Safety Study of Nexvax2 in Subjects With Coeliac Disease

This study has been completed.
Sponsor:
Information provided by:
Nexpep Pty Ltd
ClinicalTrials.gov Identifier:
NCT00879749
First received: April 8, 2009
Last updated: April 5, 2011
Last verified: April 2011

April 8, 2009
April 5, 2011
April 2009
March 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00879749 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Nexvax2 in Subjects With Coeliac Disease
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coeliac Disease
  • Celiac Disease
  • Biological: 9 micrograms Nexvax2
    9 micrograms, weekly intra-dermal injection, 3 week duration
  • Biological: 30 micrograms Nexvax2
    30 micrograms, weekly intra-dermal injection, 3 week duration
  • Biological: 90 micrograms Nexvax2
    90 micrograms, weekly intra-dermal injection, 3 week duration
  • Biological: 60 micrograms Nexvax2
    60 micrograms, weekly intra-dermal injection, 3 week duration
  • Biological: Up to 900 micrograms Nexvax2
    Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
  • Other: Placebo
    100 microlitres 0.9% sterile sodium chloride for injection
  • Placebo Comparator: Saline
    Intervention: Other: Placebo
  • Experimental: Nexvax2
    Interventions:
    • Biological: 9 micrograms Nexvax2
    • Biological: 30 micrograms Nexvax2
    • Biological: 90 micrograms Nexvax2
    • Biological: 60 micrograms Nexvax2
    • Biological: Up to 900 micrograms Nexvax2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2010
March 2010   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  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 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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00879749
Nexvax2-001
No
Robert Anderson/Chief Executive Officer, Nexpep Pty Ltd
Nexpep Pty Ltd
Not Provided
Principal Investigator: Gregor Brown, MBBS PhD FRACP The Alfred Hospital, Victoria
Principal Investigator: James Daveson, MBBS FRACP Princess Alexandra Hospital, Queensland
Nexpep Pty Ltd
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP