Crohn's Disease
Phase 3 Maintenance Study of Duvakitug for Active Crohn's Disease
This Phase 3 maintenance study is investigating the efficacy and safety of injected duvakitug compared with placebo in people with moderately to severely active Crohn's disease who continue from specified earlier studies.
Registry title: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
22 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- Duvakitug or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Trial Transparency email recommended (Toll free for US & Canada)800-633-1610 ext. option 6Contact-US@sanofi.com
- Sponsor
- Sanofi
Research question
Among the specified participants with Crohn's disease, how do duvakitug and placebo compare for maintaining clinical and endoscopic outcomes, and what safety findings occur?
Participant snapshot
Who the study is looking for
- The study is looking for people with moderately to severely active Crohn's disease.
- Most participants must be 18 through 80 years old at baseline.
- Where locally permitted, participants aged 16 to under 18 may be considered if they meet the Tanner stage 5 development requirement.
- The pivotal maintenance sub-study is looking for participants who had a clinical response and completed the end-of-study endoscopy in STARSCAPE-1.
- The open-label extension is for participants completing the pivotal maintenance sub-study or participating in study TV48574-IMM-20038.
Participation overview
What participation may involve
Participants may receive subcutaneous duvakitug or placebo during the 40-week pivotal maintenance sub-study. Those entering the open-label extension may continue study treatment for another 240 weeks, followed by a 45-day follow-up. What participation may involve: - Receive study treatment by subcutaneous injection according to the protocol. - Complete assessments of Crohn's disease symptoms and signs, including stool frequency and abdominal pain reporting. - Undergo endoscopic assessment for measures of disease activity and ulcers. - Complete fatigue, quality-of-life, and bowel-urgency questionnaires or rating scales. - Provide blood samples for duvakitug concentration and anti-drug antibody assessments. Participation may last up to 286 weeks: 40 weeks in pivotal maintenance, 240 weeks in the open-label extension, and a 45-day follow-up. Without the extension, participation may last up to 46 weeks. The registry reports up to 43 on-site visits: 21 during pivotal maintenance and 22 during the open-label extension.
Study interventions
What participants may receive or do
- Duvakitug: Duvakitug, also called SAR447189, is given as a subcutaneous injection. The registry lists three experimental dose groups but does not state the doses.
- Placebo: The placebo is given as a subcutaneous injection in the placebo-comparator group.
Study design
How the comparison works
This is a Phase 3, parallel-group maintenance study with three duvakitug dose groups and one placebo group. It includes a 40-week pivotal maintenance sub-study and an optional 240-week open-label extension. Participants are assigned randomly to parallel study groups; the registry does not report the assignment ratio. The registry identifies the masking as quadruple: participants, care providers, investigators, and outcome assessors are masked. The control group receives a subcutaneous placebo injection, while three experimental groups receive different duvakitug doses. A placebo injection is used during the controlled study, but the registry does not state each participant's probability of receiving it.
Reported activities
Procedures and tests
- Subcutaneous injections of duvakitug or placebo are administered according to the study protocol.
- Endoscopy is used to assess Crohn's disease activity, endoscopic response or remission, and ulcer status.
- The Crohn's Disease Activity Index uses symptoms, clinical signs, and a laboratory test to assess disease activity.
- Participants report average daily stool frequency and abdominal pain for the two-item patient-reported outcome assessment.
- The seven-item PROMIS Fatigue Short Form assesses fatigue.
- The 32-item Inflammatory Bowel Disease Questionnaire assesses bowel and systemic symptoms, emotional function, and social function.
- An 11-point numeric rating scale records bowel urgency experienced during the previous 24 hours.
- Serum duvakitug concentrations and treatment-emergent anti-drug antibodies are measured over time.
- The study records adverse events, serious adverse events, events of special interest, and events leading to permanent discontinuation.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants generally must be 18 through 80 years old at baseline.
- Where local rules allow, people aged 16 to under 18 must meet the Tanner stage 5 development requirement.
- For the pivotal maintenance sub-study, participants must have achieved a clinical response and completed endoscopy at the end of STARSCAPE-1.
- For the open-label extension, participants must complete the pivotal maintenance sub-study or participate in study TV48574-IMM-20038.
Possible reasons someone may not be able to join
- The investigator may exclude someone because of a medical condition or a concern about following study requirements.
- A known hypersensitivity to duvakitug may exclude someone if the investigator considers them unsuitable for the study.
Important unknowns
What the record does not make clear
- The registry lists three duvakitug groups and one placebo group but does not provide the allocation ratio.
- The record does not explain which Crohn's disease treatments may be continued during the study.
- The record does not state whether any medicines must be stopped or how long before study treatment they must be stopped.
- The record does not describe what treatment is available if Crohn's disease worsens.
- Endoscopic outcomes are assessed at Week 40, but the complete endoscopy schedule and whether additional endoscopies occur in the extension are not reported.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, lodging, or other travel support is available.
- The registry reports on-site visits but does not state whether any visits or assessments may be completed remotely.
- The record does not describe access to duvakitug after study participation ends.
Before contacting the site
Questions for the study team
- Which study pathway and cohort would apply to me, and what prior-study requirements must be documented?
- What are the duvakitug doses, injection schedule, and locations where injections are given?
- What is the chance of receiving placebo, and when would I learn my assigned group?
- Which current Crohn's disease medicines may continue, and are any washout periods required?
- What happens if my Crohn's disease worsens, including what rescue treatments are permitted and when study treatment would stop?
- What is the full schedule for visits, injections, blood draws, questionnaires, and endoscopies?
- Is the open-label extension optional, what treatment is provided in it, and how is eligibility for it decided?
- Which costs are covered, and are compensation or travel assistance available?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease now, and what would worsening look like while considering this study?
- How could the study's medication-continuity or washout rules affect my current treatment plan?
- What approved treatment alternatives are reasonable for me if I do not enter this study or cannot remain in it?
- What risks or monitoring concerns should I discuss with the study team given my medical history and known treatments?
- How should my gastroenterology team and the research team coordinate routine care, endoscopies, laboratory monitoring, and treatment if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit 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: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study 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
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- EFC18327
- Lead sponsor
- Sanofi
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Duvakitug dose 1
Subcutaneous (SC) injection as per protocol
Interventions: Drug: Duvakitug
Experimental
Du vakitug dose 2
SC injection as per protocol
Interventions: Drug: Duvakitug
Experimental
Du vakitug dose 3
SC injection as per protocol
Interventions: Drug: Duvakitug
Placebo Comparator
Placebo
SC injection as per protocol
Interventions: Drug: Placebo
Interventions
Drug
Duvakitug
Pharmaceutical form:Injection solution-Route of administration:SC injection
Drug
Placebo
Pharmaceutical form:Injection solution-Route of administration:SC injection
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (3)
- 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)Registry-derived · unreviewed
- Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1Registry-derived · unreviewed
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 StudyRegistry-derived · unreviewed
Exclusion criteria (3)
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigatorRegistry-derived · unreviewed
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigatorRegistry-derived · unreviewed
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trialRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
Time frame: 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.
Primary outcome
Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Time frame: 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.
Primary outcome
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40
Time frame: 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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Time frame: 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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
Time frame: 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.
Secondary outcome
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
Time frame: 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.
Secondary outcome
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
Time frame: 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.
Secondary outcome
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
Time frame: 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.
Secondary outcome
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
Time frame: 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.
Secondary outcome
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
Time frame: 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.
Secondary outcome
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
Time frame: 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.
Secondary outcome
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
Time frame: Week 40
Secondary outcome
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)
Time frame: 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.
Secondary outcome
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)
Time frame: 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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
Time frame: Baseline, 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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
Time frame: Baseline, 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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
Time frame: 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".
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40
Time frame: Week 0 through Week 40
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time
Time frame: Week 0 through Week 40
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent antidrug antibody (ADA) against duvakitug
Time frame: Week 0 through Week 40
Secondary outcome
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
Time frame: Week 0 through 45 days after last dose
Secondary outcome
Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEsleading to permanent study intervention discontinuation
Time frame: Week 40 of pivotal maintenance through 45 days after last dose
Recruiting locations in the United States
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
RecruitingColorado Springs, Colorado, 80907, United States
Clinical Research of Osceola-Site Number: 8400013
RecruitingKissimmee, Florida, 34741, United States
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
RecruitingMiami, Florida, 33175, United States
NMC Research LLC-Site Number: 8400033
RecruitingTampa, Florida, 33607, United States
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
RecruitingNew Albany, Indiana, 47150, United States
GI Alliance - Baton Rouge-Site Number: 8400129
RecruitingBaton Rouge, Louisiana, 70809, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
RecruitingMandeville, Louisiana, 70471, United States
Gateway Gastroenterology-Site Number: 8400097
RecruitingSt Louis, Missouri, 63141, United States
MedTraits NY-Site Number: 8400045
RecruitingMaspeth, New York, 11378, United States
New York Gastroenterology Associates-Site Number: 8400009
RecruitingNew York, New York, 10075, United States
NYU Langone Health-Site Number: 8400091
RecruitingNew York, New York, 10016, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
RecruitingNew York, New York, 10065, United States
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
RecruitingChapel Hill, North Carolina, 27514, United States
Cross Creek Medical Clinic-Site Number: 8400057
RecruitingFayetteville, North Carolina, 28304, United States
Ohio Gastroenterology Group Inc.-Site Number: 8400006
RecruitingColumbus, Ohio, 43202, United States
OSU Wexner Medical Center-Site Number: 8400077
RecruitingColumbus, Ohio, 43210, United States
North Shore Gastroenterology Research-Site Number: 8400130
RecruitingWestlake, Ohio, 44145, United States
University of Pennsylvania School of Medicine-Site Number: 8400072
RecruitingPhiladelphia, Pennsylvania, 19104-6243, United States
GI Alliance - Lubbock-Site Number: 8400092
RecruitingLubbock, Texas, 79410, United States
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
RecruitingSan Antonio, Texas, 78229, United States
Tyler Research Institute LLC-Site Number: 8400095
RecruitingTyler, Texas, 75701, United States
Gastroenterology Associates of Western Michigan-Site Number: 8400060
RecruitingWyoming, Wyoming, 49519, United States
This study also lists 13 locations outside the United States. They are not shown here.
Central study contacts
Trial Transparency email recommended (Toll free for US & Canada)
Contact
Registry dates
- First posted
- Sep 22, 2025
- Primary completion
- Aug 13, 2029
- Overall completion
- Mar 20, 2034
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.