A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of Oral Ozanimod As Induction Therapy For Moderately To Severely Active Crohn’s Disease

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

Other studies available to continue treatment later after the initial 12 weeks period.

 

Description

All study related tests, exams, colonoscopy and medication will be provided free of charge. There is compensation for time and travel

Details
Condition Crohn's Disease
Clinical Study IdentifierTX228690
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study
Aged 12-75 years
Crohn's disease for ≥ 3 months on endoscopy and on histological exam
Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
Patient has met each of the following clinical and endoscopic criteria
Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease)

Exclusion Criteria

Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgement, surgical or medical intervention within 12 weeks of entry into the study, or need for ileostomy or colostomy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note