Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

Alvine Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Biological: ALV003 placebo; Biological: ALV003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959114

ALV003-0921

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

ALV003

Experimental group

Description:

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.

Treatment:

Biological: ALV003

Placebo comparator

Placebo Comparator group

Description:

Excipients for ALV003 absent the experimental compounds

Treatment:

Biological: ALV003 placebo