Last updated on December 2018

A Study of the Safety Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)


Brief description of study

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

Detailed Study Description

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.

Clinical Study Identifier: NCT03644069

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Ronald Fogel

Clinical Research Institute of Michigan
Chesterfield, MI United States
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John Weber

Center for Digestive Health
Troy, MI United States
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Atoya Adams

AB Clinical Trials
Las Vegas, NV United States
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Michael Goldstein

Long Island Gastrointestinal Research Group
Great Neck, NY United States
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Michael Gerdis

Drug Trials America
Hartsdale, NY United States
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Robert Holmes

PMG Research of Winston-Salem, LLC
Winston-Salem, NC United States
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Scott Wilson

Ocean State Clinical Research Partners
Lincoln, RI United States
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Helen Stacey

Diablo Clinical Research
Walnut Creek, CA United States
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David Radin

Stamford Therapeutics Consortium
Stamford, CT United States
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Vipin Gupta

Alliance Medical Research
Lighthouse Point, FL United States
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Clint Behrend

Grand Teton Research Group
Idaho Falls, ID United States
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Kristin Neff

UCMC - Center for Clinical Cancer Genetics and Global Health
Chicago, IL United States
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Bryan Feyen

PMG Research of McFarland Clinic
Ames, IA United States
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David Elliott

University of Iowa
Iowa City, IA United States
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Thomas Klein

Heartland Research Associates
Wichita, KS United States
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Allan Coates

West Michigan Clinical Research Center
Wyoming, MI United States
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Kristin Neff

Mayo Clinic
Rochester, MN United States
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Roger Epstein

ActivMed Practices & Research
Portsmouth, NH United States
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Kristin Neff

Celiac Disease Center at Columbia University
New York, NY United States
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Vivek Trivedi

PMG Research of Piedmont Healthcare
Statesville, NC United States
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Keith Friedenberg

Great Lakes Gastroenterology Research
Mentor, OH United States
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Anthony DiMarino

Thomas Jefferson University Hospitals - Center City Campus
Philadelphia, PA United States
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Eric Newton

Omega Medical Research
Warwick, RI United States
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Cynthia Strout

Coastal Carolina Research
Mount Pleasant, SC United States
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George James

Digestive Health Research
Hermitage, TN United States
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Timothy Ritter

Texas Digestive Disease Consultants
Southlake, TX United States
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John Lowe

Advanced Research Institute
South Ogden, UT United States
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Samuel Idarraga

Allegiance Research Specialists
Wauwatosa, WI United States
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James Daveson

The Wesley Hospital - The Wesley Research Institute
Auchenflower, Australia
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James Daveson

Coral Sea Clinical Research Institute
Mackay, Australia
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Susan Thackwray

Clinical Trials Centre - University of the Sunshine Coast
Sippy Downs, Australia
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Gerald Holtmann

The University of Queensland - Princess Alexandra Hospital
Woolloongabba, Australia
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Jane Andrews

Royal Adelaide Hospital
Adelaide, Australia
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SweeLin Chen Yi Mei

Eastern Health-Box Hill Hospital
Box Hill, Australia
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Gregor Brown

Alfred Hospital
Melbourne, Australia
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Jason Tye-Din

The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research
Parkville, Australia
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Hooi Ee

Sir Charles Gairdner Hospital
Nedlands, Australia
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Timothy King

Auckland Clinical Studies
Auckland, New Zealand
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Kristin Neff

Gastroenterology and Endoscopy Specialists
Christchurch, New Zealand
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Dean Quinn

P3 Research Limited
Mount Cook, New Zealand
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Alison Strong

P3 Research Limited
Havelock North, New Zealand
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Recruitment Status: Open


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