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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521037-86 | Registry Identifier | CTIS | |
| U1111-1314-5471 | Registry Identifier | ICTRP |
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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, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
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:
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvakitug dose 1 | Experimental | Subcutaneous (SC) injection as per protocol |
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| Du vakitug dose 2 | Experimental | SC injection as per protocol |
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| Du vakitug dose 3 | Experimental | SC injection as per protocol |
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| Placebo | Placebo Comparator | SC injection as per protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvakitug | Drug | Pharmaceutical form:Injection solution-Route of administration:SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40 | Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. | Week 40 |
| Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40 | The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading. | Week 40 |
| Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40 | Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. | Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40 | The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. Clinical Response by CDAI: decrease in CDAI score of 100 points or more from Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient'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 |
|---|---|---|---|---|---|---|
| Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 | Recruiting | Colorado Springs | Colorado | 80907 | United States |
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| Label | URL |
|---|---|
| EFC18327 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 SES-CD endoscopic remission at Week 40 | The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. | Week 40 |
| US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40 | The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Clinical Remission by CDAI: CDAI score <150. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. | Week 40 |
| EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40 | Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. | Week 40 |
| US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40 | Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. | Week 40 |
| EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40 | Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. | Week 40 |
| US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40 | Clinical Remission by CDAI: CDAI score <150 and without corticosteroid use for CD for at least 12 weeks prior to assessment. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. | Week 40 |
| EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40 | Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline and without corticosteroid use for CD for at least 12 weeks prior to assessment. | Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40 | Week 40 |
| US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI) | Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. | Week 40 |
| EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2) | Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. | Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40 | 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 T-scores indicate greater fatigue. | Baseline, Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40 | Inflammatory Bowel Disease Questionnaire (IBDQ) instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life. | Baseline, Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40 | Numeric Rating Scale (NRS) for bowel urgency measures 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: Incidence of CD related hospitalization by Week 40 | Week 0 through Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time | Week 0 through Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent antidrug antibody (ADA) against duvakitug | Week 0 through Week 40 |
| Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent adverse events (TEAEs), TEAE of special interest (TEAESIs), TE serious adverse events (TESAEs) and TEAEs leading to permanent study intervention discontinuation | Week 0 through 45 days after last dose |
| Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEsleading to permanent study intervention discontinuation | Week 40 of pivotal maintenance through 45 days after last dose |
| Clinical Research of Osceola-Site Number: 8400013 | Recruiting | Kissimmee | Florida | 34741 | United States |
| Bioresearch Partner-Kendale Lakes-Site Number: 8400053 | Recruiting | Miami | Florida | 33175 | 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 |
| Gateway Gastroenterology-Site Number: 8400097 | Recruiting | St Louis | Missouri | 63141 | United States |
| MedTraits NY-Site Number: 8400045 | Recruiting | Maspeth | New York | 11378 | United States |
| NYU Langone Health-Site Number: 8400091 | Recruiting | New York | New York | 10016 | United States |
| Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 | Recruiting | New York | New York | 10065 | United States |
| New York Gastroenterology Associates-Site Number: 8400009 | Recruiting | New York | New York | 10075 | United States |
| UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 | Recruiting | Chapel Hill | North Carolina | 27514 | 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 |
| University of Pennsylvania School of Medicine-Site Number: 8400072 | Recruiting | Philadelphia | Pennsylvania | 19104-6243 | 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 |
| Gastroenterology Associates of Western Michigan-Site Number: 8400060 | Recruiting | Wyoming | Wyoming | 49519 | United States |
| Investigational Site Number : 1240009 | Recruiting | Hamilton | L8N 1Y2 | Canada |
| Investigational Site Number : 1240003 | Recruiting | Toronto | M6A 3B4 | Canada |
| Investigational Site Number : 2680008 | Recruiting | Tbilisi | 144 | Georgia |
| Investigational Site Number : 2680003 | Recruiting | Tbilisi | 159 | Georgia |
| Investigational Site Number : 2680005 | Recruiting | Tbilisi | 160 | Georgia |
| Investigational Site Number : 2680002 | Recruiting | Tbilisi | 180 | Georgia |
| Investigational Site Number : 3920009 | Recruiting | Tsu | 514-8507 | Japan |
| Investigational Site Number : 4980003 | Recruiting | Chisinau | MD-2025 | Moldova |
| Investigational Site Number : 4980004 | Recruiting | Chisinau | MD-2068 | Moldova |
| Investigational Site Number : 7100001 | Recruiting | Kempton Park | 1619 | South Africa |
| Investigational Site Number : 8040005 | Recruiting | Lviv | 79019 | Ukraine |
| Investigational Site Number : 8040010 | Recruiting | Vinnytsia | 21013 | Ukraine |
| Investigational Site Number : 8040009 | Recruiting | Vinnytsia | 21028 | Ukraine |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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