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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255696
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : August 6, 2012
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 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 Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease
Study Start Date : November 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

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
Placebo Comparator: Placebo
Excipients for ALV003 absent the experimental compounds
Biological: ALV003 placebo

Primary Outcome Measures :
  1. Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
    Intestinal mucosal morphology - change from baseline to week 6

  2. Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]
    Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Secondary Outcome Measures :
  1. Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ]
    Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6

  2. Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ]
    Serological markers of celiac disease - change from baseline to week 6

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT01255696

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Terveystalo Kuopio
Kuopio, Finland
Oulu Diakonissalaitos (ODL)
Oulu, Finland
FINN-MEDI Research Oy - Clinical Trials Center
Tampere, Finland
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
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Principal Investigator: Marja-Leena Lähdeaho, MD FINN-MEDI Research Oy
Study Chair: Markku Mäki, MD, PhD Tampere University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alvine Pharmaceuticals Inc. Identifier: NCT01255696    
Other Study ID Numbers: ALV003-1021
2010-023127-23 ( EudraCT Number )
First Posted: December 7, 2010    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 Disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases