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Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Primary Purpose

Celiac Disease, Intestinal Disease, Malabsorption Syndromes

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Nexvax2
Placebo
Sponsored by
ImmusanT, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qpharm Pty Ltd
  • University of the Sunshine Coast
  • Linear Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Nexvax2 (Arm A)

Nexvax2 (Arm B)

Nexvax2 Placebo (Arm C)

Nexvax2 Placebo (Arm D)

Arm Description

Outcomes

Primary Outcome Measures

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.
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
Blood draws for plasma concentration

Secondary Outcome Measures

Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Blood draw collected for cytokines
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
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Blood draw collected for PK

Full Information

First Posted
April 26, 2018
Last Updated
September 19, 2018
Sponsor
ImmusanT, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03543540
Brief Title
Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmusanT, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Intestinal Disease, Malabsorption Syndromes, Gastrointestinal Disease, Digestive System Diseases, Metabolic Disease, Coeliac Disease, Gluten Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nexvax2 (Arm A)
Arm Type
Experimental
Arm Title
Nexvax2 (Arm B)
Arm Type
Experimental
Arm Title
Nexvax2 Placebo (Arm C)
Arm Type
Placebo Comparator
Arm Title
Nexvax2 Placebo (Arm D)
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Nexvax2
Intervention Description
Nexvax2 injections: 14 in total at twice weekly intervals
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo injections: 14 in total at twice weekly intervals
Primary Outcome Measure Information:
Title
Safety of Nexvax 2 administered subcutaneously (SQ)
Description
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.
Time Frame
Treatment Period: 7 weeks
Title
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
Description
Blood draws for plasma concentration
Time Frame
Treatment Period: 7 weeks
Secondary Outcome Measure Information:
Title
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Description
Blood draw collected for cytokines
Time Frame
Treatment Period: 7 weeks
Title
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Description
Blood draw collected for Pharmacokinetic (PK) sample
Time Frame
Treatment Period: 7 weeks
Title
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Description
Blood draw collected for PK
Time Frame
Treatment Period: 7 weeks
Title
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Description
Blood draw collected for PK
Time Frame
Treatment Period: 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Anderson, PhD, FRACP
Organizational Affiliation
ImmusanT, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Qpharm Pty Ltd
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

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