An induction study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250558

Enrollment

980

Registered

2025-12-08

Start date

2025-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

Drug: Duvakitug (SAR447189) Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous (SC) injection Drug: Placebo Pharmaceutical form: Solution for injection Route of admi

Eligibility

Sex/Gender

All

Inclusion criteria

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 Ulcerative Colitis (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

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-tumor necrosis factor-like cytokine 1A (TL1A) investigational therapy. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
1. Proportion of participants achieving clinical remission [Time Frame: Week 12] Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including stool-frequency sub score (SFS) of 0 or 1, rectal bleeding sub score (RBS) of 0, and Mayo Endoscopic Subscore (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.	—

Measure

Time frame

1. Proportion of participants achieving clinical remission [Time Frame: Week 12] Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including stool-frequency sub score (SFS) of 0 or 1, rectal bleeding sub score (RBS) of 0, and Mayo Endoscopic Subscore (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.

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Secondary

Measure	Time frame
1. Proportion of participants who achieve endoscopic improvement [Time Frame: 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 mMS [Time Frame: 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 RBS of >=1 or an absolute RBS 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 [Time Frame: Week 12] Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score =30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS. 9. Proportion of participants who achieve endoscopic remission [Time Frame: Week 12] Endoscopic remission is defined as MES of 0. 10. Proportion of participants with no abdominal pain by NRS [Time Frame: 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 [Time Frame: Baseline, Week 12] IBDQ is a tool to the quality of life of individuals suffering from inflammatory bowel disease (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 hospitaliza	—

Measure

Time frame

1. Proportion of participants who achieve endoscopic improvement [Time Frame: 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 mMS [Time Frame: 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 RBS of >=1 or an absolute RBS 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 [Time Frame: Week 12] Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score =30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS. 9. Proportion of participants who achieve endoscopic remission [Time Frame: Week 12] Endoscopic remission is defined as MES of 0. 10. Proportion of participants with no abdominal pain by NRS [Time Frame: 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 [Time Frame: Baseline, Week 12] IBDQ is a tool to the quality of life of individuals suffering from inflammatory bowel disease (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 hospitaliza

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Countries

Japan, United States

Contacts

Public ContactUnit Clinical

Sanofi K.K.

clinical-trials-jp@sanofi.com+81-3-6301-3670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026