Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

December 16, 2014 updated by: Alvine Pharmaceuticals Inc.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
      • Ottawa, Ontario, Canada, K2H 7B3
      • Toronto, Ontario, Canada, M9C 4Z5
  • Finland
      • Tampere, Finland
  • Ireland
      • Galway, Ireland
  • Norway
      • Oslo, Norway
  • United Kingdom
      • Sheffield, United Kingdom, S11 7FF
  • United States
    • Alabama
      • Decatur, Alabama, United States, 35601
      • Huntsville, Alabama, United States, 35801
      • Huntsville, Alabama, United States, 35802
    • Arizona
      • Scottsdale, Arizona, United States, 85259
      • Scottsdale, Arizona, United States, 85260
      • Tucson, Arizona, United States, 85712
    • California
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90025
      • Modesto, California, United States, 95355
      • Newport Beach, California, United States, 92660
      • Oceanside, California, United States, 92056
      • Orange, California, United States, 92868
      • Palo Alto, California, United States, 94301
      • Poway, California, United States, 92064
      • Roseville, California, United States, 95661
      • San Diego, California, United States, 92114
      • San Jose, California, United States, 95117
      • San Marcos, California, United States, 92069
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32224
      • Largo, Florida, United States, 33777
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33165
      • Naples, Florida, United States, 34102
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30328
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
      • Evanston, Illinois, United States, 60201
      • Oak Lawn, Illinois, United States, 60453
    • Iowa
      • Des Moines, Iowa, United States, 50266
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Maryland
      • Baltimore, Maryland, United States, 21229
      • Chevy Chase, Maryland, United States, 20815
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Chesterfield, Michigan, United States, 48047
      • Wyoming, Michigan, United States, 49519
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Kansas City, Missouri, United States, 64131
      • Mexico, Missouri, United States, 65265
    • New Jersey
      • Marlton, New Jersey, United States, 08053
    • New York
      • Great Neck, New York, United States, 11023
      • New York, New York, United States, 10032
      • Poughkeepsie, New York, United States, 12601
      • Rochester, New York, United States, 14618
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Salisbury, North Carolina, United States, 28144
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44122
      • Dayton, Ohio, United States, 45415
      • Mentor, Ohio, United States, 44060
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15243
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
      • Hermitage, Tennessee, United States, 37076
    • Texas
      • Houston, Texas, United States, 77094
      • Irving, Texas, United States, 75063
      • Southlake, Texas, United States, 76092
    • Utah
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Virginia Beach, Virginia, United States, 23454
    • Washington
      • Bellevue, Washington, United States, 98004
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
      • Milwaukee, Wisconsin, United States, 53215

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 to 80 years
  • Physician diagnosed celiac disease
  • Adherence to a gluten-free diet
  • Experiencing symptoms of celiac disease over a 1-month period
  • Willing to take study medication for 12 weeks
  • Willing to comply with all study procedures
  • Sign informed consent

Exclusion Criteria:

  • Active inflammatory bowel disease
  • Active dermatitis herpetiformis
  • Use of certain specific medications prior to entry
  • History of alcohol or illicit drug abuse in previous 6 months
  • Pregnant or lactating
  • Received any experimental drug within 30 days of enrollment
  • Uncontrolled chronic disease or condition

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Experimental: ALV003
Drug: ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Intestinal mucosal morphometry
Time Frame: 12 weeks
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Intestinal intraepithelial lymphocyte density
Time Frame: 12 weeks
Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
12 weeks
Safety: safety and tolerability of ALV003
Time Frame: 12 weeks
Incidence of adverse events between baseline and week 12
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 12 weeks
12 weeks
Celiac disease-specific serology
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Alvine Pharmaceuticals Inc.

Investigators

  • Study Director: Daniel Adelman, MD, Alvine Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALV003-1221

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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