The Scarlet Study for Adults with Moderately to Severely Active Crohn’s Disease

Last updated: June 4, 2021
Sponsor: Janssen Research
Overall Status: Active - Recruiting

Phase

2

Condition

Crohn's Disease

Crohn's Disease (Pediatric)

Treatment

N/A

Clinical Study ID

TX272669
67864238PACRD2001
  • Ages 18-75
  • All Genders

Study Summary

Before beginning the study, patients must go through a screening process to see if they meet the study eligibility requirements. The Screening Period will last about 5 weeks and includes tests and assessments performed at the study clinic.

Patients who are eligible for this study will be randomly assigned (like the flip of a coin) to receive the investigational medication or placebo. Placebo looks like the investigational medication but contains no active medication. Patients, the study doctor, and study staff will not know the medication assignments. However, in the event of an emergency, this information can be provided.

All patients will take their study medication (investigational or placebo) twice a day for 12 weeks. After patients stop taking their study medication, they will return to the study clinic for a final Safety Follow-Up visit. Total participation in this study will last approximately 21 weeks, which includes up to 7 study clinic visits for tests and assessments.

Clinical Study Identifier: 67864238PACRD2001

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • .18 to 75 years of age

  • Diagnosed with Crohn’s disease for at least 3 months

  • Have moderately to severely active Crohn’s disease

Exclusion

Exclusion Criteria:

    • Have complications of Crohn’s disease that might require surgery
  • Currently have or suspected to have an abscess
  • Had any kind of bowl resection within 6 months of beginning the study or any other intra-abdominal surgery within 3 months of beginning the study

Study Design

Study Start date:
May 04, 2021
Estimated Completion Date:

Study Description

_If you would like to learn more about the Scarlet study and clinical research, please visit

www.PRISMCrohns.com.

_

You will also have the opportunity to take a pre-screening questionnaire to find out if you may meet the study eligibility requirements.