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Trial record 1 of 1 for:    nexvax2-1005
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Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543540
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
ImmusanT, Inc.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543540


Locations
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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
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Study Chair: Robert Anderson, PhD, FRACP ImmusanT, Inc.
Additional Information:
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Responsible Party: ImmusanT, Inc.
ClinicalTrials.gov Identifier: NCT03543540    
Other Study ID Numbers: Nexvax2-1005
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Metabolic Diseases