Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959114
• Other study ID #: ALV003-0921
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2009
• Last updated: July 30, 2012
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: July 2012
• Source: Alvine Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 participation

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

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

Locations

Country	Name	City	State
Finland	FINN-MEDI Research - Clinical Trials Center	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Alvine Pharmaceuticals Inc.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Intestinal mucosal morphology		6 weeks	No
Primary	Safety: Tolerability of ALV003		6 weeks	Yes
Secondary	Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype		6 weeks	No
Secondary	Efficacy: Change in serological markers of celiac disease		6 weeks	No