VIVID-1, a clinical research study for adults 18–80 with moderately to severely active Crohn’s disease.

  • STATUS
    Recruiting
Updated on 13 September 2021
Investigator
VIVID-1 Study Center
Primary Contact
VIVID-1 Study Center (6.7 mi away) Contact
+76 other location
gastrointestinal diseases
gastrointestinal disorder
inflammatory bowel disease
crohn's disease

Summary

A phase 3 research study of an injectable investigational medicine for adults ages 18 to 80 with moderate to severe Crohn’s disease.

Note that study participants may receive the investigational medication, a currently approved Crohn’s medication, or placebo.

The study comprises four periods: screening, treatment period 1, treatment period 2, and final safety follow-up.

Description

A special website has been created to provide more information about the VIVID-1 study. The website can help determine if you may qualify and includes information on what to expect if you are enrolled. Visit VIVID-1.com to see if you may qualify.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Irritable Bowel Syndrome (IBS), Gastrointestinal Diseases and Disorders, Crohn's Disease (Pediatric)
Clinical Study IdentifierTX240329
Last Modified on13 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be 18-80 years of age
Have had moderate to severe CD for at least three months' duration, as assessed by SF, AP score, and SES-CD
Demonstrated intolerance, loss of response, or inadequate response to conventional or biologic therapy for CD
If female, subject must meet the contraception recommendations

Exclusion Criteria

Have a current diagnosis of ulcerative colitis, inflammatory bowel disease - unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess, or short bowel syndrome
Have a stoma or ostomy
Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra-abdominal surgery within 3 months of baseline
Have ever received any monoclonal antibodies binding IL-23
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.

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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.

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

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