Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

Alvine Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Celiac Disease

Treatments: Drug: ALV003; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917630

ALV003-1221

Details and patient eligibility

About

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18 to 80 years
• Physician diagnosed celiac disease
• Adherence to a gluten-free diet
• Experiencing symptoms of celiac disease over a 1-month period
• Willing to take study medication for 12 weeks
• Willing to comply with all study procedures
• Sign informed consent

Exclusion criteria

• Active inflammatory bowel disease
• Active dermatitis herpetiformis
• Use of certain specific medications prior to entry
• History of alcohol or illicit drug abuse in previous 6 months
• Pregnant or lactating
• Received any experimental drug within 30 days of enrollment
• Uncontrolled chronic disease or condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

ALV003

Experimental group

Treatment:

Drug: ALV003

Placebo

Placebo Comparator group

Treatment:

Drug: placebo