Safety Study of Nexvax2 in Subjects With Coeliac Disease

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879749
• Other study ID #: Nexvax2-001
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2009
• Last updated: April 5, 2011
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2011
• Source: Nexpep Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Celiac Disease
• Coeliac Disease

Intervention

Biological:
• 9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration
• 30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration
• 90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration
• 60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration
• 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

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston	Queensland
Australia	Nucleus Network - Centre for Clinical Studies	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Nexpep Pty Ltd

Country where clinical trial is conducted

Australia, 

External Links

•   Nexpep Pty Ltd