Clinical trial NCT00959114: Safety and Efficacy of ALV003 for the Treatment of Celiac Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac Disease
Coeliac Disease
Celiac Sprue
Keliakia
Lead sponsor: Alvine Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Intestinal mucosal morphology
timeFrame: 6 weeks
measure: Safety: Tolerability of ALV003
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
timeFrame: 6 weeks
measure: Efficacy: Change in serological markers of celiac disease
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: FINN-MEDI Research - Clinical Trials Center
Study officials:
affiliation: FINN-MEDI Research
name: Marja-Leena Lähdeaho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University
name: Markku Mäki, Prof, MD, PhD
role: STUDY_CHAIR
References:
citation: Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.