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
  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:


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
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: 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 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: 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 September 18, 2014