Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

ImmusanT

Status and phase: Completed; Phase 1

Conditions: Gastrointestinal Disease; Intestinal Disease; Gluten Sensitivity; Coeliac Disease; Celiac Disease; Digestive System Diseases; Metabolic Disease; Malabsorption Syndromes

Treatments: Biological: Placebo; Biological: Nexvax2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03543540

Nexvax2-1005

Details and patient eligibility

About

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

Full description

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.

Enrollment: 14 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 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 4 patient groups, including a placebo group

Nexvax2 (Arm A)

Experimental group

Treatment:

Biological: Nexvax2

Nexvax2 (Arm B)

Experimental group

Treatment:

Biological: Nexvax2

Nexvax2 Placebo (Arm C)

Placebo Comparator group

Treatment:

Biological: Placebo

Nexvax2 Placebo (Arm D)

Placebo Comparator group

Treatment:

Biological: Placebo