Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease
Phase 2
Completed
- Conditions
- Celiac Disease
- Registration Number
- NCT01255696
- Lead Sponsor
- Alvine Pharmaceuticals Inc.
- Brief Summary
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy: Intestinal mucosal morphology 6 weeks Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003 6 weeks Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts
- Secondary Outcome Measures
Name Time Method Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype 6 weeks Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
Efficacy: Change in serological markers of celiac disease 6 weeks Serological markers of celiac disease - change from baseline to week 6
Trial Locations
- Locations (3)
Terveystalo Kuopio
🇫🇮Kuopio, Finland
Oulu Diakonissalaitos (ODL)
🇫🇮Oulu, Finland
FINN-MEDI Research Oy - Clinical Trials Center
🇫🇮Tampere, Finland
Terveystalo Kuopio🇫🇮Kuopio, Finland