Crohn's Disease study: Duvakitug
Official title A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07184944
What this study is testing
What is Duvakitug?
An investigational once‑daily subcutaneous injection being studied 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
- The study aims to see if duvakitug is safe and effective at maintaining disease control over a long period.
- Who it's for
- Adults with moderately to severely active Crohn’s disease who have not yet tried this medication.
- What's involved
- Participants will receive either duvakitug or a placebo for 40 weeks, then may continue in an open‑label extension for up to 240 weeks. They will have regular clinic visits and medical tests to monitor safety and disease activity.
- Time commitment
- The total study can last up to 286 weeks, with up to 43 on‑site visits, including 21 visits during the 40‑week maintenance phase and 22 visits during the extension.
- 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 Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of...
- 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
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Colorado Springs, Colorado, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Gurnee, Illinois, United States
- New Albany, Indiana, United States
- Baton Rouge, Louisiana, United States
- Mandeville, Louisiana, United States
- Metairie, Louisiana, United States
- Monroe, Louisiana, United States
- Liberty, Missouri, United States
- St Louis, Missouri, United States
- Maspeth, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Fayetteville, North Carolina, United States
- Columbus, Ohio, United States
- Westlake, Ohio, United States
- Philadelphia, Pennsylvania, United States
+ 72 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, but 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?
This study is enrolling now at Colorado Springs, Colorado, United States; Kissimmee, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Gurnee, Illinois, United States and 86 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.