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
A maintenance study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active ulcerative colitis
(SUNSCAPE-2)
Obara Kentaro
Sanofi K.K.
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
+81-3-6301-3670
clinical-trials-jp@sanofi.com
Clinical Study Unit
Sanofi K.K.
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
+81-3-6301-3670
clinical-trials-jp@sanofi.com
Recruiting
April. 14, 2026
April. 21, 2026
751
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
- 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.
- Open-Label Extension (OLE) Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study.
- 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.
Study Arms:
- Experimental: Duvakitug - dose 1
SC injection as per protocol.
- - Interventions: Duvakitug
- Experimental: Duvakitug - dose 2
SC injection as per protocol.
- - Interventions: Duvakitug
- Experimental: Duvakitug - dose 3
SC injection as per protocol.
- - Interventions: Duvakitug
- Placebo Comparator: Placebo
SC injection as per protocol.
- - Interventions: Placebo
1. 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 ulcerative colitis (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 stool-frequency sub score (SFS) of 0 or 1, rectal bleeding sub score (RBS) of 0, and Mayo Endoscopic Subscore (MES) of 0 or 1 (score of 1 modified to exclude friability).
1. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement
[Time Frame: Week 40]
Endoscopic improvement is defined as MES 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).
2. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement
[Time Frame: Week 40]
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.
3. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission
[Time Frame: Week 40]
4. Proportion of participants with no bowel urgency
[Time Frame: Week 40]
The Numerical Rating Scale (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".
5. Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score
[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 United States (US) national norms. Higher T-scores indicate greater fatigue.
6. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission
[Time Frame: Week 40]
Endoscopic remission is defined as MES of 0.
7. 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]
Refer to the primary outcome for the "clinical remission".
8. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by NRS
[Time Frame: Week 40]
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").
9. Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
[Time Frame: Baseline, Week 40]
IBDQ is a tool to the quality of life of individuals suffering from inflammatory bowel disease (IBD). The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.
10. Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations
[Time Frame: Week 0 through Week 40]
11. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (SFS and RBS) response
[Time Frame: Week 40]
Symptomatic response is defined as >=30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
12. 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]
13. Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation
[Time Frame: Week 0 through 45 days after last dose]
14. Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time
[Time Frame: Week 0 through Week 40]
15. Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug
[Time Frame: Week 0 through Week 40]
16. OLE Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent study intervention discontinuation
[Time Frame: Week 40 of pivotal Maintenance through 45 Days after last dose]
Sanofi K.K.
Tokushukai Group Institutional Review Board
1-3-1 Kudan Minami, Chiyoda-ku, Tokyo
Approval
Nov. 20, 2025
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
NCT07185009
ClinicalTrials.gov
2025-521038-27
CTIS
United States/Canada/Georgia/Lithuania/Poland/Serbia/Ukraine/France/Germany/Hungary
