Ulcerative Colitis
Duvakitug Maintenance Study for Moderately to Severely Active Ulcerative Colitis
This Phase 3 study is evaluating the effects and safety of injected duvakitug as maintenance treatment for people with moderately to severely active ulcerative colitis who completed a qualifying earlier study.
Registry title: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
28 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 participants with moderately to severely active ulcerative colitis, how does duvakitug maintenance treatment compare with placebo for clinical remission and safety?
Participant snapshot
Who the study is looking for
- The study is looking for people with moderately to severely active ulcerative colitis.
- Participants are generally 18 to 80 years old; where locally permitted, people aged 16 to under 18 must have reached Tanner stage 5.
- For the pivotal maintenance sub-study, participants must have achieved a clinical response and completed an endoscopy at the end of SUNSCAPE-1.
- For the open-label extension, participants must complete the pivotal maintenance sub-study or participation in study TV48574-IMM-20038.
Participation overview
What participation may involve
Participation may include a 40-week pivotal maintenance sub-study followed by a 240-week open-label extension. Participants who do not enter the extension have a follow-up visit 45 days after the maintenance period. What participation may involve: - Participants receive subcutaneous injections of duvakitug or placebo during the pivotal maintenance study. - Ulcerative colitis activity is assessed using symptoms and the modified Mayo Score, including stool frequency, rectal bleeding, and endoscopic findings. - The study assesses endoscopic and tissue-level improvement, patient-reported bowel urgency, fatigue, abdominal pain, quality of life, hospitalizations, and steroid-free remission. - Safety events, serum duvakitug concentrations, and anti-drug antibodies are monitored. Total participation may last up to 286 weeks, including 40 weeks of pivotal maintenance, 240 weeks of open-label extension, and follow-up. Without the extension, participation may last up to 46 weeks. The registry reports up to 32 on-site visits: 21 during pivotal maintenance and 11 during the open-label extension.
Study interventions
What participants may receive or do
- Duvakitug: Duvakitug is given as a subcutaneous injection. The pivotal maintenance study includes three duvakitug dose groups, but the registry does not state the doses.
- Placebo: The placebo is given as a subcutaneous injection and serves as the comparison intervention.
Study design
How the comparison works
This is a Phase 3, parallel-group maintenance study with duvakitug dose groups and a placebo group. It also includes a 240-week open-label extension sub-study. Participants in the pivotal maintenance study are assigned randomly among parallel treatment groups. The pivotal maintenance study uses quadruple masking: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. Outcomes in three duvakitug dose groups are compared with outcomes in a placebo group. One pivotal maintenance group receives placebo by subcutaneous injection; the registry does not report each participant's probability of receiving placebo.
Reported activities
Procedures and tests
- Subcutaneous study injections are given according to the protocol.
- Endoscopy is used to assess improvement or remission, with images evaluated by a blinded central reader.
- Intestinal tissue findings are assessed using the Geboes histology score together with endoscopic findings.
- Stool frequency and rectal bleeding are recorded as components of ulcerative colitis activity and remission assessments.
- Participants report bowel urgency and abdominal pain using 0-to-10 numerical rating scales.
- Fatigue is assessed with the seven-item Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a.
- Quality of life is assessed with the Inflammatory Bowel Disease Questionnaire.
- Serum duvakitug concentrations and anti-drug antibodies against duvakitug are measured over time.
- Treatment-emergent adverse events, serious adverse events, events of special interest, and events leading to permanent discontinuation are monitored.
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 must generally be 18 through 80 years old at baseline.
- Where locally permitted, participants aged 16 to under 18 must meet the definition of Tanner stage 5 development.
- Entry into the pivotal maintenance sub-study requires clinical response and completion of an endoscopy at the end of SUNSCAPE-1.
- Entry into the open-label extension requires completion of the pivotal maintenance sub-study or participation in study TV48574-IMM-20038.
Possible reasons someone may not be able to join
- The investigator may exclude someone because of a medical or study-compliance condition considered unsuitable for participation.
- A known hypersensitivity to duvakitug may exclude someone if the investigator considers it unsuitable for participation.
Important unknowns
What the record does not make clear
- The registry gives the maximum number of on-site visits but not their timing or length.
- The registry lists three duvakitug dose groups and one placebo group but does not report the allocation ratio.
- The record does not state which ulcerative colitis medicines may be continued during the study.
- The record does not describe medication washout or timing requirements.
- The record does not explain what treatment is available if ulcerative colitis worsens.
- The record does not distinguish research-covered costs from costs billed to participants or insurance.
- The record does not report whether participants receive compensation.
- The record does not report whether travel expenses or lodging are supported.
- The registry reports on-site visits but does not say whether any activities can be completed remotely.
- The record does not describe access to duvakitug after study participation ends.
- The study is recruiting and lists recruiting sites, but the record does not establish whether each sub-study or cohort has openings at a particular site.
Before contacting the site
Questions for the study team
- Which sub-study and cohort would apply to me, and is it currently enrolling at my preferred site?
- What is the chance of assignment to each duvakitug dose group or placebo?
- What is the complete visit schedule, and what happens at each visit?
- Which current ulcerative colitis medicines may continue, and are any washout periods required?
- What happens if ulcerative colitis symptoms worsen during the study?
- Which endoscopies and tissue samples are required after enrollment, and will sedation be used?
- Which costs are covered, and are compensation or travel support available?
- What treatment options are available after study treatment ends?
Before changing care
Questions for your gastroenterologist
- How might the study's treatment plan affect the ulcerative colitis medicines I currently use?
- How stable is my ulcerative colitis now, and what signs would make study participation medically concerning?
- What approved treatment alternatives should I compare with the study's duvakitug and placebo groups?
- Are there risks from injections, endoscopies, treatment interruption, or my other health conditions that are especially relevant to me?
- How should my gastroenterology team and the research team coordinate routine care, flare management, and study assessments?
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 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 and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- EFC18359
- 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
Duvakitug - dose 2
SC injection as per protocol
Interventions: Drug: Duvakitug
Experimental
Duvakitug - 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 SUNSCAPE-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 participant's potential participation in a clinical trial.Registry-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
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)
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement.
Time frame: Week 40
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).
Secondary outcome
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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission.
Time frame: Week 40
Secondary outcome
Proportion of participants with no bowel urgency.
Time frame: Week 40
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".
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in 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 US national norms. Higher Tscores indicate greater fatigue.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission.
Time frame: Week 40
Endoscopic remission is defined as mMES of 0.
Secondary outcome
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
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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (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").
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score
Time frame: Week 40
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.
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations.
Time frame: Week 0 through Week 40
Secondary outcome
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
Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
Secondary outcome
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
Secondary outcome
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
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time.
Time frame: Week 0 through Week 40
Secondary outcome
Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Time frame: Week 0 through Week 40
Secondary outcome
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
Recruiting locations in the United States
Del Sol Research Management, LLC - Site Number: 8400012
RecruitingTucson, Arizona, 85715, United States
Southern California GI & Liver Centers - Site Number: 8400062
RecruitingCoronado, California, 92118, United States
United Medical Doctors CA - Site Number: 8400044
RecruitingMurrieta, California, 92563, United States
Om Research, LLC - Victorville - Site Number: 8400022
RecruitingVictorville, California, 92395, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
RecruitingColorado Springs, Colorado, 80907, United States
Royal Palm Clinical Research - Site Number: 8400065
RecruitingFort Myers, Florida, 33901, United States
Clinical Research of Osceola - Site Number: 8400013
RecruitingKissimmee, Florida, 34741, United States
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
RecruitingMiami, Florida, 33155, 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
Delta Research Partners - Site Number: 8400087
RecruitingMonroe, Louisiana, 71291, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060
RecruitingWyoming, Michigan, 49519, United States
Gateway Gastroenterology - Site Number: 8400097
RecruitingChesterfield, Missouri, 63017, United States
BVL Clinical Research - Site Number: 8400005
RecruitingLiberty, Missouri, 64068, 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
Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040
RecruitingNew York, New York, 10065, 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
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
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101
RecruitingSouthlake, Texas, 76092, United States
Tyler Research Institute, LLC - Site Number: 8400095
RecruitingTyler, Texas, 75701, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RecruitingVancouver, Washington, 98664, United States
This study also lists 18 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
- Sep 21, 2028
- Overall completion
- Apr 28, 2033
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.