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 (ARTEMIS)

Clinical Trial Details

The purpose of this research study is to determine whether the study drug, PRA023, is safe and effective for ulcerative colitis (UC), by comparing it to placebo (a pill with no active ingredients).

PRA023 is a monoclonal antibody, which is a man-made antibody that acts like human antibodies in your immune system, that may reduce inflammation and fibrosis associated with inflammatory bowel disease, such as UC and Crohn’s disease.

PRA023 is considered investigational, which means it has not yet been approved by the U.S. Food and Drug Administration (FDA).

Participants in this study will be randomized to receive either PRA023 or placebo. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participation will last for 12 weeks. After the completion of the 12-week period, all participants have the option to continue for another 38 weeks.

Key Eligibility:

Inclusion Criteria:

Confirmed diagnosis of ulcerative colitis (UC)
Moderately to severely active UC

Exclusion Criteria:

Unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug
Diagnosis of Crohn's disease or indeterminate colitis
Current or impending need for colostomy or ileostomy, or surgical bowel resection within 3 months before screening

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Randy Longman, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2109023984

ClinicalTrials.gov:

NCT04996797

Status

Open to Enrollment

Age Group

Adult

Disease

Ulcerative Colitis