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.

Diablo Clinical Research, Walnut Creek, California

Status

Recruiting

Address

Diablo Clinical Research

Walnut Creek, California, 94598

Site Contact

Lana Norman

lnorman@diabloclinical.com

925-930-7267

Stamford Therapeutics Consortium, Stamford, Connecticut

Status

Recruiting

Address

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905

Site Contact

Jeff Stein

jstein@stctrials.com

203-325-8529

Alliance Medical Research, Lighthouse Point, Florida

Status

Recruiting

Address

Alliance Medical Research

Lighthouse Point, Florida, 33064

Site Contact

Lizane Norelia

lizanenorelia@pioneerclinical.com

954-667-4226

Grand Teton Research Group, Idaho Falls, Idaho

Status

Recruiting

Address

Grand Teton Research Group

Idaho Falls, Idaho, 83404

Site Contact

Ana Goetsch

ana@gtrgi.org

208-528-4256

Chicago, Illinois

Status

Not yet recruiting

Address

UCMC - Center for Clinical Cancer Genetics and Global Health

Chicago, Illinois, 60637

Site Contact

617-299-8399

PMG Research of McFarland Clinic, Ames, Iowa

Status

Recruiting

Address

PMG Research of McFarland Clinic

Ames, Iowa, 50010

Site Contact

Erin Hackett

erin.hackett@pmg-research.com

515-956-4159

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Debi Heitshusen

debi-heitshusen@uiowa.edu

319-353-4576

Heartland Research Associates, Wichita, Kansas

Status

Recruiting

Address

Heartland Research Associates

Wichita, Kansas, 67207

Site Contact

Jill Hiebert

jhiebert@heartlandresearch.com

316-689-6683

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

Site Contact

Brittany McKenzie

bmckenzie@researchmi.com

586-598-3329

Center for Digestive Health, Troy, Michigan

Status

Recruiting

Address

Center for Digestive Health

Troy, Michigan, 48098

Site Contact

Heather LaHaise

hlahaise@troygastro.com

248-267-8485 #6606

West Michigan Clinical Research Center, Wyoming, Michigan

Status

Recruiting

Address

West Michigan Clinical Research Center

Wyoming, Michigan, 49519

Site Contact

Rochelle Copeland

rcopeland@gastro-assoc-wm.com

616-608-8730

Mayo Clinic, Rochester, Minnesota

Status

Not yet recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

617-299-8399

AB Clinical Trials, Las Vegas, Nevada

Status

Recruiting

Address

AB Clinical Trials

Las Vegas, Nevada, 89119

Site Contact

Atoya Adams, MD

dradams27@msn.com

702-804-5900

ActivMed Practices & Research, Portsmouth, New Hampshire

Status

Recruiting

Address

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801

Site Contact

Kendra Thibeault

kthibeault@activmedresearch.com

603-319-8863

Great Neck, New York

Status

Recruiting

Address

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023

Site Contact

Christine Raiser

christineraiser@ligiresearch.com

516-482-5976

Drug Trials America, Hartsdale, New York

Status

Recruiting

Address

Drug Trials America

Hartsdale, New York, 10530

Site Contact

Jeremy Tark

jtark@drugtrialsamerica.com

914-341-2346

New York, New York

Status

Not yet recruiting

Address

Celiac Disease Center at Columbia University

New York, New York, 10032

Site Contact

617-299-8399

PMG Research of Piedmont Healthcare, Statesville, North Carolina

Status

Recruiting

Address

PMG Research of Piedmont Healthcare

Statesville, North Carolina, 28625

Site Contact

Erin Hutchens

erin.hutchens@pmg-research.com

704-924-2105

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

Status

Recruiting

Address

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103

Site Contact

Ashley Schmidt

ashley.schmidt@pmg-research.com

336-768-8062

Great Lakes Gastroenterology Research, Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060

Site Contact

Michelle Scott

mscott@glmrx.com

440-205-1225 #209

Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospitals - Center City Campus

Philadelphia, Pennsylvania, 19107

Site Contact

Patrick Casey

patrick.casey@jefferson.edu

215-503-4683

Ocean State Clinical Research Partners, Lincoln, Rhode Island

Status

Recruiting

Address

Ocean State Clinical Research Partners

Lincoln, Rhode Island, 02865

Site Contact

David McPhail

dmcphailoscr@gmail.com

401-475-7007

Omega Medical Research, Warwick, Rhode Island

Status

Recruiting

Address

Omega Medical Research

Warwick, Rhode Island, 02886

Coastal Carolina Research, Mount Pleasant, South Carolina

Status

Recruiting

Address

Coastal Carolina Research

Mount Pleasant, South Carolina, 29464

Site Contact

Danielle Nelson

dnelson@coastalcarolinaresearch.com

843-856-3784

Digestive Health Research, Hermitage, Tennessee

Status

Recruiting

Address

Digestive Health Research

Hermitage, Tennessee, 37076

Texas Digestive Disease Consultants, Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Site Contact

Caela Watkins

cwatkins@tddctx.com

817-424-1525

Advanced Research Institute, South Ogden, Utah

Status

Recruiting

Address

Advanced Research Institute

South Ogden, Utah, 84405

Site Contact

Nephi Georgi

nephi@advresearch.org

801-409-2040

Allegiance Research Specialists, Wauwatosa, Wisconsin

Status

Recruiting

Address

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226

Site Contact

Melissa Voigt

voigt@arsmke.com

414-727-8131

International Sites

Auchenflower, Queensland, Australia

Status

Recruiting

Address

The Wesley Hospital - The Wesley Research Institute

Auchenflower, Queensland, 4066

Site Contact

Venita Bali

vbali@wesleyresearch.com.au

(07) 3721 1543

Coral Sea Clinical Research Institute, Mackay, Queensland, Australia

Status

Recruiting

Address

Coral Sea Clinical Research Institute

Mackay, Queensland, 4740

Site Contact

Amanda Flanagan

aflanaga@usc.edu.au

07 4942 3777

Sippy Downs, Queensland, Australia

Status

Recruiting

Address

Clinical Trials Centre - University of the Sunshine Coast

Sippy Downs, Queensland, 4556

Woolloongabba, Queensland, Australia

Status

Not yet recruiting

Address

The University of Queensland - Princess Alexandra Hospital

Woolloongabba, Queensland, 4102

Site Contact

Teressa Hansen

Teressa.Hansen@health.qld.gov.au

61418777202

Royal Adelaide Hospital, Adelaide, Southern Australia, Australia

Status

Not yet recruiting

Address

Royal Adelaide Hospital

Adelaide, Southern Australia, 5000

Site Contact

Lorelle Smith

Lorelle.smith@sa.gov.au

08 7074 2201

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

Status

Not yet recruiting

Address

Eastern Health-Box Hill Hospital

Box Hill, Victoria, 3128

Site Contact

Emma Dimitri

Emma.dimitri@monash.edu

+61 3 9094 9531

Alfred Hospital, Melbourne, Victoria, Australia

Status

Not yet recruiting

Address

Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Paula Lewis

Paula.Lewis@alfred.org.au

+61 3 90765276

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

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Status

Not yet recruiting

Address

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009

Site Contact

Jennifer Hu

jhu@linear.org.au

+61 8 6382 5123

Auckland Clinical Studies, Auckland, New Zealand

Status

Recruiting

Address

Auckland Clinical Studies

Auckland, , 1010

Christchurch, New Zealand

Status

Not yet recruiting

Address

Gastroenterology and Endoscopy Specialists

Christchurch, , 8011

Site Contact

617-299-8399

P3 Research Limited, Havelock North, New Zealand

Status

Recruiting

Address

P3 Research Limited

Havelock North, ,

Site Contact

Alison Strong

alison@p3research.co.nz

64 6 824 3071

P3 Research Limited, Mount Cook, New Zealand

Status

Recruiting

Address

P3 Research Limited

Mount Cook, , 6021

Site Contact

Mary McKay

mary@p3research.co.nz

64 4 801 0002

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.