not expanded in public metadata)

Name: MARKEN Germany GmbH
Responsibilities: sponsor duties coded as 14 in metadata (role not expanded in public metadata)

Name: Suvoda LLC
Responsibilities: sponsor duties coded as 14 and 3 in metadata (roles not expanded in public metadata)

Third parties

{"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","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":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"Monitoring, Regulatory and Study Start-up","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":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Multiple responsibilities including Clinical Outcomes Assessment Instrument (eCOA), Central Medical Reading or Imaging Reading, Central laboratory, Translation of Clinical Trial Materials (No sponsor QC); sponsorDuties codes: 1,12,15,2,5,6","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 14,3 (values not expanded in metadata)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name: Duvakitug
Active Substance: DUVAKITUG
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: prodAuthStatus 1

Investigational Product Name: Matched placebo for test product
Modality: Other

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