Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease

August 24, 2023 updated by: ChemoCentryx

Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn's Disease

The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on the some of the symptoms of Crohn's Disease in patients who are experiencing an active flare-up of moderate to severe Crohn's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CCX282-B is being developed as a treatment for inflammatory bowel diseases such as Crohn's Disease. CCX282-B is a highly potent, orally active, chemokine receptor antagonist whose single target is the G-protein coupled receptor CCR9. The CCR9 receptor is expressed by most T-cells in the thymus as well as in the intestine, and by a small population of T-cells in the peripheral blood. In humans, the CCR9 receptor is implicated in Crohn's Disease and ulcerative colitis.

Crohn's Disease is an autoimmune disease involving the entire length of the gastrointestinal tract, but with most manifestations in the terminal small intestine and colon. This condition is characterized by mucosal ulcerations that penetrate deeply into the bowel wall. Sometimes the ulcerative lesions completely penetrate the bowel wall, leading to fistula formation and infectious complications requiring surgical intervention. Patients experience considerable lifestyle disruption and disability from this disease, including diarrhea, abdominal pain, malnutrition, anemia, and repetitive surgeries to remove disease-affected gastrointestinal segments.

ChemoCentryx Protocol CL003_282 is a double-blind, placebo-controlled, parallel group, two stratum, Phase 2A pilot study of the safety, tolerability, immunologic and clinical activity, and population pharmacokinetics of a single dose level of CCX282-B administered daily for four consecutive weeks to patients with active, moderate to severe Crohn's Disease. The primary immunologic and clinical activity objective of this study is to provide pilot information regarding the immunologic and clinical activity of daily oral doses of CCX282-B in the treatment of moderate to severe Crohn's Disease, based on changes in the Crohn's Disease Activity Index (CDAI). Secondary immunologic and clinical activity objectives include evaluation of the effect of CCX282-B on the Inflammatory Bowel Disease Questionnaire (IBDQ) instrument, C-reactive protein (CRP), the endoscopic appearance and biopsy of the colon and terminal ileum, and markers of leukocyte subsets and activation status. The primary safety objective of this study is to evaluate the safety and tolerability of oral doses of CCX282-B in patients with moderate to severe Crohn's Disease. In addition, blood samples will be collected for evaluation of the population pharmacokinetics of CCX282-B.

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Colorado
      • Golden, Colorado, United States, 80104
        • Rocky Mountain Clincal Research
      • Littleton, Colorado, United States, 80120
        • Arapahoe Gastroenterology
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic Rochester
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Forest Research
    • Ohio
      • Cleveland, Ohio, United States, 44106-5066
        • University Hospitals of Cleveland, Div of Gastroenterology
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Digestive Disease Clinic
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Center for Colon Rectal Disease
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System, Digestive Health Center of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be active at the time of study entry
  • Use of adequate and approved methods of birth control throughout the study period
  • Willing and able to sign an informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; the virus that causes AIDS)
  • Abuse of alcohol or of illegal drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Crohn's Disease Activity Index score
Safety (Adverse Events, tolerability)

Secondary Outcome Measures

Outcome Measure
C-reactive protein
Inflammatory Bowel Disease Questionnaire
Endoscopic appearance and biopsy of colon and terminal ileum
Markers of leukocyte subsets and activation status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ChemoCentryx

Investigators

  • Study Director: MD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 4, 2005

First Submitted That Met QC Criteria

February 4, 2005

First Posted (Estimated)

February 7, 2005

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL003_282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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