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Trial details imported from ClinicalTrials.gov

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

Titles & IDs
Public title
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
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)
Secondary ID [1] 0 0
DQB101US
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Timepoint [1] 0 0
Up to 246 days
Primary outcome [2] 0 0
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Timepoint [2] 0 0
Up to 246 days
Primary outcome [3] 0 0
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Timepoint [3] 0 0
Up to 246 days
Primary outcome [4] 0 0
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Timepoint [4] 0 0
Up to 246 days
Secondary outcome [1] 0 0
Pharmacokinetics; Serum DONQ52 concentration
Timepoint [1] 0 0
Up to 246 days
Secondary outcome [2] 0 0
Pharmacokinetics; Maximum serum concentration [Cmax]
Timepoint [2] 0 0
Up to 246 days
Secondary outcome [3] 0 0
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Timepoint [3] 0 0
Up to 246 days
Secondary outcome [4] 0 0
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Timepoint [4] 0 0
Up to 246 days
Secondary outcome [5] 0 0
Pharmacokinetics; Half life [T1/2]
Timepoint [5] 0 0
Up to 246 days
Secondary outcome [6] 0 0
Immunogenicity
Timepoint [6] 0 0
Up to 246 days

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/01/2025
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
University of Sunshine Coast Clinical Trials Centre - Morayfield - Morayfield
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
4506 - Morayfield
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chugai Pharmaceutical
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Sponsor Chugai Pharmaceutical Co. Ltd
Address 0 0
clinical-trials@chugai-pharm.co.jp
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)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/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] 66
14/06/2023
Approval date [1] 66
03/08/2023
Ethics approval number [1] 66
2023-06-682
 
Public notes

Contacts
Principal investigator
Title 409 0
Dr
Name 409 0
Nabil Siddique
Address 409 0
Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
Country 409 0
Australia
Phone 409 0
(08) 6382 5100
Fax 409 0
Email 409 0
Nabil.Siddique@health.wa.gov.au
Contact person for public queries
Title 410 0
Dr
Name 410 0
Nabil Siddique
Address 410 0
Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
Country 410 0
Australia
Phone 410 0
(08) 6382 5100
Fax 410 0
Email 410 0
Nabil.Siddique@health.wa.gov.au
Contact person for scientific queries
Title 411 0
Dr
Name 411 0
Nabil Siddique
Address 411 0
Linear Clinical Research Ltd 1st Floor B Block, 1 Hospital Ave Nedlands WA 6009
Country 411 0
Australia
Phone 411 0
(08) 6382 5100
Fax 411 0
Email 411 0
Nabil.Siddique@health.wa.gov.au