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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
First received: August 2, 2013
Last updated: December 16, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Celiac Disease
Drug: ALV003
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Alvine Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Efficacy: Intestinal mucosal morphometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12

Secondary Outcome Measures:
  • Efficacy: Intestinal intraepithelial lymphocyte density [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)

  • Safety: safety and tolerability of ALV003 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Incidence of adverse events between baseline and week 12

Other Outcome Measures:
  • Celiac disease-specific serology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALV003 Drug: ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
Placebo Comparator: Placebo Drug: placebo


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917630

  Show 88 Study Locations
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Study Director: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
  More Information

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01917630     History of Changes
Other Study ID Numbers: ALV003-1221 
Study First Received: August 2, 2013
Last Updated: December 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac disease
Gluten-free diet
Coeliac disease
Celiac sprue

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on May 26, 2016