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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01255696
First received: December 3, 2010
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  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 Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

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 ]
    Intestinal mucosal morphology - change from baseline to week 6

  • Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts


Secondary Outcome Measures:
  • Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6

  • Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Serological markers of celiac disease - change from baseline to week 6


Enrollment: 61
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (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
Placebo Comparator: Placebo
Excipients for ALV003 absent the experimental compounds
 Biological: ALV003 placebo

  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 study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255696

Locations
Finland
Terveystalo Kuopio
Kuopio, Finland
Oulu Diakonissalaitos (ODL)
Oulu, Finland
FINN-MEDI Research Oy - Clinical Trials Center
Tampere, Finland
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
Principal Investigator: Marja-Leena Lähdeaho, MD FINN-MEDI Research Oy
Study Chair: Markku Mäki, MD, PhD University of Tampere
  More Information

No publications provided

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01255696     History of Changes
Other Study ID Numbers: ALV003-1021, 2010-023127-23
Study First Received: December 3, 2010
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 Disease

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

ClinicalTrials.gov processed this record on May 19, 2013