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Tests treatment safety and results for Crohn's Disease
Official title An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07184931
What this study is testing
What is Duvakitug?
Duvakitug is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn's disease.
Also referred to as SAR447189.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 80
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Coronado, California, United States
- Folsom, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Rancho Cucamonga, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Tarzana, California, United States
- Thousand Oaks, California, United States
- Valencia, California, United States
- Victorville, California, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Clermont, Florida, United States
- Coral Springs, Florida, United States
+ 224 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Canoga Park, California, United States; Coronado, California, United States and 238 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.