A Phase 3 interventional study of Duvakitug and Placebo in Ulcerative Colitis, sponsored by Sanofi. Recruiting at 171 sites in 31 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, China, Czechia, Greece, Israel, Italy, Moldova, Netherlands, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom
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:
The treatment duration may be up to 280 weeks including:
The total number of on-site visit will be up to 32:
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 751 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous (SC) injection as per protocol
Drug: Duvakitug
SC injection as per protocol
Drug: Duvakitug
SC injection as per protocol
Drug: Duvakitug
SC injection as per protocol
Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Pharmaceutical form:Injection solution-Route of administration:SC injection
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
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)
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.
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).
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.
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.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.
Time frame: Week 40
Proportion of participants with no bowel urgency.
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".
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.
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.
Time frame: Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.
Endoscopic remission is defined as mMES of 0.
Time frame: Week 40
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).
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.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).
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").
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
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.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
Time frame: Week 40
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.
Time frame: Week 40
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.
Time frame: Week 0 through 45 days after last dose
Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Time frame: Week 0 through Week 40
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.
Time frame: Week 40 of pivotal maintenance through 45 days after last dose
Showing the first 100 of 171 sites across 31 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Started Jan 2026 (actual). Primary completion is estimated for Sep 2028, 32 months after the start.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's planned 32 months is below that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, China, Czechia, Greece, Israel, Italy, Moldova, Netherlands, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, China, Czechia, Greece, Israel, Italy, Moldova, Netherlands, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Duvakitug