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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521038-27 | Registry Identifier | CTIS |
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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D LLC | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvakitug - dose 1 | Experimental | Subcutaneous (SC) injection as per protocol |
|
| Duvakitug - dose 2 | Experimental | SC injection as per protocol |
|
| Duvakitug - dose 3 | Experimental | SC injection as per protocol |
|
| Placebo | Placebo Comparator | SC injection as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvakitug | Drug | Pharmaceutical form: Injection solution Route of administration: SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Sol Research Management, LLC - Site Number: 8400012 | Recruiting | Tucson | Arizona | 85715 | United States | |
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| Label | URL |
|---|---|
| EFC18359 Plain Language Results Summary | View source |
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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
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| Placebo | Drug | Pharmaceutical form:Injection solution-Route of administration:SC injection |
|
| 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 â€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. | Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission. | 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". | 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. | Baseline, Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission. | Endoscopic remission is defined as mMES of 0. | 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 â„2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of â„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. | 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"). | 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. | Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations. | 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 â„30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS. | 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. | 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. | Week 0 through 45 days after last dose |
| Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time. | Week 0 through Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug. | 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. | Week 40 of pivotal maintenance through 45 days after last dose |
| Southern California GI & Liver Centers - Site Number: 8400062 |
| Recruiting |
| Coronado |
| California |
| 92118 |
| United States |
| United Medical Doctors CA - Site Number: 8400044 | Recruiting | Murrieta | California | 92563 | United States |
| Om Research, LLC - Victorville - Site Number: 8400022 | Recruiting | Victorville | California | 92395 | United States |
| Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 | Recruiting | Colorado Springs | Colorado | 80907 | United States |
| Royal Palm Clinical Research - Site Number: 8400065 | Recruiting | Fort Myers | Florida | 33901 | United States |
| Clinical Research of Osceola - Site Number: 8400013 | Recruiting | Kissimmee | Florida | 34741 | United States |
| Bioresearch Partner-Kendale Lakes - Site Number: 8400053 | Recruiting | Miami | Florida | 33155 | United States |
| NMC Research LLC - Site Number: 8400033 | Recruiting | Tampa | Florida | 33607 | United States |
| Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100 | Recruiting | New Albany | Indiana | 47150 | United States |
| GI Alliance - Baton Rouge - Site Number: 8400129 | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128 | Recruiting | Mandeville | Louisiana | 70471 | United States |
| Delta Research Partners - Site Number: 8400087 | Recruiting | Monroe | Louisiana | 71291 | United States |
| Gastroenterology Associates of Western Michigan - Site Number: 8400060 | Recruiting | Wyoming | Michigan | 49519 | United States |
| Gateway Gastroenterology - Site Number: 8400097 | Recruiting | Chesterfield | Missouri | 63017 | United States |
| BVL Clinical Research - Site Number: 8400005 | Recruiting | Liberty | Missouri | 64068 | United States |
| MedTraits NY - Site Number: 8400045 | Recruiting | Maspeth | New York | 11378 | United States |
| New York Gastroenterology Associates - Site Number: 8400009 | Recruiting | New York | New York | 10075 | United States |
| Cross Creek Medical Clinic - Site Number: 8400057 | Recruiting | Fayetteville | North Carolina | 28304 | United States |
| Ohio Gastroenterology Group Inc. - Site Number: 8400006 | Recruiting | Columbus | Ohio | 43202 | United States |
| OSU Wexner Medical Center - Site Number: 8400077 | Recruiting | Columbus | Ohio | 43210 | United States |
| North Shore Gastroenterology Research - Site Number: 8400130 | Recruiting | Westlake | Ohio | 44145 | United States |
| GI Alliance - Lubbock - Site Number: 8400092 | Recruiting | Lubbock | Texas | 79410 | United States |
| Gastroenterology Research of San Antonio LLC - Site Number: 8400054 | Recruiting | San Antonio | Texas | 78229 | United States |
| Tyler Research Institute, LLC - Site Number: 8400095 | Recruiting | Tyler | Texas | 75701 | United States |
| The Vancouver Clinic Inc. P.S. - Site Number: 8400090 | Recruiting | Vancouver | Washington | 98664 | United States |
| Investigational Site Number : 1240003 | Recruiting | Toronto | Ontario | M6A 3B4 | Canada |
| Tokai University Hachioji Hospital - Site Number : 3920031 | Recruiting | HachiĆji | 192-0032 | Japan |
| Investigational Site Number : 3920049 | Recruiting | Kagoshima | 892-0843 | Japan |
| Investigational Site Number : 3920030 | Recruiting | Kamakura | 247-0056 | Japan |
| Investigational Site Number : 3920019 | Recruiting | Kobe | 650-0015 | Japan |
| Investigational Site Number : 3920029 | Recruiting | Sapporo | 004-0041 | Japan |
| Investigational Site Number : 3920009 | Recruiting | Tsu | 514-8507 | Japan |
| Investigational Site Number : 6880001 | Recruiting | Belgrade | 11,000 | Serbia |
| Investigational Site Number : 6880002 | Recruiting | Belgrade | 11000 | Serbia |
| Investigational Site Number : 8040001 | Recruiting | Kyiv | 2002 | Ukraine |
| Investigational Site Number : 8040002 | Recruiting | Kyiv | 3037 | Ukraine |
| Investigational Site Number : 8040005 | Recruiting | Lviv | 79019 | Ukraine |
| Investigational Site Number : 8040006 | Recruiting | Uzhhorod | 88018 | Ukraine |
| Investigational Site Number : 8040008 | Recruiting | Vinnytsia | 21029 | Ukraine |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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