Brief 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.
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.
Brief Title
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Categories
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
Completion Date Type
Estimated
Conditions
ULCERATIVE COLITIS
Eligibility 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 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.
* 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.
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 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 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
16 Years
NCT Id
NCT07184996
Org Class
Industry
Org Full Name
Sanofi
Org Study Id
EFC18325
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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.
Primary Outcomes
Outcome Description
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.
Outcome Measure
Proportion of participants achieving clinical remission.
Outcome Time Frame
Week 12
Secondary Ids
Secondary Id
2025-521035-37
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants who achieve endoscopic improvement.
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. 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.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants achieving clinical response by modified Mayo Score (mMS).
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 12
Outcome Measure
Proportion of participants achieving histological endoscopic mucosal improvement.
Outcome Description
The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week.
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
Outcome Description
Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants with symptomatic (SFS and RBS) 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 12
Outcome Measure
Proportion of participants with no bowel urgency.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants reporting no nocturnal bowel movements.
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 4
Outcome Measure
Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Outcome Description
Endoscopic remission is defined as mMES of 0.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants who achieve endoscopic 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 12
Outcome Measure
Proportion of participants with no abdominal pain by Numeric 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
Baseline, Week 12
Outcome Measure
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
Outcome Time Frame
Baseline through Week 12
Outcome Measure
Proportion of participants with UC-related hospitalization.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants achieving clinical remission and no steroid use.
Outcome Time Frame
Baseline through 45 days after last dose
Outcome Measure
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.
Outcome Time Frame
Baseline through Week 12
Outcome Measure
Serum concentration of duvakitug measured over time.
Outcome Time Frame
Baseline through Week 12
Outcome Measure
Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ruby Greywoode
Investigator Email
rgreywoode@montefiore.org
Investigator Phone
347-671-8211
Investigator Department
Medicine
Investigator Division
Gastroenterology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Please Specify
Categories Mesh Debug
Digestive System --- COLITIS, ULCERATIVE
Digestive System --- COLITIS
Digestive System --- GASTROENTERITIS
Digestive System --- GASTROINTESTINAL DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- INFLAMMATORY BOWEL DISEASES
Digestive System --- COLONIC DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
COLITIS, ULCERATIVE
COLITIS
GASTROENTERITIS
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES
INFLAMMATORY BOWEL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES