A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Nexvax2 intra-dermal injections twice weekly
Sodium chloride 0.9% intra-dermal injections twice weekly
Q-Pharm Pty Ltd.
Herston, Queensland, Australia
CMAX, A Division of IDT Australia Ltd
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Australia
Auckland Clinical Studies Ltd
Auckland, New Zealand
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.
Time frame: Treatment Period (~7 to 9 weeks)
Weekly Gastrointestinal Symptom Rating Scale (GSRS)
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.
Time frame: Treatment Period (~7 to 9 weeks)
Plasma Cytokine Levels
The relative change from pre-dose levels up to 10 hours after dosing in the concentration of plasma cytokines.
Time frame: Treatment Period (~7 to 9 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.