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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03543540




Registration number
NCT03543540
Ethics application status
Date submitted
26/04/2018
Date registered
1/06/2018

Titles & IDs
Public title
Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease
Scientific title
A Phase 1 Study of Nexvax2 Administered Subcutaneously After a Screening Gluten Food Challenge That Compares Relative Bioavailability With Intradermal Administration in Non-homozygous HLA-DQ2.5+ Adults With Celiac Disease
Secondary ID [1] 0 0
Nexvax2-1005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Intestinal Disease 0 0
Malabsorption Syndromes 0 0
Gastrointestinal Disease 0 0
Digestive System Diseases 0 0
Metabolic Disease 0 0
Coeliac Disease 0 0
Gluten Sensitivity 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nexvax2
Treatment: Other - Placebo

Experimental: Nexvax2 (Arm A) -

Experimental: Nexvax2 (Arm B) -

Placebo comparator: Nexvax2 Placebo (Arm C) -

Placebo comparator: Nexvax2 Placebo (Arm D) -


Treatment: Other: Nexvax2
Nexvax2 injections: 14 in total at twice weekly intervals

Treatment: Other: Placebo
Placebo injections: 14 in total at twice weekly intervals
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Nexvax 2 administered subcutaneously (SQ)
Timepoint [1] 0 0
Treatment Period: 7 weeks
Primary outcome [2] 0 0
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
Timepoint [2] 0 0
Treatment Period: 7 weeks
Secondary outcome [1] 0 0
Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
Timepoint [1] 0 0
Treatment Period: 7 weeks
Secondary outcome [2] 0 0
Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Timepoint [2] 0 0
Treatment Period: 7 weeks
Secondary outcome [3] 0 0
Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Timepoint [3] 0 0
Treatment Period: 7 weeks
Secondary outcome [4] 0 0
Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
Timepoint [4] 0 0
Treatment Period: 7 weeks

Eligibility
Key inclusion criteria
* Adults 18 to 70 years of age (inclusive)
* History of medically diagnosed Celiac Disease (CeD) that included duodenal biopsy.
* Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
* Willingness to consume a moderate amount of gluten on one occasion during screening.
* Able to read and understand English.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of inflammatory bowel disease and/or microscopic colitis.
* Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
* Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
* Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
* Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
* Females who are lactating or pregnant
* Receipt of any vaccine within 1 week prior to planned first day of the treatment period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2018
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Qpharm Pty Ltd - Herston
Recruitment hospital [2] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmusanT, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Anderson, PhD, FRACP
Address 0 0
ImmusanT, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03543540