- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959114
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease
July 30, 2012 updated by: Alvine Pharmaceuticals Inc.
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
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
74
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tampere, Finland
- FINN-MEDI Research - Clinical Trials Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
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Placebo Comparator: Placebo comparator
Excipients for ALV003 absent the experimental compounds
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ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: Intestinal mucosal morphology
Time Frame: 6 weeks
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6 weeks
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Safety: Tolerability of ALV003
Time Frame: 6 weeks
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Time Frame: 6 weeks
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6 weeks
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Efficacy: Change in serological markers of celiac disease
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marja-Leena Lähdeaho, MD, PhD, FINN-MEDI Research
- Study Chair: Markku Mäki, Prof, MD, PhD, Tampere University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
August 13, 2009
First Submitted That Met QC Criteria
August 13, 2009
First Posted (Estimate)
August 14, 2009
Study Record Updates
Last Update Posted (Estimate)
August 6, 2012
Last Update Submitted That Met QC Criteria
July 30, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALV003-0921
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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