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



Status:Active, not recruiting
Conditions:Infectious Disease, Endocrine, Gastrointestinal, Gastrointestinal, Nephrology, Digestive Disease
Therapuetic Areas:Endocrinology, Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:August 6, 2018
End Date:September 2019

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A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge

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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
We found this trial at
29
sites
Portsmouth, New Hampshire 03801
Principal Investigator: Roger Epstein
Phone: 603-319-8863
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: David Elliott
Phone: 319-353-4576
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
Principal Investigator: Eric Newton
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Principal Investigator: Thomas Klein
Phone: 316-689-6683
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1215 Duff Avenue
Ames, Iowa 50010
Principal Investigator: Bryan Feyen
Phone: 515-956-4159
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Auchenflower, Queensland
Principal Investigator: James Daveson
Phone: (07) 3721 1543
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Chesterfield, Michigan 48098
Principal Investigator: Ronald Fogel
Phone: 586-598-3329
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Chicago, Illinois 60637
Principal Investigator: Sonia Kupfer, MD
Phone: 773-834-7414
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Great Neck, New York 11023
Principal Investigator: Michael Goldstein
Phone: 516-482-5976
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Hartsdale, New York 10530
Principal Investigator: Michael Gerdis
Phone: 914-341-2346
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5653 Frist Boulevard
Hermitage, Tennessee 37076
Principal Investigator: George James
Phone: 615-499-4740
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Idaho Falls, Idaho 83404
Principal Investigator: Clint Behrend
Phone: 208-528-4256
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Las Vegas, Nevada 89119
Principal Investigator: Atoya Adams
Phone: 702-804-5900
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Lighthouse Point, Florida 33064
Principal Investigator: Vipin Gupta
Phone: 954-667-4226
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106 Nate Whipple Highway
Lincoln, Rhode Island 02865
Principal Investigator: Scott Wilson
Phone: 401-475-7007
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Mentor, Ohio 44060
Principal Investigator: Keith Friedenberg
Phone: 440-205-1225
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1156 Bowman Road
Mount Pleasant, South Carolina 29464
Principal Investigator: Cynthia Strout
Phone: 843-856-3784
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180 Fort Washington Avenue
New York, New York 10032
Principal Investigator: Benjamin Lebwohl, M.D.
Phone: 212-305-5422
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Philadelphia, Pennsylvania 19107
Principal Investigator: Anthony DiMarino
Phone: 215-503-4683
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Rochester, Minnesota 55905
Principal Investigator: Joseph Murray
Phone: 507-266-7842
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South Ogden, Utah 84405
Principal Investigator: John Lowe
Phone: 801-409-2040
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Southlake, Texas 76092
Principal Investigator: Timothy Ritter
Phone: 817-424-1525
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Stamford, Connecticut 06095
Principal Investigator: David Radin
Phone: 203-325-8529
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Statesville, North Carolina 28625
Principal Investigator: Vivek Trivedi
Phone: 704-924-2105
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Troy, Michigan 48098
Principal Investigator: John Weber
Phone: 248-267-8485
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Walnut creek, California 94598
Principal Investigator: Helen Stacey
Phone: 925-930-7267
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Wauwatosa, Wisconsin 53226
Principal Investigator: Samuel Idarraga
Phone: 414-727-8131
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
Principal Investigator: Robert Holmes
Phone: 336-768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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Wyoming, Michigan 49519
Principal Investigator: Allan Coates
Phone: 616-608-8730
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