Celiac Disease
Conditions
Keywords
Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia
Brief summary
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
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.
Interventions
BIOLOGICALALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
BIOLOGICALALV003 placebo
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
Sponsors
Alvine Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Intestinal mucosal morphology | 6 weeks |
| Safety: Tolerability of ALV003 | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype | 6 weeks |
| Efficacy: Change in serological markers of celiac disease | 6 weeks |
Countries
Finland
Outcome results
None listed