Overview

This trial is active, not recruiting.

Condition celiac disease
Treatments alv003, placebo
Phase phase 2
Sponsor Alvine Pharmaceuticals Inc.
Start date August 2013
End date April 2015
Trial size 500 participants
Trial identifier NCT01917630, ALV003-1221

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
alv003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Efficacy: Intestinal mucosal morphometry
time frame: 12 weeks

Secondary Outcomes

Measure
Efficacy: Intestinal intraepithelial lymphocyte density
time frame: 12 weeks
Safety: safety and tolerability of ALV003
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Alvine Pharmaceuticals Inc..