Induction Therapy with PRA023 in Ulcerative Colitis

Summary

This study focuses on individuals with ulcerative colitis (UC) that has been assessed as being moderate to severe. The purpose of the study is to determine whether an investigational drug called PRA023 is safe and effective in treating UC. PRA023 is a monoclonal antibody (man-made antibodies that act like human antibodies in the immune system) that may reduce inflammation and fibrosis associated with inflammatory bowel disease, such as UC and Crohn’s disease. Participants will be randomly assigned to received either PRA023 or placebo (inactive substance).


Inclusion Criteria

  • Confirmed diagnosis of ulcerative colitis (UC)
  • Moderately to severely active UC as defined by 3-component Modified Mayo score
  • Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-TNF, anti-integrin, anti-IL12/23, JAK inhibitor, S1PR modulator.
  • Able to provide written informed consent and understand and comply with the requirements of the study.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis

Details
Disease Type/Condition

Other

Principal Investigator

Melmed, Gil

Co-Investigators

Andrea Banty, Susie Lee

Age Group

Adult

Phase

II

IRB Number

STUDY00001598

ClinicalTrials.gov ID

NCT04996797

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Melmed, Gil

Age Group

Adult

Phase

II

IRB Number

PR200-102

ClinicalTrials.gov ID

NCT04996797

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?