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Trial record 1 of 1 for:    Nexvax2-1004
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Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02528799
First Posted: August 19, 2015
Last Update Posted: April 21, 2017
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.
Information provided by (Responsible Party):
ImmusanT, Inc.
  Purpose
A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.

Condition Intervention Phase
Celiac Disease Biological: Nexvax2 Biological: Nexvax2 placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Nexvax2 Preceded by a Dose Titration Period in Subjects With Celiac Disease Currently on a Gluten-Free Diet

Resource links provided by NLM:


Further study details as provided by ImmusanT, Inc.:

Primary Outcome Measures:
  • Incidence of toxicity and safety of Nexvax2 according to the "Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0" [ Time Frame: Treatment Period (~7 to 9 weeks) ]
    Number and Percentage of Participants with Treatment-related Adverse Events assessed by the "Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 will be tabulated using counts and proportions detailing frequently occurring, serious and severe events. Adverse events will be summarized using all adverse events experienced, although a sub-analysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to study treatments.


Secondary Outcome Measures:
  • Weekly Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Treatment Period (~7 to 9 weeks) ]
    The GSRS score is the average weekly scores for 15 symptoms rated on a 7-point severity scale. GSRS scores over the 6-week Treatment Period will be compared.

  • Plasma Cytokine Levels [ Time Frame: Treatment Period (~7 to 9 weeks) ]
    The relative change from pre-dose levels up to 10 hours after dosing in the concentration of plasma cytokines.


Enrollment: 38
Study Start Date: August 2015
Study Completion Date: January 6, 2017
Primary Completion Date: January 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexvax2 DQ2.5 Homozygotes (Cohort 1)
Nexvax2 by ID injections for a total of 14 doses over 46 days.
Biological: Nexvax2
Nexvax2 intra-dermal injections twice weekly
Placebo Comparator: Nexvax2 Placebo DQ2.5 Homozygotes (Cohort 1)
Nexvax2 Placebo by ID injections for a total of 14 doses over 46 days.
Biological: Nexvax2 placebo
Sodium chloride 0.9% intra-dermal injections twice weekly
Experimental: Nexvax2 DQ2.5 Non-homozygotes (Cohort 2)
Nexvax2 by ID injections for a total of 14 doses over 46 days.
Biological: Nexvax2
Nexvax2 intra-dermal injections twice weekly
Placebo Comparator: Nexvax2 Placebo DQ2.5 Non-homozygotes (Cohort 2)
Nexvax2 Placebo by ID injections for a total of 14 doses over 46 days.
Biological: Nexvax2 placebo
Sodium chloride 0.9% intra-dermal injections twice weekly
Experimental: Nexvax2 DQ2.5 Non-homozygotes (Cohort 3)
Nexvax2 by ID injections for 18 doses (up to 27 doses) over 60 days (maximum of 91 days).
Biological: Nexvax2
Nexvax2 intra-dermal injections twice weekly
Placebo Comparator: Nexvax2 Placebo DQ2.5 Non-homozygotes (Cohort 3)
Nexvax2 Placebo by ID injections for 18 doses (up to 27 doses) over 60 days (maximum of 91 days).
Biological: Nexvax2 placebo
Sodium chloride 0.9% intra-dermal injections twice weekly

Detailed Description:
This is a randomized, double-blind, placebo-controlled, study to evaluate the safety and tolerability of Nexvax2 preceded by dose titration period in patients with celiac disease currently on a gluten-free diet. The study will consist of a Screening Period, a Treatment Period, and a Follow-up Period. Eligible subjects will be enrolled in one of three cohorts according to whether they are homozygous or not homozygous for both genes coding for HLA-DQ2.5.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subject has signed and understands the informed consent form before initiation of any study specific procedures.
  2. Subject is between 18 and 70 years old (inclusive) on the date of the Screening Visit.
  3. Subject has been diagnosed with celiac disease on the basis of intestinal histology showing villous atrophy according to expert guidelines current at the time of diagnosis.
  4. Subject has HLA DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02).

Exclusion Criteria:

  1. Subject has not been maintained on a gluten-free diet for at least 1 year.
  2. Celiac Dietary Adherence Test at screening indicates non-compliance to gluten-free diet (score >12).
  3. Serum levels of both recombinant human transglutaminase (tTG)-specific immunoglobulin-A (IgA) and deamidated gliadin peptide (DGP)-specific immunoglobulin-G (IgG) are elevated above the manufacturer's upper limit of normal. The elevation of one or other of the serology test for tTG IgA and DGP IgG is not an exclusion.
  4. Subject has uncontrolled complications of celiac disease or a medical condition which, in the opinion of the investigator, would impact the immune response or pose an increased risk to the subject.
  5. Subject is or has been using an immuno-modulatory or immune suppressing medical treatment during the 2 months prior to Screening, for example azathioprine, methotrexate, or biological
  6. Subject is female and premenopausal or perimenopausal and has a male partner who is not sterile, unless she is sterile, or she practices true abstinence, or unless throughout the entire study period and for 30 days after study drug discontinuation she is using a medically acceptable method of contraception.
  7. Subject is male with a premenopausal or perimenopausal female partner who is not sterile, unless he is sterile, or he practices true abstinence, or unless throughout the entire study period and for 30 days after study drug discontinuation he is using a medically acceptable method of contraception, or unless his female partner is using a medically acceptable method of contraception.
  8. Subject is unable and/or unwilling to comply with study requirements.
  9. Subject has taken oral or parenteral corticosteroids within the previous six weeks prior to Screening. Topical or inhaled corticosteroids are acceptable.
  10. Subject has received an experimental therapy within 30 days prior to Screening.
  11. Subject has previously been enrolled and dosed in a clinical trial with Nevax2.
  12. Subject has any of the following laboratory abnormalities at Screening:

    • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) ≥ 2 × the upper limit of normal (ULN)
    • Hemoglobin <10 g/dL
    • Platelet count <100 × 109/L
    • White blood cell count (WBC) outside the normal range and judged clinically significant by the investigator
    • Direct bilirubin outside the normal range
    • Any other clinically significant abnormal laboratory values, as determined by the investigator
  13. Subject is lactating, is known to be pregnant, has a positive pregnancy test at Screening or Treatment Day, intends to become pregnant, or is nursing.
  14. Subject has a history or presence of any medically significant condition considered by the investigator to have the potential to adversely affect participation in the study and/or interpretation of the study results.
  15. Subject has a history of severe allergic reactions (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that require medical intervention.
  16. Subject has donated blood ≤ 56 days prior to Screening and plans to donate blood within 5 weeks after study completion.
  17. Subject has a clinically relevant abnormality on electrocardiogram (ECG), as determined by the investigator.
  18. Other unspecified reasons that in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.
  Contacts and Locations
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): NCT02528799


Locations
Australia, Queensland
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006
Australia, South Australia
CMAX, A Division of IDT Australia Ltd
Adelaide, South Australia, Australia, 5000
Australia
Linear Clinical Research
Nedlands, Australia, WA 6009
New Zealand
Auckland Clinical Studies Ltd
Auckland, New Zealand, 1150
Sponsors and Collaborators
ImmusanT, Inc.
Investigators
Study Chair: Robert P. Anderson, MB ChB, PhD ImmusanT, Inc.
  More Information

Additional Information:
Responsible Party: ImmusanT, Inc.
ClinicalTrials.gov Identifier: NCT02528799     History of Changes
Other Study ID Numbers: Nexvax2-1004
U1111-1173-7522 ( Other Identifier: New Zealand Universal Trial Number (UTN) )
First Submitted: August 17, 2015
First Posted: August 19, 2015
Last Update Posted: April 21, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases