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

ImmusanT

Status and phase

Unknown

Phase 2

Conditions

Gastrointestinal Disease

Intestinal Disease

Gluten Sensitivity

Celiac Disease

Celiac

Malabsorption Syndromes

Digestive System Disease

Autoimmune Diseases

Treatments

Biological: Nexvax2

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03644069

Nexvax2-2006

Details and patient eligibility

About

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

Full description

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.

Enrollment

146 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.