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Recruiting NCT07184944

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Phase III Interventional Crohn's Disease

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: Crohn's Disease. 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, Moldova +2
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 Crohn's Disease

Overview

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

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

  • 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]
  • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40 [Time frame: 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 [Time frame: Week 40]
Secondary outcome measures (12)
  • 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]

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 STARSCAPE-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 patient'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 · 22 centers
  • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs
  • Clinical Research of Osceola-Site Number: 8400013 — Kissimmee
  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami
  • NMC Research LLC-Site Number: 8400033 — Tampa
  • Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany
  • GI Alliance - Baton Rouge-Site Number: 8400129 — Baton Rouge
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400 — Mandeville
  • Gateway Gastroenterology-Site Number: 8400097 — St Louis
  • … and 14 more centers
Georgia · 4 centers
  • Investigational Site Number : 2680008 — Tbilisi
  • Investigational Site Number : 2680003 — Tbilisi
  • Investigational Site Number : 2680005 — Tbilisi
  • Investigational Site Number : 2680002 — Tbilisi
Ukraine · 3 centers
  • Investigational Site Number : 8040005 — Lviv
  • Investigational Site Number : 8040010 — Vinnytsia
  • Investigational Site Number : 8040009 — Vinnytsia
Canada · 2 centers
  • Investigational Site Number : 1240009 — Hamilton
  • Investigational Site Number : 1240003 — Toronto
Moldova · 2 centers
  • Investigational Site Number : 4980003 — Chisinau
  • Investigational Site Number : 4980004 — Chisinau
Japan · 1 center
  • Investigational Site Number : 3920009 — Tsu
South Africa · 1 center
  • Investigational Site Number : 7100001 — Kempton Park

Identifiers

NCT: NCT07184944 · EFC18327 · 2025-521037-86 · U1111-1314-5471

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗