Clinical trial NCT03543540: Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease
Official title: A Phase 1 Study of Nexvax2 Administered Subcutaneously After a Screening Gluten Food Challenge That Compares Relative Bioavailability With Intradermal Administration in Non-homozygous HLA-DQ2.5+ Adults With Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Celiac Disease
Intestinal Disease
Malabsorption Syndromes
Gastrointestinal Disease
Digestive System Diseases
Metabolic Disease
Coeliac Disease
Gluten Sensitivity
Lead sponsor: ImmusanT, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Safety of Nexvax 2 administered subcutaneously (SQ)
timeFrame: Treatment Period: 7 weeks
measure: Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
timeFrame: Treatment Period: 7 weeks
Secondary outcomes:
measure: Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
timeFrame: Treatment Period: 7 weeks
measure: Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
timeFrame: Treatment Period: 7 weeks
measure: Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
timeFrame: Treatment Period: 7 weeks
measure: Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
timeFrame: Treatment Period: 7 weeks
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Qpharm Pty Ltd
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: ImmusanT, Inc.
name: Robert Anderson, PhD, FRACP
role: STUDY_CHAIR
References: