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Recruiting NCT07185009

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Phase III Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Duvakitug, Placebo.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 16 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Georgia, Japan, Lithuania +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Duvakitug
    Pharmaceutical form: Injection solution Route of administration: SC injection
  • Drug Placebo
    Pharmaceutical form:Injection solution-Route of administration:SC injection

Primary outcome measures

  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). [Time frame: Week 40]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Del Sol Research Management, LLC - Site Number: 8400012 — Tucson
  • Southern California GI & Liver Centers - Site Number: 8400062 — Coronado
  • United Medical Doctors CA - Site Number: 8400044 — Murrieta
  • Om Research, LLC - Victorville - Site Number: 8400022 — Victorville
  • Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs
  • Royal Palm Clinical Research - Site Number: 8400065 — Fort Myers
  • Clinical Research of Osceola - Site Number: 8400013 — Kissimmee
  • Bioresearch Partner-Kendale Lakes - Site Number: 8400053 — Miami
  • … and 20 more centers
Japan · 6 centers
  • Tokai University Hachioji Hospital - Site Number : 3920031 — Hachiōji
  • Investigational Site Number : 3920049 — Kagoshima
  • Investigational Site Number : 3920030 — Kamakura
  • Investigational Site Number : 3920019 — Kobe
  • Investigational Site Number : 3920029 — Sapporo
  • Investigational Site Number : 3920009 — Tsu
Ukraine · 5 centers
  • Investigational Site Number : 8040001 — Kyiv
  • Investigational Site Number : 8040002 — Kyiv
  • Investigational Site Number : 8040005 — Lviv
  • Investigational Site Number : 8040006 — Uzhhorod
  • Investigational Site Number : 8040008 — Vinnytsia
Canada · 2 centers
  • Investigational Site Number : 1240003 — Toronto
  • Charlton Digestive Disease Centre - Site Number : 1240009 — Hamilton
Serbia · 2 centers
  • Investigational Site Number : 6880001 — Belgrade
  • Investigational Site Number : 6880002 — Belgrade
Georgia · 1 center
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002 — Tbilisi
Lithuania · 1 center
  • Investigational Site Number : 4400002 — Panevezys
Poland · 1 center
  • SONOMED - Site Number : 6160020 — Szczecin

Identifiers

NCT: NCT07185009 · EFC18359 · 2025-521038-27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗