An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07184996
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
980
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Lead sponsor
Sanofi
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Start date
2025-10-08
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Number of sites
240
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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.
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Acronym
SUNSCAPE-1
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Short title
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
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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.
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-05-09
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First posted
2025-09-22
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Registry last updated
2026-10-23
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Primary completion date
2028-05-09
clinicaltrials.gov
Start date
2025-10-08
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Participants
980
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Participant count basis
Estimated
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Planned participants
980
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Protocol amendments
1
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Number of sites
240
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07184996
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ClinicalTrials.gov ID
NCT07184996
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
16 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • 2025-521035-37
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)