Ulcerative ColitisPhase 3SUNSCAPE-2NCT07185009
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Duvakitug in people with Ulcerative Colitis, run by Sanofi at 171 sites in 31 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- 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
- 171 sitesin 31 countries
- Study dates
- 16 Jan 2026to 28 Apr 2033
- 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 SUNSCAPE-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 participant's potential participation in a clinical trial.
Trial locations and contacts
171 sites in 31 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
171 sites in 31 countries
United States37 sites, 37 recruiting
- Recruiting
Atlanta Gastroenterology Associates-Site Number: 8400109
Atlanta, Georgia, 30342
- Recruiting
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana, 70809
- Recruiting
Gateway Gastroenterology - Site Number: 8400097
Chesterfield, Missouri, 63017
- 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
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, 92118
- Recruiting
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina, 28304
- Recruiting
GI Alliance - Gurnee-Site Number:
Gurnee, Illinois, 60031
- Recruiting
Grand Teton Research Group, PLLC-Site Number: 8400127
Idaho Falls, Idaho, 83404
- Recruiting
One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125
Kingwood, Texas, 77339
- Recruiting
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida, 34741
- Recruiting
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058
Lexington, Kentucky, 40536-0293
- 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
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
Miami, Florida, 33155
- Recruiting
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana, 71291
- Recruiting
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, 92563
- 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
Lenox Hill Hospital-Site Number: 8400052
New York, New York, 10075
- Recruiting
New York Gastroenterology Associates - Site Number: 8400009
New York, New York, 10075
- Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
Pittsburgh, Pennsylvania, 15212
- Recruiting
University Gastroenterology-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 - Corporate Office - Site Number: 8400101
Southlake, Texas, 76092
- Recruiting
Premier Health Research, LLC-Site Number: 8400114
Sparta, New Jersey, 07871
- Recruiting
NMC Research LLC - Site Number: 8400033
Tampa, Florida, 33607
- Recruiting
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona, 85715
- 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
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California, 92395
- Recruiting
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, 44145
- Recruiting
UMass Memorial Medical Center-Site Number: 8400121
Worcester, Massachusetts, 01655
- Recruiting
Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming, Michigan, 49519
Japan23 sites, 23 recruiting
- Recruiting
Investigational Site Number : 3920059
Bunkyō City, 113-8655
- Recruiting
Investigational Site Number : 3920039
Chikushino-shi, 818-8502
- Recruiting
Investigational Site Number : 3920031
Hachiōji, 192-0032
- Recruiting
Investigational Site Number : 3920049
Kagoshima, 892-0843
- Recruiting
Investigational Site Number : 3920030
Kamakura, 247-0056
- Recruiting
Investigational Site Number : 3920018
Kashiwa, 277-0871
- Recruiting
Investigational Site Number : 3920019
Kobe, 650-0015
- Recruiting
Investigational Site Number : 3920033
Kōriyama, 963-8563
- Recruiting
Investigational Site Number : 3920051
Kumamoto, 860-0004
- Recruiting
Investigational Site Number : 3920007
Minato, 108-8642
- Recruiting
Investigational Site Number : 3920041
Nagaoka, 940-2085
- Recruiting
Investigational Site Number : 3920013
Nishinomiya, 663-8501
- Recruiting
Investigational Site Number : 3920002
Osaka, 540-0006
- Recruiting
Investigational Site Number : 3920014
Saga, 849-8501
- Recruiting
Investigational Site Number : 3920029
Sapporo, 004-0041
- Recruiting
Investigational Site Number : 3920042
Sapporo, 065-0033
- Recruiting
Investigational Site Number : 3920003
Sendai, 983-8520
- Recruiting
Investigational Site Number : 3920055
Takamatsu, 760-8557
- Recruiting
Investigational Site Number : 3920057
Takamatsu, 760-8557
- Recruiting
Investigational Site Number : 3920032
Toyama, 930-0194
- Recruiting
Investigational Site Number : 3920015
Toyohashi, 441-8570
- Recruiting
Investigational Site Number : 3920009
Tsu, 514-8507
- Recruiting
Investigational Site Number : 3920035
Yokohama, 232-0024
Poland21 sites, 21 recruiting
- Recruiting
Investigational Site Number : 6160026
Bydgoszcz, 85-229
- Recruiting
Investigational Site Number : 6160019
Bydgoszcz, 85-794
- 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 : 6160022
Krakow, 31-506
- Recruiting
Investigational Site Number : 6160034
Lublin, 20-049
- Recruiting
Investigational Site Number : 6160010
Opole, 45-819
- Recruiting
Investigational Site Number : 6160018
Poznan, 60-309
- Recruiting
Investigational Site Number : 6160025
Rzeszów, 35-326
- Recruiting
Investigational Site Number : 6160004
Sopot, 81-756
- Recruiting
Investigational Site Number : 6160007
Staszów, 28-200
- Recruiting
Investigational Site Number : 6160002
Szczecin, 71-434
- 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 : 6160005
Warsaw, 00-189
- Recruiting
Investigational Site Number : 6160008
Warsaw, 04-501
- Recruiting
Investigational Site Number : 6160006
Wroclaw, 52-416
- Recruiting
Investigational Site Number : 6160028
Wroclaw, 53-611
- Recruiting
Investigational Site Number : 6160017
Wroclaw, 54-239
France12 sites, 12 recruiting
- Recruiting
Investigational Site Number : 2500009
Amiens, 80054
- Recruiting
Investigational Site Number : 2500008
Besançon, 25000
- Recruiting
Investigational Site Number : 2500003
Créteil, 94000
- Recruiting
Investigational Site Number : 2500004
La Tronche, 38700
- Recruiting
Investigational Site Number : 2500010
Lille, 59000
- Recruiting
Investigational Site Number : 2500012
Marseille, 13015
- Recruiting
Investigational Site Number : 2500007
Nantes, 44000
- Recruiting
Investigational Site Number : 2500013
Nice, 6200
- Recruiting
Investigational Site Number : 2500001
Paris, 75018
- Recruiting
Investigational Site Number : 2500002
Saint-Priest-en-Jarez, 42270
- Recruiting
Investigational Site Number : 2500011
Toulouse, 31400
- Recruiting
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, 54500
Ukraine9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 8040003
Chernivtsi, 58001
- Recruiting
Investigational Site Number : 8040001
Kyiv, 2002
- Recruiting
Investigational Site Number : 8040002
Kyiv, 3037
- 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
- Recruiting
Investigational Site Number : 8040008
Vinnytsia, 21029
China8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 1560027
Beijing, 100195
- Recruiting
Investigational Site Number : 1560001
Chengdu, Sichuan, 610041
- Recruiting
Investigational Site Number : 1560002
Guangzhou, Guangdong, 510655
- Recruiting
Investigational Site Number : 1560028
Hefei, 230022
- Recruiting
Investigational Site Number : 1560026
Huizhou, Guangdong, 516001
- Recruiting
Investigational Site Number : 1560052
Kunming, 650032
- Recruiting
Investigational Site Number : 1560020
Shanghai, 200123
- Recruiting
Investigational Site Number : 1560018
Wuxi, Jiangsu, 214023
Georgia7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2680007
Kutaisi, 4600
- 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 : 2680002
Tbilisi, 160
- Recruiting
Investigational Site Number : 2680005
Tbilisi, 160
- Recruiting
Investigational Site Number : 2680009
Tbilisi, 178
Germany7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2760003
Berlin, 14163
- Recruiting
Investigational Site Number : 2760011
Halle, Saxony-Anhalt, 6108
- Recruiting
Investigational Site Number : 2760001
Kiel, Schleswig-Holstein, 24105
- Recruiting
Investigational Site Number : 2760015
Leipzig, Saxony, 4103
- Recruiting
Investigational Site Number : 2760010
Minden, 32423
- Recruiting
Investigational Site Number : 2760009
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Investigational Site Number : 2760005
Ulm, Baden-Wurttemberg, 89081
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, Ontario, M6A 3B4
South Korea5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 4100010
Ansan-si, 15355
- Recruiting
Investigational Site Number : 4100008
Busan, 48108
- Recruiting
Investigational Site Number : 4100004
Daegu, 42415
- Recruiting
Investigational Site Number : 4100006
Seoul, 6351
- Recruiting
Investigational Site Number : 4100005
Suwon, 16247
Chile3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1520004
Santiago, 7550000
- Recruiting
Investigational Site Number : 1520002
Santiago, 8320000
- Recruiting
Investigational Site Number : 1520001
Viña del Mar, 2540488
Hungary3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3480004
Budapest, 1066
- Recruiting
Investigational Site Number : 3480002
Budapest, H-1036
- Recruiting
Investigational Site Number : 3480001
Veszprém, 8200
Italy3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3800009
Rome, 152
- Recruiting
Investigational Site Number : 3800003
Rozzano, 20089
- Recruiting
Investigational Site Number : 3800005
Turin, 10128
Serbia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6880001
Belgrade, 11 000
- Recruiting
Investigational Site Number : 6880002
Belgrade, 11 080
- Recruiting
Investigational Site Number : 6880007
Belgrade, 11000
Slovakia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7030003
Košice, 040 13
- Recruiting
Investigational Site Number : 7030002
Prešov, 080 01
- Recruiting
Investigational Site Number : 7030004
Prešov, 080 01
South Africa3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7100002
Cape Town, 7405
- Recruiting
Investigational Site Number : 7100005
Claremont, 7708
- Recruiting
Investigational Site Number : 7100004
Durban, 3610
Austria2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0400003
Krems, Lower Austria, 3500
- Recruiting
Investigational Site Number : 0400002
Salzburg, 5020
Bulgaria2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1000003
Gorna Oryahovitsa, Oblast Veliko Tirnovo, 5100
- Recruiting
Investigational Site Number : 1000001
Sofia, 1618
Israel2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3760001
Jerusalem, 9103102
- Recruiting
Investigational Site Number : 3760002
Tel Aviv, 6423906
Lithuania2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 4400001
Kaunas, LT-50161
- Recruiting
Investigational Site Number : 4400002
Panevezys, 35144
Argentina1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0320007
Rosario, Santa Fe Province, 2000
Australia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0360001
South Brisbane, 4101
Belgium1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0560003
Yvoir, 5530
Czechia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2030011
Hradec Králové, 500 12
Greece1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 11527
Moldova1 site, 1 recruiting
- Recruiting
Investigational Site Number : 4980004
Chisinau, MD-2068
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280002
Amsterdam, 1081 HZ
Spain1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7240002
Huelva, 21005
Switzerland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7560001
Bern, 3012
Taiwan1 site, 1 recruiting
- Recruiting
Investigational Site Number : 1580001
Taoyuan City, 333
United Kingdom1 site, 1 recruiting
- Recruiting
Investigational Site Number : 8260001
London, SE1 9RT
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 Ulcerative Colitis
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
Study details include:
Read more
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 Pivotal Maintenance Sub-Study
- 240 weeks in OLE Sub-Study
The total number of on-site visit will be up to 32:
- 21 visits in the Pivotal Maintenance Sub-Study.
- 11 visits in the OLE Sub-Study.
- Conditions
- Ulcerative Colitis
- Being tested
- Duvakitug, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvakitugDrug
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 |
| Duvakitug - dose 2 | Experimental | SC injection as per protocol Receives: Drug: Duvakitug |
| Duvakitug - 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.
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
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)
Measured: Week 40
Secondary outcomes (16)
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.
Endoscopic improvement is defined as mMES of 0 or 1 (score of 1 excludes friability).
Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.
Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1.
The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.
Measured: Week 40
Proportion of participants with no bowel urgency.
The NRS for bowel urgency is a patient-reported tool designed to measure 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: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.
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 Tscores indicate greater fatigue.
Measured: Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.
Endoscopic remission is defined as mMES of 0.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission).
Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1.
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.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).
The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 ("no pain") to 10 ("worst possible pain").
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.
Measured: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis.
Measured: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.
Measured: Week 0 through 45 days after last dose
Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.
Measured: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Measured: Week 0 through Week 40
Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading 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 start16 Jan 2026
- Primary completion21 Sep 2028 (estimated)
- Study completion28 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- NCT07185009
- Sponsor's protocol ID
- EFC18359
- Other IDs
- 2025-521038-27, 2025
- Acronym
- SUNSCAPE-2
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 16 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 16 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 Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07185009
- Acronym / sponsor ID
- SUNSCAPE-2 / EFC18359
- Conditions
- Ulcerative Colitis
- 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
- 16 Jan 2026 (actual)
- Primary completion
- 21 Sep 2028 (estimated)
- Study completion
- 28 Apr 2033 (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 Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
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 Pivotal Maintenance Sub-Study
- 240 weeks in OLE Sub-Study
The total number of on-site visit will be up to 32:
- 21 visits in the Pivotal Maintenance Sub-Study.
- 11 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 |
| Duvakitug - dose 2 | Experimental | Drug: DuvakitugSC injection as per protocol |
| Duvakitug - 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 SUNSCAPE-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 participant'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 |
|---|---|---|
| DuvakitugPharmaceutical form: Injection solution Route of administration: SC injection | Drug | Duvakitug - dose 1, Duvakitug - dose 2, Duvakitug - dose 3 |
| PlaceboPharmaceutical form:Injection solution-Route of administration:SC injection | Drug | Placebo |
Primary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
Time frame: 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)
16 secondary outcomes
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.
Time frame: Week 40
Proportion of participants with no bowel urgency.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score.
Time frame: Baseline, Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission).
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS).
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis.
Time frame: Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.
Time frame: Week 0 through 45 days after last dose
Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.
Time frame: Week 0 through Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Time frame: Week 0 through Week 40
Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), TEAEs of Special Interest, Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading 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 16 Oct 2026.
- EFC18359 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
Related trials for Ulcerative Colitis
Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
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
171 sites in 31 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 Ulcerative Colitis, run by Sanofi at 171 sites in 31 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 16 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 171 sites in United States, Japan, Poland, France, Ukraine and 26 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?
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). (time frame: Week 40). 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 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.