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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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.

Key facts

Study ID

NCT01917630

Run by

Alvine Pharmaceuticals Inc.

People needed

500

Starts

2013-08-01

Expected to finish

2015-06-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Kansas City, Missouri, United States
• Study site — Mexico, Missouri, United States
• Study site — Marlton, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Rochester, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Mentor, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Malvern, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Hermitage, Tennessee, United States
• Study site — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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