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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01917630
• Other study ID #: ALV003-1221
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 2, 2013
• Last updated: December 16, 2014
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: Alvine Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alvine Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Ireland,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Celiac disease-specific serology		12 weeks	No
Other	Quality of life		12 weeks	No
Primary	Efficacy: Intestinal mucosal morphometry	Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12	12 weeks	No
Secondary	Efficacy: Intestinal intraepithelial lymphocyte density	Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)	12 weeks	No
Secondary	Safety: safety and tolerability of ALV003	Incidence of adverse events between baseline and week 12	12 weeks	Yes