Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

• ClinicalTrials.gov Identifier: NCT03543540
• Recruitment Status: Completed
• First Posted: June 1, 2018
• Last Update Posted: September 20, 2018
• Sponsor: ImmusanT, Inc.
• Information provided by (Responsible Party): ImmusanT, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Celiac Disease; Intestinal Disease; Malabsorption Syndromes; Gastrointestinal Disease; Digestive System Diseases; Metabolic Disease; Coeliac Disease; Gluten Sensitivity	Biological: Nexvax2; Biological: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: September 10, 2018
• Actual Study Completion Date: September 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Australia, Queensland

Qpharm Pty Ltd

Herston, Queensland, Australia, 4006

University of the Sunshine Coast

Sippy Downs, Queensland, Australia, 4556

Australia, Western Australia

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009

Sponsors and Collaborators

ImmusanT, Inc.

Investigators

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

More Information

• Responsible Party: ImmusanT, Inc.
• ClinicalTrials.gov Identifier: NCT03543540
• Other Study ID Numbers: Nexvax2-1005
• First Posted: June 1, 2018
• Last Update Posted: September 20, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Celiac Disease; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases