Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease
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
2 other identifiers
interventional
38
2 countries
4
Brief Summary
A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2017
CompletedDecember 24, 2018
April 1, 2017
1.4 years
August 17, 2015
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of toxicity and safety of Nexvax2 according to the "Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0"
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.
Treatment Period (~7 to 9 weeks)
Secondary Outcomes (2)
Weekly Gastrointestinal Symptom Rating Scale (GSRS)
Treatment Period (~7 to 9 weeks)
Plasma Cytokine Levels
Treatment Period (~7 to 9 weeks)
Study Arms (6)
Nexvax2 DQ2.5 Homozygotes (Cohort 1)
EXPERIMENTALNexvax2 by ID injections for a total of 14 doses over 46 days.
Nexvax2 Placebo DQ2.5 Homozygotes (Cohort 1)
PLACEBO COMPARATORNexvax2 Placebo by ID injections for a total of 14 doses over 46 days.
Nexvax2 DQ2.5 Non-homozygotes (Cohort 2)
EXPERIMENTALNexvax2 by ID injections for a total of 14 doses over 46 days.
Nexvax2 Placebo DQ2.5 Non-homozygotes (Cohort 2)
PLACEBO COMPARATORNexvax2 Placebo by ID injections for a total of 14 doses over 46 days.
Nexvax2 DQ2.5 Non-homozygotes (Cohort 3)
EXPERIMENTALNexvax2 by ID injections for 18 doses (up to 27 doses) over 60 days (maximum of 91 days).
Nexvax2 Placebo DQ2.5 Non-homozygotes (Cohort 3)
PLACEBO COMPARATORNexvax2 Placebo by ID injections for 18 doses (up to 27 doses) over 60 days (maximum of 91 days).
Interventions
Nexvax2 intra-dermal injections twice weekly
Sodium chloride 0.9% intra-dermal injections twice weekly
Eligibility Criteria
You may qualify if:
- Subject has signed and understands the informed consent form before initiation of any study specific procedures.
- Subject is between 18 and 70 years old (inclusive) on the date of the Screening Visit.
- 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.
- Subject has HLA DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02).
You may not qualify if:
- Subject has not been maintained on a gluten-free diet for at least 1 year.
- Celiac Dietary Adherence Test at screening indicates non-compliance to gluten-free diet (score \>12).
- 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.
- 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
- 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.
- 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.
- Subject is unable and/or unwilling to comply with study requirements.
- Subject has taken oral or parenteral corticosteroids within the previous six weeks prior to Screening. Topical or inhaled corticosteroids are acceptable.
- Subject has received an experimental therapy within 30 days prior to Screening.
- Subject has previously been enrolled and dosed in a clinical trial with Nevax2.
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ImmusanT, Inc.lead
Study Sites (4)
Q-Pharm Pty Ltd.
Herston, Queensland, 4006, Australia
CMAX, A Division of IDT Australia Ltd
Adelaide, South Australia, 5000, Australia
Linear Clinical Research
Nedlands, WA 6009, Australia
Auckland Clinical Studies Ltd
Auckland, 1150, New Zealand
Related Publications (1)
Daveson AJM, Ee HC, Andrews JM, King T, Goldstein KE, Dzuris JL, MacDougall JA, Williams LJ, Treohan A, Cooreman MP, Anderson RP. Epitope-Specific Immunotherapy Targeting CD4-Positive T Cells in Celiac Disease: Safety, Pharmacokinetics, and Effects on Intestinal Histology and Plasma Cytokines with Escalating Dose Regimens of Nexvax2 in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. EBioMedicine. 2017 Dec;26:78-90. doi: 10.1016/j.ebiom.2017.11.018. Epub 2017 Nov 22.
PMID: 29191561DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert P. Anderson, MB ChB, PhD
ImmusanT, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 19, 2015
Study Start
August 1, 2015
Primary Completion
January 6, 2017
Study Completion
January 6, 2017
Last Updated
December 24, 2018
Record last verified: 2017-04