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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Disease, Gluten Sensitivity, Autoimmune Diseases

In brief

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

Key facts

Study ID

NCT03644069

Run by

ImmusanT, Inc.

People needed

146

Starts

2018-08-06

Expected to finish

2019-09-01

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 70 years of age (inclusive)
• History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
• Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
• Willingness to consume a moderate amount of gluten
• Able to read and understand English
• Worsening of GI symptoms in response to an oral gluten challenge
• HLA DQ 2.5 positive

You may not qualify if…

• Unwilling or unable to perform self-injections
• History of inflammatory bowel disease and/or microscopic colitis.
• Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
• Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
• Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
• Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
• Females who are lactating or pregnant
• Receipt of any vaccine within 1 week prior to planned first day of the treatment period.

Where it is running

• Diablo Clinical Research — Walnut Creek, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Alliance Medical Research — Lighthouse PT, Florida, United States
• Grand Teton Research Group — Idaho Falls, Idaho, United States
• UCMC - Center for Clinical Cancer Genetics and Global Health — Chicago, Illinois, United States
• PMG Research of McFarland Clinic — Ames, Iowa, United States
• University of Iowa — Iowa City, Iowa, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• West Michigan Clinical Research Center — Wyoming, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• AB Clinical Trials — Las Vegas, Nevada, United States
• ActivMed Practices & Research — Portsmouth, New Hampshire, United States
• Long Island Gastrointestinal Research Group — Great Neck, New York, United States
• Drug Trials America — Hartsdale, New York, United States
• Celiac Disease Center at Columbia University — New York, New York, United States
• PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
• PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
• Great Lakes Gastroenterology Research — Mentor, Ohio, United States
• Thomas Jefferson University Hospitals - Center City Campus — Philadelphia, Pennsylvania, United States
• Ocean State Clinical Research Partners — Lincoln, Rhode Island, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Coastal Carolina Research — Mt. Pleasant, South Carolina, United States
• Digestive Health Research — Hermitage, Tennessee, United States

Full record on ClinicalTrials.gov

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