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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability in Patients With Celiac Disease
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability in Patients With Celiac Disease
Secondary ID [1] 280228 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 286175 0
Condition category
Condition code
Inflammatory and Immune System 286370 286370 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 286382 286382 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
The study will consist of a Screening Period, Treatment Period, and a Follow-up Period. Escalating dose cohorts will receive active (12 patients per cohort) or placebo given intradermally in a 2:1 ratio. Patients will receive the same dose for the whole Treatment period. During the Screening period medical history, physical examination, vital sign measurements, ECG, and laboratory assessment will be performed as safety assessments. These assessments will also be performed during the study. Adverse events and concomitant medications will be assessed from the Screening visit until the end of the study.
Intervention code [1] 284561 0
Treatment: Drugs
Comparator / control treatment
Placebo: Sodium chloride 0.9% USP (same as vehicle/diluent), dosed at same time as active treatment.
Control group

Primary outcome [1] 286825 0
The number and percentage of Adverse Events collected during the Treatment Period. At each visit, patients will be asked standard questions: Have you had any health problems since the previous visit or when you were last asked? and Have you had any new symptoms? to elicit any medically related changes in their well-being. Responses and details will be recorded in the database. Any clinically significant results from any safety assessments may be recorded as an Adverse Event, based on the investigator's medical opinion. Expected Adverse Events are headache and abdominal pain.
Timepoint [1] 286825 0
Adverse Events will be monitored from the time of signing the Informed consent Form until the end of the study.
Secondary outcome [1] 296743 0
Results of safety and tolerability assessments collected during the Treatment Period.
Timepoint [1] 296743 0
Safety and tolerability assessments performed at each visit.
Secondary outcome [2] 296744 0
The PK endpoints are plasma drug concentrations and PK parameters in patients who received active drug.
Timepoint [2] 296744 0
Pharmacokinetic blood samples will be drawn at different timepoints during the study.

Key inclusion criteria
Diagnosis of Celiac Disease
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patient has not been prescribed and/or has not followed a GFD for at least 12 months.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be allocated to active or placebo using an IVRS system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generated by IVRS/IWRS system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Dose escalation study.
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5158 0

Funding & Sponsors
Funding source category [1] 284984 0
Commercial sector/Industry
Name [1] 284984 0
ImmusanT, Inc
Address [1] 284984 0
One Broadway, 14th Floor
Cambridge, MA 02142
Country [1] 284984 0
United States of America
Primary sponsor type
Commercial sector/Industry
ImmusanT, Inc
One Broadway, 14th Floor
Cambridge, MA 02142
United States of America
Secondary sponsor category [1] 283848 0
Name [1] 283848 0
Address [1] 283848 0
Country [1] 283848 0

Ethics approval
Ethics application status
Ethics committee name [1] 286993 0
Bellberry Limited
Ethics committee address [1] 286993 0
229 Greenhill Road Dulwich SA 5065
Ethics committee country [1] 286993 0
Date submitted for ethics approval [1] 286993 0
Approval date [1] 286993 0
Ethics approval number [1] 286993 0

Brief summary
This a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability in patients with celiac disease who are on a gluten-free diet.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33986 0
Dr James Daveson
Address 33986 0
Q-Pharm Pty Ltd
PO Box 78
Royal Brisbane Hospital
Herston QLD 4029
Country 33986 0
Phone 33986 0
+61 7 33671065
Fax 33986 0
Email 33986 0
Contact person for public queries
Name 17233 0
Ms Sandrien Louwaars
Address 17233 0
CPR Pharma Services
Suite C, 32 West Thebarton Road
Country 17233 0
Phone 17233 0
+61 8 8125 1907
Fax 17233 0
Email 17233 0
Contact person for scientific queries
Name 8161 0
Dr Patrick Griffin
Address 8161 0
ImmusanT, Inc
One Broadway
14th Floor
Cambridge, MA 02142
Country 8161 0
United States of America
Phone 8161 0
+1 646-541-4588
Fax 8161 0
Email 8161 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary