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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05251259




Registration number
NCT05251259
Ethics application status
Date submitted
20/12/2021
Date registered
22/02/2022

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
Scientific title
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults With Moderate to Severe Uncontrolled Asthma
Secondary ID [1] 0 0
2023-509243-27-00
Secondary ID [2] 0 0
D7552C00001
Universal Trial Number (UTN)
Trial acronym
FLASH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

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

Experimental: Lead-in PK Cohort (Atuliflapon) - Randomised participants will receive Atuliflapon

Experimental: Part 1: Atuliflapon - Randomised participants will receive Atuliflapon

Placebo comparator: Lead-in PK, Part 1 Placebo - Randomised participants will receive placebo


Treatment: Drugs: Atuliflapon
Randomised participants will receive Atuliflapon

Treatment: Drugs: Placebo
Randomised participants will receive placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first CompEx Asthma event
Timepoint [1] 0 0
Baseline up to Week 12
Secondary outcome [1] 0 0
Time to first CompEx Asthma event (Composite endpoint for Exacerbations)
Timepoint [1] 0 0
Baseline up to Week 12
Secondary outcome [2] 0 0
Time to first CompEx Asthma event (Composite endpoint for Exacerbations)
Timepoint [2] 0 0
Baseline up to Week 12
Secondary outcome [3] 0 0
Change from baseline in Pre-bronchodilator forced expiratory volume in 1 second
Timepoint [3] 0 0
Baseline, Week 4 and Week 12
Secondary outcome [4] 0 0
Change from baseline in St. George's Respiratory Questionnaire
Timepoint [4] 0 0
Baseline, Week 4 and Week 12
Secondary outcome [5] 0 0
Change from baseline in Asthma Control Questionnaire 6
Timepoint [5] 0 0
Baseline Week 4, Week 8, Week 12
Secondary outcome [6] 0 0
Change from baseline in average morning and evening Peak Expiratory Flow Measurement
Timepoint [6] 0 0
Baseline Week 4, Week 8, Week 12
Secondary outcome [7] 0 0
Change from baseline in Daily asthma symptom score (total, daytime, and night-time)
Timepoint [7] 0 0
Baseline Week 4, Week 8, Week 12
Secondary outcome [8] 0 0
Time to first severe asthma exacerbation
Timepoint [8] 0 0
Baseline up to Week 12
Secondary outcome [9] 0 0
Event status (CompEx Asthma event yes/no)
Timepoint [9] 0 0
Baseline up to Week 12
Secondary outcome [10] 0 0
Lead-in PK: Area under the curve (AUC)
Timepoint [10] 0 0
Day 1 and Day 15
Secondary outcome [11] 0 0
Lead-in PK: Maximum (or peak) serum concentration (Cmax)
Timepoint [11] 0 0
Day 1 and Day 15
Secondary outcome [12] 0 0
Lead-in PK cohort: Pre-dose trough concentration (Ctrough)
Timepoint [12] 0 0
Day 15
Secondary outcome [13] 0 0
Part 1 Cohort: Atuliflapon plasma concentrations in all participants, pre-dose samples
Timepoint [13] 0 0
Baseline, Week 4 and Week 12
Secondary outcome [14] 0 0
Number of participants with adverse events (AEs)
Timepoint [14] 0 0
Baseline up to Week 12

Eligibility
Key inclusion criteria
Inclusion Criteria

Lead-in PK Cohort:

* 18 to 55 years of age inclusive at the time of signing the informed consent at screening Visit 1.
* Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m^2 (inclusive) at screening Visit 1.
* Documented asthma diagnosis =12 months prior to screening Visit 1.
* Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society / European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
* Morning pre- bronchodilator (BD) forced expiratory volume (FEV)1 = 40% predicted at screening Visit 1 and Visit 2.
* Treated with low dose inhaled corticosteroid plus long-acting ß2-agonist (ICS-LABA) or medium-high dose ICS alone or in combination with LABA at a stable dose for at least 3 months prior to screening Visit 1. Also, treatment with additional asthma controller therapies (eg, LAMA) at a stable dose = 3 months prior to screening Visit 1 is allowed.
* Participant's influenza/pneumonia vaccination is up to date as per local guidelines prior to Visit 2.

General Inclusion Criteria for Part 1:

* Body weight = 40 kg and body mass index (BMI) < 35 kg/m^2.
* Documented history of = 1 severe asthma exacerbation within 1 year prior to screening Visit 1.
* Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria.
* Morning pre-BD FEV1 between = 40% and = 85% predicted at screening Visit 1 and Visit 3.
* An Asthma Control Questionnaire (ACQ)-6 score = 1.5 at screening Visit 1 and at Visit 3.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* A severe asthma exacerbation within 8 weeks of screening (visit 1) or within 12 weeks of randomisation (Visit 3).
* A positive test result of an approved antigen test (confirmed by a positive RT-PCR test) or a positive RT-PCR test for SARS-CoV-2, the virus responsible for COVID-19, at screening Visit 1 or at Visit 2 for the PK Lead-in cohort. For Part 1 the testing will be done at Visit 3. Results from the mandatory tests at Visit 2 (PK Lead-in cohort) and Visit 3 (Part 1) must not be older than 48 hours and must be available before randomisation.
* Participants with a significant COVID-19 illness within 6 months of enrolment.
* Clinically important pulmonary disease other than asthma.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable.
* Any clinically significant cardiac disease.
* History of severe renal disease or history of creatinine clearance < 30 mL/min × m2 calculated using Cockcroft-Gault equation.
* Severe hepatic impairment (Child-Pugh class C).
* Previous hepatotoxicity related to zileuton or leukotriene receptor antagonist (LTRAs) (eg montelukast).
* Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Evidence of active or untreated latent tuberculosis (TB).
* Current or history of alcohol or drug abuse (including marijuana).
* Current diagnosis of cancer, not including in-situ or non-melanoma skin cancer or other previous malignancies where curative therapy was completed at least 5 years prior to screening Visit 1.
* Clinically important ongoing or previous psychiatric disease, especially suicidal behaviour, that in the opinion of the investigator might compromise the safety of the participant in the study.
* Treatment with any serum creatinine-altering drugs within 1 month prior to screening Visit 1 including but not limited to amphotericin, cimetidine, clofibrate, dronedarone, ketoconazole, probenecid, ranolazine, trimethoprim, aminoglycosides, or cephalosporins.
* Treatment with systemic corticosteroid use within 8 weeks (oral) or 12 weeks (intramuscular) before screening (Visit 1) or 12 weeks (oral) or 16 weeks (IM) before randomization (Visit 3).
* Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, and dupilumab within 6 months of screening Visit 1 or 5 half-lives whichever is longer.
* Treatment with 5-lipoxygenase inhibitors (eg zileuton or other 5-LO inhibiting supplements) within 6 weeks prior to Visit 0 and within 8 weeks prior to Visit 1).Treatment with LTRAs (eg, montelukast) within 2 weeks prior to Visit 0 and within 4 weeks prior to screening Visit 1.
* Inhaled corticosteroid + fast-acting ß2 agonist as a reliever (eg Symbicort or Fostair Maintenance and Reliever Treatment) is not allowed 15 days prior to screening Visit 1, during screening (Visit 1)/run-in and the treatment period and preferably 1 week after the last dose of study intervention.
* Live or attenuated vaccines within 4 weeks of screening Visit 1.
* Immunoglobulin or blood products within 4 weeks of screening Visit 1.
* Treatment with Gemfibrozil within 4 weeks of screening Visit 1.
* Any immunotherapy within 6 months of screening Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to screening Visit 1 and expected to continue through to the end of the follow-up period.
* Potent inducers/inhibitors of cytochrome P450 3A4 within 4 weeks of screening Visit 1.
* Treatment with simvastatin, lovastatin, and atorvastatin at doses > 40 mg per day within 1 month prior to screening Visit 1. Treatment with sensitive cytochrome 3A substrates with narrow therapeutic window should be avoided from randomization to study drug.
* For female participants on ethinyl oestradiol containing combined oral contraceptives.
* Concurrent enrolment in another clinical study.
* Previous participation in the current clinical study.
* Participant treated with any investigational drug within 4 months prior to screening Visit 1.
* Known history of allergy or reaction to any component of the study intervention formulation.
* For female participants only: Currently pregnant or breast-feeding.
* Smokers with smoking history of < 10 pack-years or users of vaping or e-cigarettes, must have stopped at least 6 months prior to screening Visit 1.
* Involvement in the planning and/or conduct of the study.
* Donation of blood (= 450 mL) within 3 months or donation of plasma within 14 days before screening Visit 1.
* Major surgery within 8 weeks prior to screening Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during the screening (Visit 1), treatment or follow-up periods.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2025
Actual
Sample size
Target
666
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Mitcham
Recruitment hospital [4] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3132 - Mitcham
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Incheon
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Jeonju
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Baia Mare
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
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 can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT05251259