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
  Purpose

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.


Condition Intervention Phase
Coeliac Disease
Celiac Disease
Biological: 9 micrograms Nexvax2
Biological: 30 micrograms Nexvax2
Biological: 90 micrograms Nexvax2
Biological: 60 micrograms Nexvax2
Biological: Up to 900 micrograms Nexvax2
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nexpep Pty Ltd:

Enrollment: 34
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Other: Placebo
100 microlitres 0.9% sterile sodium chloride for injection
Experimental: Nexvax2 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879749

Locations
Australia, Queensland
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006
Australia, Victoria
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Nexpep Pty Ltd
Investigators
Principal Investigator: Gregor Brown, MBBS PhD FRACP The Alfred Hospital, Victoria
Principal Investigator: James Daveson, MBBS FRACP Princess Alexandra Hospital, Queensland
  More Information

No publications provided by Nexpep Pty Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Anderson/Chief Executive Officer, Nexpep Pty Ltd
ClinicalTrials.gov Identifier: NCT00879749     History of Changes
Other Study ID Numbers: Nexvax2-001
Study First Received: April 8, 2009
Last Updated: April 5, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 28, 2014