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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
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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
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Secondary ID [1]
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Nexvax2-1005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Celiac Disease
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Intestinal Disease
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Malabsorption Syndromes
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Gastrointestinal Disease
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Digestive System Diseases
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Metabolic Disease
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Coeliac Disease
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Gluten Sensitivity
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety of Nexvax 2 administered subcutaneously (SQ)
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Assessment method [1]
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Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.
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Timepoint [1]
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Treatment Period: 7 weeks
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Primary outcome [2]
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Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
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Assessment method [2]
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Blood draws for plasma concentration
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Timepoint [2]
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Treatment Period: 7 weeks
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Secondary outcome [1]
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Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID
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Assessment method [1]
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Blood draw collected for cytokines
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Timepoint [1]
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Treatment Period: 7 weeks
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Secondary outcome [2]
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Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.
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Assessment method [2]
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Blood draw collected for Pharmacokinetic (PK) sample
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Timepoint [2]
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Treatment Period: 7 weeks
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Secondary outcome [3]
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Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.
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Assessment method [3]
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Blood draw collected for PK
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Timepoint [3]
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Treatment Period: 7 weeks
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Secondary outcome [4]
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Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.
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Assessment method [4]
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Blood draw collected for PK
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Timepoint [4]
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Treatment Period: 7 weeks
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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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/09/2018
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
QLD,WA
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Recruitment hospital [1]
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Qpharm Pty Ltd - Herston
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Recruitment hospital [2]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [3]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment postcode(s) [2]
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4556 - Sippy Downs
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ImmusanT, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
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Trial website
https://clinicaltrials.gov/study/NCT03543540
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Anderson, PhD, FRACP
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Address
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ImmusanT, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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