Back to resultsSafety Study of Nexvax2 in Subjects With Coeliac Disease
Primary Purpose
Coeliac Disease, Celiac Disease
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
9 micrograms Nexvax2
30 micrograms Nexvax2
90 micrograms Nexvax2
60 micrograms Nexvax2
Up to 900 micrograms Nexvax2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coeliac Disease
Eligibility Criteria
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.
Sites / Locations
- Q-Pharm Pty Ltd
- Nucleus Network - Centre for Clinical Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline
Nexvax2
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00879749
Brief Title
Safety Study of Nexvax2 in Subjects With Coeliac Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nexpep Pty Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coeliac Disease, Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
Nexvax2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
9 micrograms Nexvax2
Intervention Description
9 micrograms, weekly intra-dermal injection, 3 week duration
Intervention Type
Biological
Intervention Name(s)
30 micrograms Nexvax2
Intervention Description
30 micrograms, weekly intra-dermal injection, 3 week duration
Intervention Type
Biological
Intervention Name(s)
90 micrograms Nexvax2
Intervention Description
90 micrograms, weekly intra-dermal injection, 3 week duration
Intervention Type
Biological
Intervention Name(s)
60 micrograms Nexvax2
Intervention Description
60 micrograms, weekly intra-dermal injection, 3 week duration
Intervention Type
Biological
Intervention Name(s)
Up to 900 micrograms Nexvax2
Intervention Description
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
100 microlitres 0.9% sterile sodium chloride for injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Brown, MBBS PhD FRACP
Organizational Affiliation
The Alfred Hospital, Victoria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Daveson, MBBS FRACP
Organizational Affiliation
Princess Alexandra Hospital, Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q-Pharm Pty Ltd
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Nucleus Network - Centre for Clinical Studies
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20650871
Citation
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.
Results Reference
derived
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Safety Study of Nexvax2 in Subjects With Coeliac Disease
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