Safety Study of Nexvax2 in Subjects With Coeliac Disease

Study Overview
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Brief Summary
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The main purpose of this study is to determine the safety of weekly injections of Nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet. The second purpose of this study is to compare the immune response over the three week study period in coeliac disease patients given Nexvax2 compared to those given saline.

Official Title
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A Phase I Study to Determine Safety, Tolerability and Bioactivity of Nexvax2 in HLA DQ2+ Volunteers With Coeliac Disease Following a Long-term, Strict Gluten-free Diet

Conditions
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Coeliac Disease, Celiac Disease

Intervention / Treatment
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* Biological: 9 micrograms Nexvax2
* Biological: 30 micrograms Nexvax2
* Biological: 90 micrograms Nexvax2
* Biological: 60 micrograms Nexvax2
* Biological: Up to 900 micrograms Nexvax2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age 18 to 60 years (inclusive) Have coeliac disease meeting the following criteria: the Principal Investigator is satisfied coeliac disease has been correctly diagnosed, HLA DQ2 genotype (both HLA DQA1*05 and DQB1*02, homo- or hetero-zygous), no known or suspected gluten exposure for 2 months prior to enrolment were prescribed and have intended to follow a gluten-free diet for at least one year antibodies to tissue transglutaminase (tTG) IgA and/or deamidated gliadin peptide (DGP) IgA and IgG within normal reference range at time of screening. Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. Key Exclusion Criteria: Subjects possess the genes encoding HLA DQ8 (either DQA1*03 or DQB1*0302). Uncontrolled complications of coeliac disease which, in the opinion of the Investigator, would impact immune response or pose an increased risk to the subject. Systemic biological agents less than 6 months prior to Day 1. Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to Day 1. Any of the following laboratory abnormalities at Screening: ALT, AST or alkaline phosphatase (ALP) > 1.5 times the upper limit of normal (ULN) Calculated creatinine clearance < 80 mL/min Haemoglobin (Hb) outside of the normal range Platelet count <125 x 109/L Serum potassium outside of the normal range White blood cell (WBC) count outside of the normal range Thyroid stimulating hormone (TSH) outside of the normal range Any other clinically significant abnormal lab values, as determined by the Clinical Investigator. Subjects who smoke or who have smoked at all in the past 3 months. Positive pregnancy test at Screening or Baseline. History of any medically significant condition considered by the Investigator to adversely affect participation in the trial. Non-compliance with a gluten free diet or flare in coeliac disease symptoms from Screening to Baseline. Clinically relevant abnormality on ECGs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Other: Placebo<br>* 100 microlitres 0.9% sterile sodium chloride for injection<br>|
| Experimental: Nexvax2<br> | Biological: 9 micrograms Nexvax2<br>* 9 micrograms, weekly intra-dermal injection, 3 week duration<br>Biological: 30 micrograms Nexvax2<br>* 30 micrograms, weekly intra-dermal injection, 3 week duration<br>Biological: 90 micrograms Nexvax2<br>* 90 micrograms, weekly intra-dermal injection, 3 week duration<br>Biological: 60 micrograms Nexvax2<br>* 60 micrograms, weekly intra-dermal injection, 3 week duration<br>Biological: Up to 900 micrograms Nexvax2<br>* Up to 900 micrograms, weekly intra-dermal injection, 3 week duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |