Crohn's DiseasePhase 3STARSCAPE-2NCT07184944
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Duvakitug in people with Crohn's Disease, run by Sanofi at 109 sites in 27 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Duvakitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 751 participants
- Where
- 109 sitesin 27 countries
- Study dates
- 22 Jan 2026to 20 Mar 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 endoscopy at the end of STARSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Who cannot join
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
109 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
109 sites in 27 countries
United States34 sites, 34 recruiting
- Recruiting
GI Alliance - Baton Rouge-Site Number: 8400129
Baton Rouge, Louisiana, 70809
- Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
Chapel Hill, North Carolina, 27514
- Recruiting
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado, 80907
- Recruiting
Ohio Gastroenterology Group Inc.-Site Number: 8400006
Columbus, Ohio, 43202
- Recruiting
Medical Associates Research Group-Site Number: 8400063
Columbus, Ohio, 43210
- Recruiting
OSU Wexner Medical Center-Site Number: 8400077
Columbus, Ohio, 43210
- Recruiting
Cross Creek Medical Clinic-Site Number: 8400057
Fayetteville, North Carolina, 28304
- Recruiting
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
Gurnee, Illinois, 60031
- Recruiting
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida, 34741
- Recruiting
BVL Clinical Research-Site Number: 8400005
Liberty, Missouri, 64068
- Recruiting
GI Alliance - Lubbock-Site Number: 8400092
Lubbock, Texas, 79410
- Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
Mandeville, Louisiana, 70471
- Recruiting
MedTraits NY-Site Number: 8400045
Maspeth, New York, 11378
- Recruiting
SMS Clinical Research-Site Number: 8400035
Mesquite, Texas, 75149
- Recruiting
GI Alliance - Metairie-Site Number: 8400124
Metairie, Louisiana, 70006
- Recruiting
Columbus Clinical Services LLc-Site Number: 8400038
Miami, Florida, 33125
- Recruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida, 33175
- Recruiting
Delta Research Partners-Site Number: 8400087
Monroe, Louisiana, 71291
- Recruiting
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
New Albany, Indiana, 47150
- Recruiting
NYU Langone Health-Site Number: 8400091
New York, New York, 10016
- Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
New York, New York, 10065
- Recruiting
New York Gastroenterology Associates-Site Number: 8400009
New York, New York, 10075
- Recruiting
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
Orlando, Florida, 32806
- Recruiting
University of Pennsylvania School of Medicine-Site Number: 8400072
Philadelphia, Pennsylvania, 19104-6243
- Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
Pittsburgh, Pennsylvania, 15212
- Recruiting
University Gastroenterology - GI Alliance-Site Number: 8400103
Providence, Rhode Island, 02904
- Recruiting
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
San Antonio, Texas, 78229
- Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
Southlake, Texas, 76092
- Recruiting
Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri, 63141
- Recruiting
NMC Research LLC-Site Number: 8400033
Tampa, Florida, 33607
- Recruiting
Tyler Research Institute LLC-Site Number: 8400095
Tyler, Texas, 75701
- Recruiting
The Vancouver Clinic Inc. P.S.-Site Number: 8400090
Vancouver, Washington, 98664
- Recruiting
North Shore Gastroenterology Research-Site Number: 8400130
Westlake, Ohio, 44145
- Recruiting
Gastroenterology Associates of Western Michigan-Site Number: 8400060
Wyoming, Wyoming, 49519
Poland13 sites, 13 recruiting
- Recruiting
Investigational Site Number : 6160026
Bydgoszcz, 85-229
- Recruiting
Investigational Site Number : 6160013
Elblag, 82-300
- Recruiting
Investigational Site Number : 6160014
Katowice, 40-748
- Recruiting
Investigational Site Number : 6160030
Kłodzko, 57-300
- Recruiting
Investigational Site Number : 6160034
Lublin, 20-049
- Recruiting
Investigational Site Number : 6160025
Rzeszów, 35-326
- Recruiting
Investigational Site Number : 6160007
Staszów, 28-200
- Recruiting
Investigational Site Number : 6160020
Szczecin, 71-685
- Recruiting
Investigational Site Number : 6160023
Torun, 87-100
- Recruiting
Investigational Site Number : 6160012
Wadowice, 34-100
- Recruiting
Investigational Site Number : 6160008
Warsaw, 04-501
- Recruiting
Investigational Site Number : 6160006
Wroclaw, 52-416
- Recruiting
Investigational Site Number : 6160017
Wroclaw, 54-239
Ukraine7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 8040001
Kyiv, 2002
- Recruiting
Investigational Site Number : 8040013
Kyiv, 2091
- Recruiting
Investigational Site Number : 8040004
Lviv, 79000
- Recruiting
Investigational Site Number : 8040005
Lviv, 79019
- Recruiting
Investigational Site Number : 8040006
Uzhhorod, 88018
- Recruiting
Investigational Site Number : 8040010
Vinnytsia, 21013
- Recruiting
Investigational Site Number : 8040009
Vinnytsia, 21028
Georgia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2680006
Tbilisi, 102
- Recruiting
Investigational Site Number : 2680008
Tbilisi, 144
- Recruiting
Investigational Site Number : 2680003
Tbilisi, 159
- Recruiting
Investigational Site Number : 2680005
Tbilisi, 160
- Recruiting
Investigational Site Number : 2680002
Tbilisi, 180
- Recruiting
Investigational Site Number : 2680004
Tbilisi, 180
Canada5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 1240004
Edmonton, T6G 2X8
- Recruiting
Investigational Site Number : 1240009
Hamilton, L8N 1Y2
- Recruiting
Investigational Site Number : 1240013
London, N6K 1M6
- Recruiting
Investigational Site Number : 1240006
New Westminster, BC V3L 3W4
- Recruiting
Investigational Site Number : 1240003
Toronto, M6A 3B4
China4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 1560002
Guangzhou, 510655
- Recruiting
Investigational Site Number : 1560026
Huizhou, 516001
- Recruiting
Investigational Site Number : 1560020
Shanghai, 200123
- Recruiting
Investigational Site Number : 1560018
Wuxi, 214023
South Korea4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 4100008
Busan, 48108
- Recruiting
Investigational Site Number : 4100007
Gwangju, 61453
- Recruiting
Investigational Site Number : 4100006
Seoul, 6351
- Recruiting
Investigational Site Number : 4100002
Seoul, 6973
Australia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0400002
Salzburg, 5020
- Recruiting
Investigational Site Number : 0360001
South Brisbane, Queensland, 4101
- Recruiting
Investigational Site Number : 0400007
Vienna, 1190
Bulgaria3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1000003
Gorna Oryahovitsa, Oblast Veliko Tirnovo, 5100
- Recruiting
Investigational Site Number : 1000007
Rousse, 7000
- Recruiting
Investigational Site Number : 1000001
Sofia, 1618
Germany3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2760001
Kiel, Schleswig-Holstein, 24105
- Recruiting
Investigational Site Number : 2760015
Leipzig, Saxony, 4103
- Recruiting
Investigational Site Number : 2760005
Ulm, Baden-Wurttemberg, 89081
Japan3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3920030
Kamakura, 247-0056
- Recruiting
Investigational Site Number : 3920013
Nishinomiya, 663-8501
- Recruiting
Investigational Site Number : 3920009
Tsu, 514-8507
Moldova3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 4980002
Chisinau, MD-2025
- Recruiting
Investigational Site Number : 4980003
Chisinau, MD-2025
- Recruiting
Investigational Site Number : 4980004
Chisinau, MD-2068
South Africa3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7100002
Cape Town, 7405
- Recruiting
Investigational Site Number : 7100004
Durban, 3610
- Recruiting
Investigational Site Number : 7100001
Kempton Park, 1619
Czechia2 sites, 2 recruiting
- Recruiting
Investigational Site Number: 2030011
Hradec Králové, 500 12
- Recruiting
Investigational Site Number : 2030013
Prague, 150 00
Israel2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3760001
Jerusalem, 9103102
- Recruiting
Investigational Site Number : 3760002
Tel Aviv, 6423906
Italy2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3800003
Rozzano, 20089
- Recruiting
Investigational Site Number : 3800005
Turin, 10128
Switzerland2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7560002
Basel, CH-4058
- Recruiting
Investigational Site Number : 7560001
Bern, 3012
Austria1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0400001
Vienna, 1090
Belgium1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0560003
Yvoir, 5530
Brazil1 site, 1 recruiting
- Recruiting
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
São José do Rio Preto, 15090-000
Chile1 site, 1 recruiting
- Recruiting
Investigational Site Number : 1520001
Viña del Mar, 2540488
Lithuania1 site, 1 recruiting
- Recruiting
Investigational Site Number : 4400001
Kaunas, LT-50161
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280003
Tilburg, 5022 GC
New Zealand1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5540003
Lower Hutt, 5010
Serbia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 6880002
Belgrade, 11 080
Slovakia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7030001
Bratislava, 811 09
Taiwan1 site, 1 recruiting
- Recruiting
Investigational Site Number : 1580005
Changhua County, 500209
About this study
Official title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
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:
Read more
- 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
- Conditions
- Crohn's Disease
- Being tested
- Duvakitug, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvakitugDrug
Also called SAR447189
Pharmaceutical form:Injection solution-Route of administration:SC injection
PlaceboDrug
Pharmaceutical form:Injection solution-Route of administration:SC injection
| Study group | Role | What they receive |
|---|---|---|
| Duvakitug dose 1 | Experimental | Subcutaneous (SC) injection as per protocol Receives: Drug: Duvakitug |
| Du vakitug dose 2 | Experimental | SC injection as per protocol Receives: Drug: Duvakitug |
| Du vakitug dose 3 | Experimental | SC injection as per protocol Receives: Drug: Duvakitug |
| Placebo | Placebo comparator | SC injection as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 40
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40
Measured: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time
Measured: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent antidrug antibody (ADA) against duvakitug
Measured: 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
Measured: 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
Measured: Week 40 of pivotal maintenance through 45 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start22 Jan 2026
- Primary completion13 Aug 2029 (estimated)
- Study completion20 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 751 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184944
- Sponsor's protocol ID
- EFC18327
- Other IDs
- 2025-521037-86, U1111-1314-5471, 2025
- Acronym
- STARSCAPE-2
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT07184944
- Acronym / sponsor ID
- STARSCAPE-2 / EFC18327
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 751 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D LLC
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 13 Aug 2029 (estimated)
- Study completion
- 20 Mar 2034 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Duvakitug dose 1 | Experimental | Drug: DuvakitugSubcutaneous (SC) injection as per protocol |
| Du vakitug dose 2 | Experimental | Drug: DuvakitugSC injection as per protocol |
| Du vakitug dose 3 | Experimental | Drug: DuvakitugSC injection as per protocol |
| Placebo | Placebo comparator | Drug: PlaceboSC injection as per protocol |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 endoscopy at the end of STARSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Key exclusion criteria (3 listed)
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvakitugAlso: SAR447189Pharmaceutical form:Injection solution-Route of administration:SC injection | Drug | Du vakitug dose 2, Du vakitug dose 3, Duvakitug dose 1 |
| PlaceboPharmaceutical form:Injection solution-Route of administration:SC injection | Drug | Placebo |
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.
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.
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.
19 secondary outcomes
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
Time frame: Week 40
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
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
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
Time frame: Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
Time frame: Week 40
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
Time frame: Week 40
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Week 40
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
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
Time frame: Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent antidrug antibody (ADA) against duvakitug
Time frame: 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
Time frame: 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
Time frame: Week 40 of pivotal maintenance through 45 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- EFC18327 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
109 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duvakitug in people with Crohn's Disease, run by Sanofi at 109 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Poland, Ukraine, Georgia, Canada and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.