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Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

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ClinicalTrials.gov Identifier: NCT00959114
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Celiac Disease Biological: ALV003 Biological: ALV003 placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
  2. Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ]
  2. Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: July 2012

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

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