Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-09-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nexvax2 (Arm A)

Group Type EXPERIMENTAL

Nexvax2

Intervention Type BIOLOGICAL

Nexvax2 injections: 14 in total at twice weekly intervals

Nexvax2 (Arm B)

Group Type EXPERIMENTAL

Nexvax2

Intervention Type BIOLOGICAL

Nexvax2 injections: 14 in total at twice weekly intervals

Nexvax2 Placebo (Arm C)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo injections: 14 in total at twice weekly intervals

Nexvax2 Placebo (Arm D)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo injections: 14 in total at twice weekly intervals

Interventions

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Nexvax2

Nexvax2 injections: 14 in total at twice weekly intervals

Intervention Type BIOLOGICAL

Placebo

Placebo injections: 14 in total at twice weekly intervals

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No