Safety Study of Nexvax2 in Subjects With Coeliac Disease

• ClinicalTrials.gov Identifier: NCT00879749
• Recruitment Status: Completed
• First Posted: April 10, 2009
• Last Update Posted: April 7, 2011
• Sponsor: Nexpep Pty Ltd
• Information provided by: Nexpep Pty Ltd

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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: April 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Robert Anderson/Chief Executive Officer, Nexpep Pty Ltd
• ClinicalTrials.gov Identifier: NCT00879749
• Other Study ID Numbers: Nexvax2-001
• First Posted: April 10, 2009
• Last Update Posted: April 7, 2011
• Last Verified: April 2011

Additional relevant MeSH terms:

Celiac Disease; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases