> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-induction-study-to-investigate-the-efficacy-and-safety-of-185b067e-8e8d-405d-8405-e19901558fdf > Record changed: 2026-11-04 # An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis NCT07184996 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Participants 980 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Start date 2025-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) Number of sites 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Title and summary **Summary** This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: \* Screening period \* 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) \* 12-week Sub-Study 3 (Extended Induction for non-responders) \* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Acronym** SUNSCAPE-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Short title** An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Official title** A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Dates **Completion date** 2028-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **First posted** 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Registry last updated** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Primary completion date** 2028-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Start date** 2025-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Size and sites **Participants** 980 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Planned participants** 980 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Number of sites** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Identifiers **Registry ID** NCT07184996 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **ClinicalTrials.gov ID** NCT07184996 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Outcomes ### Primary outcomes 1. Proportion of participants achieving clinical remission. Timeframe: Week 12 Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. ### Secondary outcomes 1. Proportion of participants who achieve endoscopic improvement. Timeframe: Week 12 Endoscopic improvement is defined as MES of 0 or 1 (score of 1 excludes friability). Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). 2. Proportion of participants achieving clinical response by modified Mayo Score (mMS). Timeframe: Week 12 Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1\. mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. 3. Proportion of participants achieving histological endoscopic mucosal improvement. Timeframe: Week 12 Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1\. The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. 4. Change from baseline in PROMIS-Fatigue Short Form 7a T-score. Timeframe: Baseline, Week 12 The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week. 5. Proportion of participants with symptomatic (SFS and RBS) remission Timeframe: Week 12 Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0. 6. Proportion of participants with no bowel urgency. Timeframe: Week 12 The NRS for bowel urgency is a patient-reported tool designed to measure the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency". 7. Proportion of participants reporting no nocturnal bowel movements. Timeframe: Week 12 8. Proportion of participants with symptomatic (stool-frequency sub score \[SFS\] and = rectal bleeding sub score \[RBS\]) remission. Timeframe: Week 4 Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS. 9. Proportion of participants who achieve endoscopic remission. Timeframe: Week 12 Endoscopic remission is defined as mMES of 0. 10. Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS). Timeframe: Week 12 The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 ("no pain") to 10 ("worst possible pain"). 11. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score. Timeframe: Baseline, Week 12 IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life. 12. Proportion of participants with UC-related hospitalization. Timeframe: Baseline through Week 12 13. Proportion of participants achieving clinical remission and no steroid use. Timeframe: Week 12 14. 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. Timeframe: Baseline through 45 days after last dose 15. Serum concentration of duvakitug measured over time. Timeframe: Baseline through Week 12 16. Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug. Timeframe: Baseline through Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 16 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - 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 - Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline - Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies ### Exclusion criteria - Participants with Crohn's Disease (CD), indeterminate colitis - Current diagnosis of Ulcerative Proctitis - Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections - Prior or current high-grade gastrointestinal (GI) dysplasia - Participants on treatment with but not on stable doses of conventional therapies prior to baseline - Participants with prohibited medications or therapies prior to baseline - Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Sites - Onyx Clinical Research - Site Number: 8400021Peoria, United StatesRecruiting - One of a Kind Clinical Research Center LLC - Site Number: 8400061Scottsdale, United StatesRecruiting - Scottsdale Clinical Trials - Site Number: 8400145Scottsdale, United StatesRecruiting - Del Sol Research Management, LLC - Site Number: 8400012Tucson, United StatesRecruiting - Preferred Research Partners - Site Number: 8400018Little Rock, United StatesRecruiting - FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027Arcadia, United StatesRecruiting - Alliance Research Institute - Site Number: 8400008Canoga Park, United StatesRecruiting - Southern California GI & Liver Centers - Site Number: 8400062Coronado, United StatesRecruiting - GMC Clinical Research, LLC - Site Number: 8400113Folsom, United StatesRecruiting - Om Research, LLC - Lancaster - Site Number: 8400148Lancaster, United StatesRecruiting - TLC Clinical Research Inc. - Site Number: 8400030Los Angeles, United StatesRecruiting - United Medical Doctors CA - Site Number: 8400044Murrieta, United StatesRecruiting - Om Research, LLC - Oxnard - Site Number: 8400150Oxnard, United StatesRecruiting - UC Davis Health System - Site Number: 8400071Sacramento, United StatesRecruiting - Clinical Applications Laboratories Inc - Site Number: 8400056San Diego, United StatesRecruiting - Medical Associates Research Group - Site Number: 8400063San Diego, United StatesRecruiting - Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025Santa Maria, United StatesRecruiting - Valiance Clinical Research - Tarzana - Site Number: 8400023Tarzana, United StatesRecruiting - Clinical Trials Management Services - Site Number: 8400047Thousand Oaks, United StatesRecruiting - Amicis Research Center-Valencia -Site Number: 8400064Valencia, United StatesRecruiting - Om Research, LLC - Victorville - Site Number: 8400022Victorville, United StatesRecruiting - UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085Aurora, United StatesRecruiting - Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039Colorado Springs, United StatesRecruiting - Gastroenterology of the Rockies - Denver - Site Number: 8400122Denver, United StatesRecruiting - Yale University Digestive Disease - Site Number: 8400108New Haven, United StatesRecruiting And 215 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## References - Related resource (sanofi.trialsummaries.com) Source: [sanofi.trialsummaries.com](https://sanofi.trialsummaries.com/Study/StudyDetails?id=26860&tenant=MT%5FSNY%5F9011) - Related resource (euclinicaltrials.eu) Source: [euclinicaltrials.eu](https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-521035-37-00) ### Other registry identifiers (2) - 2025 - 2025-521035-37 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07184996) ## Related records ### Drugs (1) - [Duvakitug](https://trialight.com/data/asset/duvakitug-ac3c4efd-b6b2-4fdb-ac05-e2c892d58ae7.md) ### Collaborators (1) - [Teva Branded Pharmaceutical Products R&D, Inc.](https://trialight.com/data/company/teva-branded-pharmaceutical-products-r-d-inc-eb709623-d4a9-423d-9161-7b0540fb1b17.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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