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RecruitingPhase 3

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

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The treatment duration will be up to 12 weeks in each sub-study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well duvakitug works and how safe it is for people with moderate to severe active Crohn’s disease. It is for people whose past treatments did not work well, stopped working, or caused side effects they could not tolerate. The study may last up to 35 weeks.

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old at screening. In places where it is allowed, people ages 16 or 17 may join if they have fully completed puberty.
  • You have had a confirmed diagnosis of moderate to severe active Crohn’s disease for at least 3 months before starting the study.
  • Standard or advanced treatments did not work well, stopped working, or caused side effects you could not tolerate.

Who can't join

  • You have ulcerative colitis or colitis of an unclear type. These are other types of bowel inflammation.
  • You are missing two whole sections of the bowel from the sections listed in the study rules.
  • You have or have had high-grade dysplasia in your digestive tract. These are very abnormal cells that may turn into cancer.
  • You are taking standard treatment, but your doses have not been stable before starting the study.
  • You are receiving medicines or treatments that the study does not allow.
  • You have previously received an experimental anti-TL1A treatment, which targets a protein involved in inflammation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development * Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline * Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs) Exclusion Criteria: * Participants with Ulcerative Colitis (UC) or indeterminate colitis * Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum * Prior or current high-grade gastrointestinal (GI) dysplasia * Participants on treatment with but not on stable doses of conventional therapy prior to baseline * Participants receiving prohibited medications or therapies * Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study sites (125)

AR

AZ

CA

CO

CT

FL

GA

IA

ID

IL

IN

KS

KY

  • University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058 · Lexington, KY 40536-0293More trials in Lexington

LA

MA

MD

MI

  • Henry Ford Medical Center - Columbus-Site Number: 8400118 · Novi, MI 48377More trials in Novi
  • Gastroenterology Associates of Western Michigan-Site Number: 8400060 · Wyoming, MI 49519More trials in Wyoming

MO

MS

  • Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007 · Jackson, MS 08527More trials in Jackson

NC

ND

NJ

NV

NY

OH

OK

OR

PA

RI

SC

TN

TX

UT

VA

WA

WI

  • Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081 · Milwaukee, WI 53226More trials in Milwaukee