The Latest

  • COUR Pharmaceuticals Announces FDA Clearance of Investigational New Drug Application for Myasthenia Gravis
  • Skip to primary navigation
  • Skip to main content
  • Skip to footer
COUR Pharmaceuticals Logo

COUR Pharmaceuticals

  • Our Company
    • Leadership
    • Advisors
    • Partners
    • Contact
  • Our Technology
    • Pipeline
    • Autoimmune Diseases
    • Allergies
    • Rare Diseases
    • Gene Therapy
  • Our Clinical Trials
  • Publications & Media
    • Press Releases
    • Publications
  • Careers

CNP-104 Clinical Trial Primary Biliary Cholangitis

Purpose

The main aim of this study is to see how safe and tolerable CNP-104, an investigational drug, is for people with primary biliary cholangitis and to determine if CNP-104 helps re-balance the immune system to reduce inflammation and restore healthy liver function in adults who do not respond to current treatments. All participants will receive CNP-104 or Placebo intravenously on Day 1 and Day 8. 

Key Requirements

Age
18-75 years old

Accepts healthy patients? No, participants must have primary biliary cholangitis.

Have an elevated alkaline phosphatase (ALP) blood test – this blood test measures the damage to your liver caused by primary biliary cholangitis.

Be unresponsive to ursodeoxycholic acid (UDCA) and/or obeticholicacid (OCA) after 6-months of treatment at a stable dose.

Active Clinical Sites

University of California Davis Health

Sacramento, CA

View On Map

Contact: Jerica Golez
Email: jagolez@ucdavis.edu
Phone: (1) 916-734-8696

Southern California Research Center

Coronado, CA

View On Map

Contact: Kasey Seyer
Email: kasey@researchscrc.com
Phone: (1) 619-552-0330

OM Research

Lancaster, CA

View On Map

Contact: Luisa Apurillo
Email: lapurillo@omclinicaltrials.com
Phone: (1) 661-388-2239

Peak Gastroenterology Associates Colorado Springs

Colorado Springs, CO

View On Map

Contact: Rutva Nakarani
Email:  rnakarani@peakgastro.com

GI PROS Research

Naples, FL

View On Map

Contact: Jori Williams
Email: jwilliamsresearch@aol.com
Phone: (1) 239-649-1336

Florida Research Institute

Lakewood Ranch, FL

View On Map

Contact: Myrlande Elichne
Email:  myrlande.elichne@fdhs.com

University Florida

Gainesville, FL

Contact: Lauren Morreli
Email:  Lauren.Morelli@medicine.ufl.edu

Massachusetts General Hospital

Boston, MA

View On Map

Contact: Raghav Bordia
Email:  RBORDIA@mgh.harvard.edu
Phone: (1) 617-643-7930

Henry Ford Health System

Novi, MI

View On Map

Contact: Sean Fazio
Email: Isfazio1@hfhs.org

Washington University School of Medicine in St. Louis

St. Louis, MO

View On Map

Contact: Jennifer Bruns
Email:  brunsi@wustl.edu
Phone: (1) 314-747-5366

Duke University Medical Center

Durham, NC

View On Map

Contact: Tina Lucas
Email: Tina.lucas@duke.edu
Phone: (1) 248-344-2356

Montefiore Medical Center

Bronx, NY

View On Map

Contact: Harith Raees
Email:  Hraees@montefiore.org

Texas Liver Institute

San Antonio, TX

View On Map

Contact: Jessica Courtright
Email: jcourtright@txliver.com
Phone: (1) 210-253-3426

University of Virginia

Charlottesville, VA

View On Map
Quote Block Decoration

How many participants are being enrolled?

The number of total participants to be enrolled in the clinical trial.

Approximately 40 participants.

Are placebos part of the clinical trial?

A placebo often looks like the investigational medication but has no active ingredient in it. It is used to compare against the actual investigational treatment to evaluate effectiveness.

Yes, participants will receive an infusion of either CNP-104 therapy or placebo.

How long is participation in the clinical trial?

The planned length of time each participant will take part in the clinical trial.

Participation in the study is approximately 2 years: there are 9 visits over the first 4 months and then quarterly visits for the next 20 months.

Clinicaltrials.gov

Clinical Trial Identifier

A Clinical Trial Identifier is a unique number assigned to a clinical trial by clinical trial registries around the world.

NCT05104853

Footer

COUR Pharmaceuticals Logo
  • Our Company
  • Our Technology
  • Our Partners
  • Press
  • Careers

©

2023

COUR Pharmaceuticals.
All Rights Reserved.

Privacy Policy • Terms of Use

Back to Top