This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:
The study duration may be up to 35 weeks with:
* Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
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 Crohn's Disease (CD) for at least 3 months prior to baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Participants with Ulcerative Colitis (UC) or indeterminate colitis
Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapy prior to baseline
Parallel
Duvakitug
DrugPharmaceutical form:Injection solution Route of administration:SC injection
Placebo
DrugPharmaceutical form:Injection solution Route of administration:SC injection
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
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.
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
Endoscopic Response is defined as 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. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
Clinical Remission per 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.
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
Endoscopic Response is defined as 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. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline.
Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline. Endoscopic Response by SES-CD was defined as 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.
Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12
Endoscopic Remission by SES-CD is defined as SES-DC ≤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
Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12
Clinical Remission per PRO-2: average daily SF ≤3 and not worse than the Baseline, and average daily AP ≤1 and not worse than the Baseline.
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Sanofi
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Collaborator
