Safety and Efficacy of Varying Methods of ALV003 Administration 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

NCT01255696

2010-023127-23 (EudraCT Number)

ALV003-1021

Details and patient eligibility

About

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

Enrollment: 61 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 study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

61 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

Placebo Comparator group

Description:

Excipients for ALV003 absent the experimental compounds

Treatment:

Biological: ALV003 placebo