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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02528799




Registration number
NCT02528799
Ethics application status
Date submitted
17/08/2015
Date registered
19/08/2015
Date last updated
24/12/2018

Titles & IDs
Public title
Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease
Scientific 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
Secondary ID [1] 0 0
U1111-1173-7522
Secondary ID [2] 0 0
Nexvax2-1004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nexvax2
Other interventions - Nexvax2 placebo

Experimental: Nexvax2 DQ2.5 Homozygotes (Cohort 1) - Nexvax2 by ID injections for a total of 14 doses over 46 days.

Placebo Comparator: Nexvax2 Placebo DQ2.5 Homozygotes (Cohort 1) - Nexvax2 Placebo by ID injections for a total of 14 doses over 46 days.

Experimental: Nexvax2 DQ2.5 Non-homozygotes (Cohort 2) - Nexvax2 by ID injections for a total of 14 doses over 46 days.

Placebo Comparator: Nexvax2 Placebo DQ2.5 Non-homozygotes (Cohort 2) - Nexvax2 Placebo by ID injections for a total of 14 doses over 46 days.

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).

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).


Other interventions: Nexvax2
Nexvax2 intra-dermal injections twice weekly

Other interventions: Nexvax2 placebo
Sodium chloride 0.9% intra-dermal injections twice weekly

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Treatment Period (~7 to 9 weeks)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Treatment Period (~7 to 9 weeks)
Secondary outcome [2] 0 0
Plasma Cytokine Levels - The relative change from pre-dose levels up to 10 hours after dosing in the concentration of plasma cytokines.
Timepoint [2] 0 0
Treatment Period (~7 to 9 weeks)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Herston
Recruitment hospital [2] 0 0
CMAX, A Division of IDT Australia Ltd - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmusanT, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02528799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert P. Anderson, MB ChB, PhD
Address 0 0
ImmusanT, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications