Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

July 30, 2012 updated by: Alvine Pharmaceuticals Inc.

A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

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

  • Finland
      • Kuopio, Finland
        • Terveystalo Kuopio
      • Oulu, Finland
        • Oulu Diakonissalaitos (ODL)
      • Tampere, Finland
        • FINN-MEDI Research Oy - Clinical Trials Center

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of biopsy-proven celiac disease
  • Adherence to a gluten-free diet
  • TG2 antibody negative
  • Signed informed consent

Exclusion Criteria:

  • Active dermatitis herpetiformis
  • History of IgE-mediated reactions to gluten
  • Use of specific medications 6 months prior to entry
  • History of alcohol abuse or illicit drug use
  • Current untreated or GI disease
  • Positive pregnancy test
  • Received any experimental drug within 14 days of randomization
  • Uncontrolled chronic disease or condition
  • Uncontrolled complications of celiac disease
  • Any medical condition which could adversely affect study participation

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
Experimental: ALV003
ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.
Biological: ALV003
Placebo Comparator: Placebo
Excipients for ALV003 absent the experimental compounds
Biological: ALV003 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Intestinal mucosal morphology
Time Frame: 6 weeks
Intestinal mucosal morphology - change from baseline to week 6
6 weeks
Safety: Tolerability of ALV003
Time Frame: 6 weeks
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Time Frame: 6 weeks
Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
6 weeks
Efficacy: Change in serological markers of celiac disease
Time Frame: 6 weeks
Serological markers of celiac disease - change from baseline to week 6
6 weeks

Collaborators and Investigators

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

Sponsor

Alvine Pharmaceuticals Inc.

Investigators

  • Principal Investigator: Marja-Leena Lähdeaho, MD, FINN-MEDI Research Oy
  • Study Chair: Markku Mäki, MD, PhD, Tampere University

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

November 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALV003-1021
  • 2010-023127-23 (EudraCT Number)

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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