An induction study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease

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 Crohn's Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250559

Enrollment

980

Registered

2025-12-08

Start date

2025-12-16

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Drug: Duvakitug (SAR447189) Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection Drug: Placebo Pharmaceutical form: Injection solution Route of administrati

Eligibility

Sex/Gender

All

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 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).

Exclusion criteria

Exclusion criteria: - 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. - Participants receiving prohibited medications or therapies. - Participants with previous exposure to anti-tumor necrosis factor-like cytokine 1A (TL1A) investigational therapy.

Design outcomes

Primary

Measure	Time frame
1. Sub-Study 2: Co-primary endpoints United States (US) / Food and Drug Administration (FDA): Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [Time Frame: Week 12] Clinical Remission by CDAI: CDAI score =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. 3. Sub-Study 2: Co-primary endpoints European Union (EU) / European Medicines Agency (EMA): Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12 [Time Frame: 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. 4. Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12 [Time Frame: Week 12] Refer to the primary outcome-2 for "Endoscopic Response (SES-CD)".	—

Measure

Time frame

1. Sub-Study 2: Co-primary endpoints United States (US) / Food and Drug Administration (FDA): Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [Time Frame: Week 12] Clinical Remission by CDAI: CDAI score =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. 3. Sub-Study 2: Co-primary endpoints European Union (EU) / European Medicines Agency (EMA): Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12 [Time Frame: 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. 4. Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12 [Time Frame: Week 12] Refer to the primary outcome-2 for "Endoscopic Response (SES-CD)".

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Secondary

Measure	Time frame
1. Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12 [Time Frame: Week 12] CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline. 2. Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12 [Time Frame: Week 12] Refer to the secondary outcome-1 for "CDAI clinical response" and to the primary outcome-2 for "Endoscopic Response (SES-CD)". 3. Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12 [Time Frame: Week 12] Endoscopic Remission by SES-CD is defined as SES-DC =2 points with no SES-CD sub score >1 point from baseline. 4. Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12 [Time Frame: Week 12] Refer to the primary outcome-3 for "Clinical Remission per PRO-2". 5. Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12 [Time Frame: Week 12] Refer to the primary outcome-1 for "clinical remission per CDAI". 6. Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12 [Time Frame: Week 12] Ulcer-free endoscopy: SES-CD ulcerated surface sub-score of 0 in participants with SES-CD ulcerated surface sub-score >=1 at Baseline, as scored by a central reader. 7. Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12 [Time Frame: Baseline, Week 12] 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. 8. Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4 [Time Frame: Week 4] Refer to	—

Measure

Time frame

1. Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12 [Time Frame: Week 12] CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline. 2. Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12 [Time Frame: Week 12] Refer to the secondary outcome-1 for "CDAI clinical response" and to the primary outcome-2 for "Endoscopic Response (SES-CD)". 3. Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12 [Time Frame: Week 12] Endoscopic Remission by SES-CD is defined as SES-DC =2 points with no SES-CD sub score >1 point from baseline. 4. Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12 [Time Frame: Week 12] Refer to the primary outcome-3 for "Clinical Remission per PRO-2". 5. Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12 [Time Frame: Week 12] Refer to the primary outcome-1 for "clinical remission per CDAI". 6. Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12 [Time Frame: Week 12] Ulcer-free endoscopy: SES-CD ulcerated surface sub-score of 0 in participants with SES-CD ulcerated surface sub-score >=1 at Baseline, as scored by a central reader. 7. Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12 [Time Frame: Baseline, Week 12] 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. 8. Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4 [Time Frame: Week 4] Refer to

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Countries

Japan, United States

Contacts

Public ContactUnit Clinical

Sanofi K.K.

clinical-trials-jp@sanofi.com+81-3-6301-3670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026