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A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 70 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, New Zealand, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Disease, Gluten Sensitivity, Autoimmune Diseases|
|Study Website:||View Trial Website|
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.
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