Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Phase 1

Completed

• Conditions: Gastrointestinal Disease; Digestive System Diseases; Celiac Disease; Intestinal Disease; Gluten Sensitivity; Coeliac Disease; Malabsorption Syndromes; Metabolic Disease
• Interventions: Biological: Nexvax2; Biological: Placebo

• Registration Number: NCT03543540
• Lead Sponsor: ImmusanT, Inc.

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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study Start: 2018-05-01
• Study First Submitted QC: 2018-05-19
• Study First Posted: 2018-06-01
• Status Verified: 2018-09
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexvax2 (Arm A)	Nexvax2	-
Nexvax2 (Arm B)	Nexvax2	-
Nexvax2 Placebo (Arm C)	Placebo	-
Nexvax2 Placebo (Arm D)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration	Treatment Period: 7 weeks	Blood draws for plasma concentration
Safety of Nexvax 2 administered subcutaneously (SQ)	Treatment Period: 7 weeks	Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.

Secondary Outcome Measures

Name	Time	Method
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.	Treatment Period: 7 weeks	Blood draw collected for Pharmacokinetic (PK) sample
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.	Treatment Period: 7 weeks	Blood draw collected for PK
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID	Treatment Period: 7 weeks	Blood draw collected for cytokines
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.	Treatment Period: 7 weeks	Blood draw collected for PK

Trial Locations

Locations (3)

University of the Sunshine Coast; 🇦🇺 Sippy Downs, Queensland, Australia

Qpharm Pty Ltd; 🇦🇺 Herston, Queensland, Australia

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia