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Sphingosine 1-phosphate receptor modulator

Oral Etrasimod for Crohn's Disease (CULTIVATE Trial)

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women 18 to 80 years of age
Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4
Awards & highlights

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.

Who is the study for?
Adults aged 18-80 with moderate to severe Crohn's Disease, who haven't responded well to or can't tolerate steroids, immunosuppressants, or biologics. They must be able to follow the study plan and use contraception if they can have children.Check my eligibility
What is being tested?
The trial is testing Etrasimod, an oral medication for Crohn's Disease. It compares Etrasimod against a placebo over several years to check its effectiveness and safety in those not helped by standard treatments.See study design
What are the potential side effects?
Possible side effects of Etrasimod include headache, nausea, respiratory infections, high blood pressure, and potential impacts on liver function. The exact side effects will be monitored throughout the trial.

CULTIVATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been diagnosed with Crohn's disease for at least 3 months.
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My Crohn's disease is currently moderate to severe.
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I am not pregnant and can have children.

CULTIVATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
Proportion of Participants With Endoscopic Response [Substudy 1]
+3 more
Secondary outcome measures
Change From Baseline in CDAI Score [Substudy A]
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]
Change from baseline in CD-PRO/SS [Substudy 2]
+16 more

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793
14%
Headache
11%
Malaise
11%
Pyrexia
7%
Vaccination site pain
7%
Colitis ulcerative
4%
Back pain
4%
Contusion
4%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: Etrasimod 2 mg

CULTIVATE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Etrasimod Dose BExperimental Treatment1 Intervention
Group II: Etrasimod Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrasimod
2020
Completed Phase 3
~1350

Find a Location

Who is running the clinical trial?

Arena is a wholly owned subsidiary of PfizerUNKNOWN
10 Previous Clinical Trials
1,530 Total Patients Enrolled
PfizerLead Sponsor
4,562 Previous Clinical Trials
10,906,466 Total Patients Enrolled
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
4,761 Total Patients Enrolled

Media Library

Etrasimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04173273 — Phase 3
Crohn's Disease Research Study Groups: Etrasimod Dose A, Placebo, Etrasimod Dose B
Crohn's Disease Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT04173273 — Phase 3
Etrasimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173273 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
RecioMed Clinical Research Network, Inc
Grady Memorial Hospital
Duke Health's Brier Creek Medical Pavilion (recruitment and study activities)

Why did patients apply to this trial?

Recently i have has numerous flare-ups although I'm using Humira weekly.
PatientReceived 1 prior treatment
~489 spots leftby Jul 2027