Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

A Phase 2A, Randomized, Double-Blind, Placebo-controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The Spring Study

Clinical Trial Details

The purpose of this research study is to find out the safety, tolerability, and impact of the study drug CM-101 in adult patients with Primary Sclerosing Cholangitis (PSC). In Primary Sclerosing Cholangitis, it is thought that some substances released in excess by the body induce the migration of various kind of cells to your liver, leading to liver damage. CM-101 is an investigational drug that is believed to be able to block the activity of these substances and thus limit the liver damage. 
   
Investigational means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) for sale in the United States or by any regulatory authorities in any country in the world. Experimental drugs such as CM-101 may be tested in research studies such as this one.
   
Participants will be randomized to receive either CM-101 or placebo. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. The placebo will look like CM-101 but will not contain active ingredients.
   
Participation in this study will last approximately 31 weeks and participants will be compensated for their time. 

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with primary sclerosing cholangitis (PSC).

Detailed eligibility reviewed when contacting the study team.
   

 

Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
(646) 962-4040
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2203024491

ClinicalTrials.gov:

NCT04595825

Sponsor:

CM-101-PSC-101

Status

Open to Enrollment

Age Group

Adult

Sponsor