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Tests treatment safety and results for Ulcerative Colitis
Official title A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07185009
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 ulcerative colitis.
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 multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 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.
- 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 SUNSCAPE-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's taking place
- Tucson, Arizona, United States
- Coronado, California, United States
- Murrieta, California, United States
- Victorville, California, United States
- Colorado Springs, Colorado, United States
- Fort Myers, Florida, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- New Albany, Indiana, United States
- Baton Rouge, Louisiana, United States
- Mandeville, Louisiana, United States
- Monroe, Louisiana, United States
- Wyoming, Michigan, United States
- Chesterfield, Missouri, United States
- Liberty, Missouri, United States
- Maspeth, New York, United States
- New York, New York, United States
- Fayetteville, North Carolina, United States
- Columbus, Ohio, United States
+ 22 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 Tucson, Arizona, United States; Coronado, California, United States; Murrieta, California, United States; Victorville, California, United States; Colorado Springs, Colorado, United States; Fort Myers, Florida, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.