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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00879749




Registration number
NCT00879749
Ethics application status
Date submitted
8/04/2009
Date registered
10/04/2009
Date last updated
7/04/2011

Titles & IDs
Public title
Safety Study of Nexvax2 in Subjects With Coeliac Disease
Scientific title
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
Secondary ID [1] 0 0
Nexvax2-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 0 0
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
Treatment: Other - 9 micrograms Nexvax2
Treatment: Other - 30 micrograms Nexvax2
Treatment: Other - 90 micrograms Nexvax2
Treatment: Other - 60 micrograms Nexvax2
Treatment: Other - Up to 900 micrograms Nexvax2
Other interventions - Placebo

Placebo comparator: Saline -

Experimental: Nexvax2 -


Treatment: Other: 9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration

Treatment: Other: 30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration

Treatment: Other: 90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration

Treatment: Other: 60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration

Treatment: Other: Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: Placebo
100 microlitres 0.9% sterile sodium chloride for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

1. Age 18 to 60 years (inclusive)
2. 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.
3. 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects possess the genes encoding HLA DQ8 (either DQA1*03 or DQB1*0302).
2. Uncontrolled complications of coeliac disease which, in the opinion of the Investigator, would impact immune response or pose an increased risk to the subject.
3. Systemic biological agents less than 6 months prior to Day 1.
4. Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to Day 1.
5. 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.
6. Subjects who smoke or who have smoked at all in the past 3 months.
7. Positive pregnancy test at Screening or Baseline.
8. History of any medically significant condition considered by the Investigator to adversely affect participation in the trial.
9. Non-compliance with a gluten free diet or flare in coeliac disease symptoms from Screening to Baseline.
10. Clinically relevant abnormality on ECGs.

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
Parallel
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment hospital [2] 0 0
Nucleus Network - Centre for Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nexpep Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00879749
Trial related presentations / publications
Tye-Din JA, Stewart JA, Dromey JA, Beissbarth T, van Heel DA, Tatham A, Henderson K, Mannering SI, Gianfrani C, Jewell DP, Hill AV, McCluskey J, Rossjohn J, Anderson RP. Comprehensive, quantitative mapping of T cell epitopes in gluten in celiac disease. Sci Transl Med. 2010 Jul 21;2(41):41ra51. doi: 10.1126/scitranslmed.3001012.
Public notes

Contacts
Principal investigator
Name 0 0
Gregor Brown, MBBS PhD FRACP
Address 0 0
The Alfred Hospital, Victoria
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00879749