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Duvakitug

Phase 3

Crohn's Disease | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jul 15, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,731
FDA Designations
No designations recorded
Clinical trial landscape

Duvakitug · 4 trials · 2 indications

Phase 3 4
NCT07184944A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's Disease
RECRUITING751 Analytics
NCT07185009A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
RECRUITING671 Analytics
NCT07184996An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
RECRUITING980 Analytics
NCT07184931An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's Disease
RECRUITING980 Analytics
PHASE3RECRUITING
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics
PHASE3RECRUITING
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE3RECRUITING
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE3RECRUITING
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics
Study Endpoints
Primary Endpoints
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
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.

Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
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.

Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40
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.

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
Week 40

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)

Proportion of participants achieving clinical remission.
Week 12

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.

Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
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&#x0027;s Disease [SES-CD]) at Week 12
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
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
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.

Secondary Endpoints
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
Week 40
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Duvakitug dose 1EXPERIMENTALSubcutaneous (SC) injection as per protocol
Du vakitug dose 2EXPERIMENTALSC injection as per protocol
Du vakitug dose 3EXPERIMENTALSC injection as per protocol
PlaceboPLACEBO_COMPARATORSC injection as per protocol
Duvakitug - dose 1EXPERIMENTALSubcutaneous (SC) injection as per protocol
Duvakitug - dose 2EXPERIMENTALSC injection as per protocol
Duvakitug - dose 3EXPERIMENTALSC injection as per protocol
Duvakitug Dose 2EXPERIMENTALSC injection as per protocol
Interventions
NameTypeDescription
DuvakitugDRUGPharmaceutical form:Injection solution-Route of administration:SC injection
PlaceboDRUGPharmaceutical form:Injection solution-Route of administration:SC injection
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Eligibility Criteria
Age Range16 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development) * Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endosc...

Countries:United StatesCanadaGeorgiaJapanMoldovaSouth AfricaUkraineLithuaniaPolandSerbiaBulgariaChinaCzechiaFranceGermanyHungaryPuerto RicoSlovakiaSwitzerlandTaiwanArgentinaAustraliaAustriaBelgiumBrazilChileGreeceIsraelItalyNew ZealandSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJul 15, 2026NCT07185009lastUpdatePostDate: changed
LOWJul 15, 2026NCT07185009lastUpdatePostDate: changed
LOWJul 2, 2026NCT07184931lastUpdatePostDate: changed
LOWJul 2, 2026NCT07184931lastUpdatePostDate: changed
LOWJul 2, 2026NCT07184931lastUpdatePostDate: changed
LOWJul 2, 2026NCT07184931lastUpdatePostDate: changed
LOWJun 22, 2026NCT07184944lastUpdatePostDate: changed
LOWJun 22, 2026NCT07184944lastUpdatePostDate: changed
LOWJun 12, 2026NCT07185009lastUpdatePostDate: changed
LOWJun 12, 2026NCT07185009lastUpdatePostDate: changed
LOWMay 29, 2026NCT07184931lastUpdatePostDate: changed
LOWMay 29, 2026NCT07184931lastUpdatePostDate: changed
LOWMay 26, 2026NCT07184944Enrollment: 671 → 751
LOWMay 26, 2026NCT07185009primaryCompletionDate: changed
LOWMay 26, 2026NCT07184996primaryCompletionDate: changed
LOWMay 26, 2026NCT07184931primaryCompletionDate: changed
LOWMay 24, 2026NCT07184944studyFirstPostDate: changed
LOWMay 24, 2026NCT07185009studyFirstPostDate: changed
LOWMay 24, 2026NCT07184996studyFirstPostDate: changed
LOWMay 24, 2026NCT07184931studyFirstPostDate: changed