An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Aug 5, 2027
  • participants needed
    702
  • sponsor
    Arena Pharmaceuticals
Updated on 5 August 2021

Summary

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blinded treatment (either etrasimod 2 mg per day or placebo) during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either Study APD334-301 or APD334-302).

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Etrasimod
Clinical Study IdentifierNCT03950232
SponsorArena Pharmaceuticals
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria
Participants previously enrolled in Study APD334-301 must have completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline or completed the Week 52 visit
Participants previously enrolled in APD334 302 must have completed the Week 12 visit

Exclusion Criteria

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
Experienced an adverse event that led to discontinuation from one of the parent studies
Clear my responses

How to participate?

Step 1 Connect with a site
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
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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