NCT01255696CompletedPhase 2
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
Alvine Pharmaceuticals Inc.3 sites in 1 country61 target enrollmentStarted: November 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alvine Pharmaceuticals Inc.
- Enrollment
- 61
- Locations
- 3
- Primary Endpoint
- Efficacy: Intestinal mucosal morphology
Study Overview
Brief Summary
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Placebo
Placebo Comparator
Excipients for ALV003 absent the experimental compounds
Intervention: ALV003 placebo (Biological)
ALV003
Experimental
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.
Intervention: ALV003 (Biological)
Outcomes
Primary Outcomes
Efficacy: Intestinal mucosal morphology
Time Frame: 6 weeks
Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003
Time Frame: 6 weeks
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts
Secondary Outcomes
- Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype(6 weeks)
- Efficacy: Change in serological markers of celiac disease(6 weeks)
Investigators
Study Sites (3)
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