Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

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 on one occasion during screening.
  • - Able to read and understand English.

Exclusion Criteria:

  • - 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

Trial ID:

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.

NCT03543540
Phase

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 1
Lead Sponsor

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

ImmusanT, Inc.
Principal Investigator

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

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

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

Industry
Overall Status Recruiting
Countries Australia
Conditions

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

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

A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who, have been following a gluten free diet for at least 12 consecutive months prior to screening. The study will evaluate the safety and tolerability of Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. The study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit.

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.

International Sites

Qpharm Pty Ltd, Herston, Queensland, Australia

Status

Recruiting

Address

Qpharm Pty Ltd

Herston, Queensland, 4006

Site Contact

Maggie Fung

m.fung@qpharm.com.au

+61 7 3845 3629

University of the Sunshine Coast, Sippy Downs, Queensland, Australia

Status

Recruiting

Address

University of the Sunshine Coast

Sippy Downs, Queensland, 4556

Site Contact

Georgina Street

gstreet@usc.edu.au

+61 7 5456 3797

Linear Clinical Research, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Linear Clinical Research

Nedlands, Western Australia, 6009

Site Contact

Shashi Aggarwal

saggarwal@linear.org.au

+61 432 605 618

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