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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05425446
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05425446
Ethics application status
Date submitted
13/06/2022
Date registered
21/06/2022
Date last updated
29/05/2024
Titles & IDs
Public title
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
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Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
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Secondary ID [1]
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DQB101US
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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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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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0
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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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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DONQ52
Treatment: Drugs - Placebo
Experimental: SAD Cohort 1 - All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Experimental: SAD Cohort 2 - All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Experimental: SAD Cohort 3 - All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Experimental: SAD Cohort 4 - All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Experimental: MAD Cohort 1 - All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Experimental: MAD Cohort 2 - All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Experimental: MAD Cohort 3 - All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Treatment: Drugs: DONQ52
Subcutaneous (SC) injection
Treatment: Drugs: Placebo
Subcutaneous (SC) injection
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Intervention code [1]
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Treatment: Drugs
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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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Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
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Assessment method [1]
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Incidence and severity of TEAEs and its relationship to the study drugs
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Timepoint [1]
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Up to 246 days
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Primary outcome [2]
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Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
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Assessment method [2]
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Abnormality in vital signs
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Timepoint [2]
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Up to 246 days
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Primary outcome [3]
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Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
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Assessment method [3]
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Abnormality in Electrocardiograms (ECGs)
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Timepoint [3]
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Up to 246 days
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Primary outcome [4]
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Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
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Assessment method [4]
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Incidence of laboratory abnormalities, based on clinical laboratory tests
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Timepoint [4]
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Up to 246 days
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Secondary outcome [1]
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Pharmacokinetics; Serum DONQ52 concentration
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Assessment method [1]
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Serum DONQ52 concentrations over time
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Timepoint [1]
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Up to 246 days
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Secondary outcome [2]
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Pharmacokinetics; Maximum serum concentration [Cmax]
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Assessment method [2]
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Cmax of DONQ52
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Timepoint [2]
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Up to 246 days
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Secondary outcome [3]
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Pharmacokinetics; Time to maximum serum concentration [Tmax]
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Assessment method [3]
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Tmax of DONQ52
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Timepoint [3]
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Up to 246 days
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Secondary outcome [4]
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Pharmacokinetics; Area under the serum concentration time curve [AUC]
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Assessment method [4]
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AUC of DONQ52
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Timepoint [4]
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Up to 246 days
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Secondary outcome [5]
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Pharmacokinetics; Half life [T1/2]
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Assessment method [5]
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T1/2 of DONQ52
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Timepoint [5]
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Up to 246 days
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Secondary outcome [6]
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Immunogenicity
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Assessment method [6]
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Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52
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Timepoint [6]
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Up to 246 days
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Eligibility
Key inclusion criteria
- History of medically diagnosed celiac disease based on biopsies and positive celiac
serology.
- Be on a GFD for at least 12 months
- HLA-DQ2.5 genotype
- Experienced at most mild symptoms of celiac disease
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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
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin
peptide-IgA, and deamidated gliadin peptide-IgG)
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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 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
Active, not recruiting
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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
19/09/2022
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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
31/05/2024
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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University of Sunshine Coast Clinical Trials Centre - Morayfield - Morayfield
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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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2560 - Campbelltown
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Recruitment postcode(s) [2]
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4506 - Morayfield
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Idaho
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Country [5]
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United States of America
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State/province [5]
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Louisiana
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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South Carolina
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Country [11]
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United States of America
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State/province [11]
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Tennessee
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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United States of America
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State/province [13]
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Utah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Chugai Pharmaceutical
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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
This study is to characterize the safety and tolerability of an investigational drug called
DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose
part (Part B) in well-controlled celiac disease patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05425446
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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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Sponsor Chugai Pharmaceutical Co. Ltd
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Address
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[email protected]
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05425446
Additional trial details provided through ANZCTR
Accrual to date
4
Recruiting in Australia
Recruitment state(s)
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Chugai Pharmaceutical Co., Ltd
Primary sponsor address
1-1 Nihonbashi-Muromachi 2-Chome
Chuo-ku, Tokyo 103-8324
JAPAN
Primary sponsor country
Japan
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
66
Bellberry Ltd
Address [1]
66
123 Glen Osmond Rd, Eastwood SA 5063
Country [1]
66
Australia
Date submitted for ethics approval [1]
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14/06/2023
Approval date [1]
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03/08/2023
Ethics approval number [1]
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2023-06-682
Public notes
Contacts
Principal investigator
Title
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Dr
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Name
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Nabil Siddique
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Address
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Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
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Country
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Australia
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Phone
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(08) 6382 5100
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Dr
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Name
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Nabil Siddique
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Address
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Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
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Country
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Australia
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Phone
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(08) 6382 5100
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Nabil Siddique
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Address
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Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
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Country
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Australia
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Phone
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(08) 6382 5100
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Fax
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Email
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[email protected]
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