A Multicenter Randomized Double-Blind Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Apr 20, 2023
  • participants needed
    1547
  • sponsor
    AbbVie
Updated on 1 August 2021
remission

Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment placebo for risankizumab, risankizumab IV, risankizumab SC, placebo for rizankizumab, rizankizumab SC
Clinical Study IdentifierNCT03398148
SponsorAbbVie
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline
Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore
Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies
Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control

Exclusion Criteria

Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis
Participant receiving prohibited medications and treatment
Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy
Participant with currently known complications of UC (e.g., megacolon)
No known active Coronavirus Disease - 2019 (COVID-19) infection
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...

Browse trials for

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