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

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

Southern California Research Center

Coronado, CA

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

OM Research

Lancaster, CA

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

Peak Gastroenterology Associates Colorado Springs

Colorado Springs, CO

Contact: Rutva Nakarani
Email: rnakarani@peakgastro.com

GI PROS Research

Naples, FL

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

Florida Research Institute

Lakewood Ranch, FL

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

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

Henry Ford Health System

Novi, MI

Contact: Sean Fazio
Email: Isfazio1@hfhs.org

Washington University School of Medicine in St. Louis

St. Louis, MO

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

Duke University Medical Center

Durham, NC

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

Montefiore Medical Center

Bronx, NY

Contact: Harith Raees
Email: Hraees@montefiore.org

Texas Liver Institute

San Antonio, TX

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

University of Virginia

Charlottesville, VA

Approximately 40 participants.

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

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.