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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03644069

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
ImmusanT, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Robert Anderson, PhD, FRACP
Principal Investigator Affiliation ImmusanT, Inc.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Australia, New Zealand, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Disease, Gluten Sensitivity, Autoimmune Diseases
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allegiance Research Specialists, Wauwatosa, Wisconsin

Status

Active, not recruiting

Address

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226

Site Contact

617-299-8399

Advanced Research Institute, South Ogden, Utah

Status

Active, not recruiting

Address

Advanced Research Institute

South Ogden, Utah, 84405

Site Contact

617-299-8399

Texas Digestive Disease Consultants, Southlake, Texas

Status

Active, not recruiting

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Site Contact

617-299-8399

Digestive Health Research, Hermitage, Tennessee

Status

Active, not recruiting

Address

Digestive Health Research

Hermitage, Tennessee, 37076

Site Contact

617-299-8399

Coastal Carolina Research, Mount Pleasant, South Carolina

Status

Active, not recruiting

Address

Coastal Carolina Research

Mount Pleasant, South Carolina, 29464

Site Contact

617-299-8399

Omega Medical Research, Warwick, Rhode Island

Status

Active, not recruiting

Address

Omega Medical Research

Warwick, Rhode Island, 02886

Site Contact

617-299-8399

Ocean State Clinical Research Partners, Lincoln, Rhode Island

Status

Active, not recruiting

Address

Ocean State Clinical Research Partners

Lincoln, Rhode Island, 02865

Site Contact

617-299-8399

Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Thomas Jefferson University Hospitals - Center City Campus

Philadelphia, Pennsylvania, 19107

Site Contact

617-299-8399

Great Lakes Gastroenterology Research, Mentor, Ohio

Status

Active, not recruiting

Address

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060

Site Contact

617-299-8399

PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina

Status

Active, not recruiting

Address

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103

Site Contact

617-299-8399

PMG Research of Piedmont Healthcare, Statesville, North Carolina

Status

Active, not recruiting

Address

PMG Research of Piedmont Healthcare

Statesville, North Carolina, 28625

Site Contact

617-299-8399

New York, New York

Status

Active, not recruiting

Address

Celiac Disease Center at Columbia University

New York, New York, 10032

Site Contact

617-299-8399

Drug Trials America, Hartsdale, New York

Status

Active, not recruiting

Address

Drug Trials America

Hartsdale, New York, 10530

Site Contact

617-299-8399

Great Neck, New York

Status

Active, not recruiting

Address

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023

Site Contact

617-299-8399

ActivMed Practices & Research, Portsmouth, New Hampshire

Status

Active, not recruiting

Address

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801

Site Contact

617-299-8399

AB Clinical Trials, Las Vegas, Nevada

Status

Active, not recruiting

Address

AB Clinical Trials

Las Vegas, Nevada, 89119

Site Contact

617-299-8399

Mayo Clinic, Rochester, Minnesota

Status

Active, not recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

617-299-8399

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Active, not recruiting

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

Site Contact

617-299-8399

Center for Digestive Health, Troy, Michigan

Status

Active, not recruiting

Address

Center for Digestive Health

Troy, Michigan, 48098

Site Contact

617-299-8399

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Active, not recruiting

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

Site Contact

617-299-8399

Heartland Research Associates, Wichita, Kansas

Status

Active, not recruiting

Address

Heartland Research Associates

Wichita, Kansas, 67207

Site Contact

617-299-8399

University of Iowa, Iowa City, Iowa

Status

Active, not recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

617-299-8399

PMG Research of McFarland Clinic, Ames, Iowa

Status

Active, not recruiting

Address

PMG Research of McFarland Clinic

Ames, Iowa, 50010

Site Contact

617-299-8399

Chicago, Illinois

Status

Active, not recruiting

Address

UCMC - Center for Clinical Cancer Genetics and Global Health

Chicago, Illinois, 60637

Site Contact

617-299-8399

Grand Teton Research Group, Idaho Falls, Idaho

Status

Active, not recruiting

Address

Grand Teton Research Group

Idaho Falls, Idaho, 83404

Site Contact

617-299-8399

Alliance Medical Research, Lighthouse Point, Florida

Status

Active, not recruiting

Address

Alliance Medical Research

Lighthouse Point, Florida, 33064

Site Contact

617-299-8399

Stamford Therapeutics Consortium, Stamford, Connecticut

Status

Active, not recruiting

Address

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905

Site Contact

617-299-8399

Diablo Clinical Research, Walnut Creek, California

Status

Active, not recruiting

Address

Diablo Clinical Research

Walnut Creek, California, 94598

Site Contact

617-299-8399

International Sites

P3 Research Limited, Mount Cook, New Zealand

Status

Active, not recruiting

Address

P3 Research Limited

Mount Cook, , 6021

Site Contact

617-299-8399

P3 Research Limited, Havelock North, New Zealand

Status

Active, not recruiting

Address

P3 Research Limited

Havelock North, ,

Site Contact

617-299-8399

Christchurch, New Zealand

Status

Active, not recruiting

Address

Gastroenterology and Endoscopy Specialists

Christchurch, , 8011

Site Contact

617-299-8399

Auckland Clinical Studies, Auckland, New Zealand

Status

Active, not recruiting

Address

Auckland Clinical Studies

Auckland, , 1010

Site Contact

617-299-8399

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Status

Active, not recruiting

Address

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009

Site Contact

617-299-8399

Parkville, Victoria, Australia

Status

Recruiting

Address

The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research

Parkville, Victoria, 3052

Site Contact

Cathy Pizzey

coeliac@wehi.edu.au

61 3 9345 2300

Alfred Hospital, Melbourne, Victoria, Australia

Status

Active, not recruiting

Address

Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

617-299-8399

Eastern Health-Box Hill Hospital, Box Hill, Victoria, Australia

Status

Active, not recruiting

Address

Eastern Health-Box Hill Hospital

Box Hill, Victoria, 3128

Site Contact

617-299-8399

Royal Adelaide Hospital, Adelaide, Southern Australia, Australia

Status

Active, not recruiting

Address

Royal Adelaide Hospital

Adelaide, Southern Australia, 5000

Site Contact

617-299-8399

Woolloongabba, Queensland, Australia

Status

Active, not recruiting

Address

The University of Queensland - Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

Site Contact

617-299-8399

Sippy Downs, Queensland, Australia

Status

Active, not recruiting

Address

Clinical Trials Centre - University of the Sunshine Coast

Sippy Downs, Queensland, 4556

Site Contact

617-299-8399

Coral Sea Clinical Research Institute, Mackay, Queensland, Australia

Status

Active, not recruiting

Address

Coral Sea Clinical Research Institute

Mackay, Queensland, 4740

Site Contact

617-299-8399

Auchenflower, Queensland, Australia

Status

Active, not recruiting

Address

The Wesley Hospital - The Wesley Research Institute

Auchenflower, Queensland, 4066

Site Contact

617-299-8399

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