Safety and Efficacy of Varying Methods of ALV003 Administration 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 Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255696
• Other study ID #: ALV003-1021
• Secondary ID: 2010-023127-23
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: July 30, 2012
• Start date: November 2010
• Est. completion date: June 2011

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• 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 study 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 placebo

Locations

Country	Name	City	State
Finland	Terveystalo Kuopio	Kuopio
Finland	Oulu Diakonissalaitos (ODL)	Oulu
Finland	FINN-MEDI Research Oy - 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	Intestinal mucosal morphology - change from baseline to week 6	6 weeks	No
Primary	Safety: Tolerability of ALV003	Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts	6 weeks	Yes
Secondary	Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype	Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6	6 weeks	No
Secondary	Efficacy: Change in serological markers of celiac disease	Serological markers of celiac disease - change from baseline to week 6	6 weeks	No