NCT03543540

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: ImmusanT, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Nexvax2	Nexvax2 injections: 14 in total at twice weekly intervals
BIOLOGICAL	Placebo	Placebo injections: 14 in total at twice weekly intervals

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-09-10
• Completion: 2018-09-10
• First posted: 2018-06-01
• Last updated: 2018-09-20

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study