Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543540
• Other study ID #: Nexvax2-1005
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: ImmusanT, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Nexvax2
Nexvax2 injections: 14 in total at twice weekly intervals
• Placebo
Placebo injections: 14 in total at twice weekly intervals

Locations

Country	Name	City	State
Australia	Qpharm Pty Ltd	Herston	Queensland
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	University of the Sunshine Coast	Sippy Downs	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
ImmusanT, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration	Blood draws for plasma concentration	Treatment Period: 7 weeks
Secondary	Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID	Blood draw collected for cytokines	Treatment Period: 7 weeks
Secondary	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
Secondary	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
Secondary	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

External Links

•   ImmusanT