Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

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

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

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases; Celiac Disease; Malabsorption Syndromes; Gastrointestinal Disease; Metabolic Disease; Gluten Sensitivity; Intestinal Disease; Coeliac Disease
• Intervention / Treatment: Biological: Nexvax2; Biological: Placebo

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • QPharm Pty Ltd
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nexvax2 (Arm A)	Biological: Nexvax2; Nexvax2 injections: 14 in total at twice weekly intervals
Experimental: Nexvax2 (Arm B)	Biological: Nexvax2; Nexvax2 injections: 14 in total at twice weekly intervals
Placebo Comparator: Nexvax2 Placebo (Arm C)	Biological: Placebo; Placebo injections: 14 in total at twice weekly intervals
Placebo Comparator: Nexvax2 Placebo (Arm D)	Biological: Placebo; Placebo injections: 14 in total at twice weekly intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Nexvax 2 administered subcutaneously (SQ)	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.	Treatment Period: 7 weeks
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration	Blood draws for plasma concentration	Treatment Period: 7 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ImmusanT, Inc.
• Investigators: Study Chair: Robert Anderson, PhD, FRACP, ImmusanT, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Celiac Disease; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Metabolic Diseases; Malabsorption Syndromes
• Other Study ID Numbers: Nexvax2-1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No