A Study to Evaluate the Efficacy Safety and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    270
  • sponsor
    Genentech, Inc.
Updated on 26 May 2021
Carolina Digestive Diseases (2.7 mi away) Contact
remission
methotrexate
tumor necrosis factor
mercaptopurine
vedolizumab
azathioprine
tumour necrosis

Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Vedolizumab, UTTR1147A, Vedolizumab Placebo, UTTR1147A Placebo
Clinical Study IdentifierNCT03558152
SponsorGenentech, Inc.
Last Modified on26 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of UC
Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
Use of highly effective contraception as defined by the protocol

Exclusion Criteria

History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
History of cancer as defined by the protocol
Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
Prior treatment with UTTR1147A
Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
Prior treatment with rituximab
Use of prohibited therapies, as defined by the protocol, prior to randomization
Congenital or acquired immune deficiency
Evidence or treatment of infections or history of infections, as defined by the protocol
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

Phone Email

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