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Oral Etrasimod for Crohn's Disease (CULTIVATE Trial)
CULTIVATE Trial Summary
This trial is testing a new drug for Crohn's disease in adults who haven't had success with other treatments. The study will last about 5 and a half years, and will assess the drug's efficacy, safety, and tolerability.
CULTIVATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCULTIVATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 42 Patients • NCT04706793CULTIVATE Trial Design
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- My Crohn's disease is currently moderate to severe.I have Crohn's disease and treatments like steroids, immunosuppressants, or biologics didn’t work for me.You have a surgical opening in your abdomen to help eliminate waste.I have been diagnosed with Crohn's disease for at least 3 months.I have short-bowel syndrome that might need surgery or affect treatment results.I am between 18 and 80 years old.I am not pregnant and can have children.I am not pregnant and can have children.My Crohn's disease is currently moderate to severe.I am between 18 and 80 years old.
- Group 1: Etrasimod Dose A
- Group 2: Placebo
- Group 3: Etrasimod Dose B
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To date, how many individuals have signed up for this clinical trial?
"A total of 1265 patients are needed for this clinical trial, which is currently ongoing at multiple locations. To participate, patients must meet the specified inclusion criteria. For example, GI Alliance - Webster in Webster, Texas and Latashia Hundley, CCRC in Jacksonville, Florida are both active sites recruiting patients for this study."
Are participants still being recruited for this research project?
"That is accurate. The listing on clinicaltrials.gov does show that this study needs more participants and was last updated on 11/7/2022. The research trial was first advertised on 2/12/2020 and is looking for 1265 patients in total, at 73 different sites."
Does this clinical trial break new ground in the medical field?
"Etrasimod is being trialed in 7 different ongoing studies across 368 cities and 50 countries. The first study began in 2019 and was completed in Phase 3 by Arena Pharmaceuticals. A total of 912 patients were involved. Since then, 18290 similar studies have been conducted."
Are there other clinical trials that compare Etrasimod to other drugs?
"Etrasimod is being trialled in 7 active studies, 3 of which are Phase 3 trials. Most of these trials are concentrated in Región, Gyeonggi-do but there are 1129 total locations for the trials worldwide."
Are minors included in the scope of this research project?
"The eligible age range for this particular trial is 18 to 80 years old. There are a total of 70 trials underway for patients that are younger than 18 and 206 trials for patients 65 or older."
Could you explain who would make a good candidate for this clinical trial?
"This research is seeking 1265 individuals, both male and female, aged 18 to 80 that have ileocolitis. In addition, the following must be true of potential participants: They must have moderately to severely active CD at Screening, Females of childbearing potential must be nonpregnant."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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