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

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including:

* 40-week Pivotal Maintenance Sub-Study
* 240-week Open-Label Extension (OLE) Sub-Study
* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

* 40 weeks in Pivotal Maintenance Sub-Study
* 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

* 21 visits in the Pivotal Maintenance Sub-Study.
* 11 visits in the OLE Sub-Study.

Brief Title

Categories

Digestive System

Liver

Pediatrics / Children's Health

Central Contacts

Central Contact Role

Contact

Central Contact Phone

800-633-1610

Central Contact Phone Ext

option 6

Central Contact Email

contact-us@sanofi.com

Completion Date

2033-04-28

Completion Date Type

Estimated

Conditions

ULCERATIVE COLITIS

Eligibility Criteria

Inclusion Criteria:

* 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)
* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria:

* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Inclusion Criteria

Inclusion Criteria:

* 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)
* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Gender

All

Gender Based

false

Healthy Volunteers

No

Last Update Post Date

Fri, 06/12/2026 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Thu, 06/11/2026 - 12:00

Maximum Age

80 Years

Minimum Age

16 Years

NCT Id

NCT07185009

Org Class

Industry

Org Full Name

Sanofi

Org Study Id

EFC18359

Overall Status

Recruiting

Phases

Phase 3

Primary Completion Date

Thu, 09/21/2028 - 12:00

Primary Completion Date Type

Estimated

Official Title

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Primary Outcomes

Outcome Description

Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).

Outcome Time Frame

Week 40

Secondary Ids

Secondary Id

2025-521038-27

Secondary Outcomes

Outcome Description

Endoscopic improvement is defined as mMES 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).

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.

Outcome Description

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.

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.

Outcome Description

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".

Outcome Time Frame

Week 40

Outcome Measure

Proportion of participants with no bowel urgency.

Outcome Description

The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher Tscores indicate greater fatigue.

Outcome Time Frame

Baseline, Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.

Outcome Description

Endoscopic remission is defined as mMES of 0.

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.

Outcome Description

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.

Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.

Outcome Time Frame

Week 40

Outcome Measure

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).

Outcome Description

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").

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).

Outcome Description

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.

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score

Outcome Time Frame

Week 0 through Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.

Outcome Description

Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.

Outcome Time Frame

Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.

Outcome Time Frame

Week 40

Outcome Measure

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.

Outcome Time Frame

Week 0 through 45 days after last dose

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.

Outcome Time Frame

Week 0 through Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.

Outcome Time Frame

Week 0 through Week 40

Outcome Measure

Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.

Outcome Time Frame

Week 40 of pivotal maintenance through 45 days after last dose

Outcome Measure

Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.