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RecruitingPhase 3

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

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 Ulcerative Colitis.

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

  • Visits mentioned: 15 visits

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 number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction."
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 moderately to severely active ulcerative colitis, a disease that causes swelling and sores in the large bowel. It is for adults ages 18 to 80 and, where local rules allow, some teens ages 16 to 17 whose bodies are fully developed. The study may last up to 35 weeks.

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * 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) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

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. Where local rules allow, teens ages 16 to 17 may join if their bodies are fully developed (Tanner Stage 5).
  • You have had a confirmed diagnosis of moderately to severely active ulcerative colitis for at least 3 months before starting the study.
  • Standard or advanced treatments did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • You have Crohn’s disease or colitis whose type is unclear.
  • You currently have ulcerative proctitis, a form of colitis limited to the rectum.
  • You had surgery to remove part of your bowel within the past 3 months, or have had this surgery more than 3 times.
  • You have or have had high-grade gastrointestinal dysplasia, meaning very abnormal cells in your digestive tract.
  • You take standard treatments, but their doses have not been stable before starting the study.
  • You used medicines or treatments before starting the study that the study does not allow.
  • You have previously received an experimental anti-TL1A treatment.

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 UC for at least 3 months prior to Baseline * Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies Exclusion Criteria: * Participants with Crohn's Disease (CD), indeterminate colitis * Current diagnosis of Ulcerative Proctitis * Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections * Prior or current high-grade gastrointestinal (GI) dysplasia * Participants on treatment with but not on stable doses of conventional therapies prior to baseline * Participants with prohibited medications or therapies prior to baseline * 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 (118)

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

  • Gastroenterology Associates of Western Michigan - Site Number: 8400060 · Wyoming, MI 49519More trials in Wyoming

MO

NC

ND

NJ

NV

NY

OH

OK

OR

  • Oregon Health & Science University, Center for Health and Healing 2 - Site Number: 8400131 · Portland, OR 97239-3098More trials in Portland

PA

  • Penn State Milton S. Hershey Medical Center - Site Number: 8400066 · Hershey, PA 17033-0850More trials in Hershey
  • University of Pennsylvania School of Medicine - Site Number: 8400072 · Philadelphia, PA 19104-6243More trials in Philadelphia
  • The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107 · Pittsburgh, PA 15212More trials in Pittsburgh

RI

SC

TX

UT

VA

WA