Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00959114
First received: August 13, 2009
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Celiac Disease
Biological: ALV003
Biological: ALV003 placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alvine Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
Placebo Comparator: Placebo comparator
Excipients for ALV003 absent the experimental compounds
Biological: ALV003 placebo
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959114

Locations
Finland
FINN-MEDI Research - Clinical Trials Center
Tampere, Finland
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
Principal Investigator: Marja-Leena Lähdeaho, MD, PhD FINN-MEDI Research
Study Chair: Markku Mäki, Prof, MD, PhD University of Tampere
  More Information

No publications provided by Alvine Pharmaceuticals Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00959114     History of Changes
Other Study ID Numbers: ALV003-0921
Study First Received: August 13, 2009
Last Updated: July 30, 2012
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency

Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac Disease
Coeliac Disease
Celiac Sprue
Keliakia

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014