Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
FLASH
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
3 other identifiers
interventional
670
20 countries
234
Brief Summary
This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered once daily over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jan 2022
Longer than P75 for phase_2 asthma
234 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Start
First participant enrolled
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2026
CompletedJanuary 14, 2026
January 1, 2026
3.9 years
December 20, 2021
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first CompEx Asthma event
The clinical efficacy of Atuliflapon Dose A will be assessed by calculating a Hazard Ratio between the treatment arms, Atuliflapon Dose A vs. placebo, in a selected population (based on biomarker level). CompEx Asthma, a novel composite endpoint for exacerbations, captures asthma-worsening episodes based on a combination of diary events (worsening in daily peak expiratory flow (PEF), asthma symptoms and reliever medication use) plus severe asthma exacerbation events.
Baseline up to Week 12
Secondary Outcomes (14)
Time to first CompEx Asthma event (Composite endpoint for Exacerbations)
From Baseline up to Week 12
Time to first CompEx Asthma event (Composite endpoint for Exacerbations)
From Baseline up to Week 12
Change from baseline in Pre-bronchodilator in forced expiratory volume in 1 second (FEV1)
From Baseline up to Week 2, Week 4 and Week 12
Change from baseline in St. George's Respiratory Questionnaire
From Baseline up to Week 4 and Week 12
Change from baseline in Asthma Control Questionnaire 6
From Baseline up to Week 4, Week 8, Week 12
- +9 more secondary outcomes
Study Arms (4)
Lead-in PK cohort (Atuliflapon)
EXPERIMENTALRandomised participants will receive Atuliflapon in Lead-in PK period of the study.
Lead-in PK cohort (Placebo)
PLACEBO COMPARATORRandomised participants will receive matching placebo to Atuliflapon in Lead-in PK cohort of the study.
Part 1 (Atuliflapon)
EXPERIMENTALRandomised participants will receive Atuliflapon in Part 1 of the study.
Part 1 (Placebo)
PLACEBO COMPARATORRandomised participants will receive matching placebo to Atuliflapon in Part 1 of the study.
Interventions
Randomised participants will receive Atuliflapon
Randomised participants will receive matching placebo to Atuliflapon.
Eligibility Criteria
You may qualify if:
- Lead-in PK Cohort:
- 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 β2-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.
- 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.
You may not qualify if:
- 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 tuberculosis (TB), either treated or untreated or latent 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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (234)
Research Site
Birmingham, Alabama, 35211, United States
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Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85020, United States
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Tucson, Arizona, 85741, United States
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Little Rock, Arkansas, 72212, United States
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Bakersfield, California, 93301, United States
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Fountain Valley, California, 92708, United States
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Huntington Beach, California, 92647, United States
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Los Angeles, California, 90025, United States
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Newport Beach, California, 92663, United States
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San Jose, California, 95117, United States
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Valencia, California, 91355, United States
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Colorado Springs, Colorado, 80907, United States
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Cutler Bay, Florida, 33157, United States
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Cutler Bay, Florida, 33189, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33015, United States
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Hialeah, Florida, 33016, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33174, United States
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Orlando, Florida, 32807, United States
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Tampa, Florida, 33613, United States
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Tampa, Florida, 33615, United States
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Fayetteville, Georgia, 30214, United States
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Lithonia, Georgia, 30038, United States
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Savannah, Georgia, 31406, United States
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Boise, Idaho, 83706, United States
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Lexington, Kentucky, 40509, United States
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Owensboro, Kentucky, 42301, United States
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Oxon Hill, Maryland, 20745, United States
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New Bedford, Massachusetts, 02740, United States
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Ann Arbor, Michigan, 48105, United States
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Farmington Hills, Michigan, 48336, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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East Orange, New Jersey, 07018, United States
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Toms River, New Jersey, 08755, United States
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The Bronx, New York, 10459, United States
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Valhalla, New York, 10595, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28287, United States
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Gastonia, North Carolina, 28054, United States
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Wilmington, North Carolina, 28401, United States
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Blue Ash, Ohio, 45242, United States
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Dayton, Ohio, 45439, United States
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Edmond, Oklahoma, 73034, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29615, United States
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Spartanburg, South Carolina, 29303, United States
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Austin, Texas, 78705, United States
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Beaumont, Texas, 77701, United States
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Bellaire, Texas, 77401, United States
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Dallas, Texas, 75225, United States
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El Paso, Texas, 79902, United States
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El Paso, Texas, 79903, United States
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Houston, Texas, 77022, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78258, United States
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Sugar Land, Texas, 77479, United States
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Tomball, Texas, 77375, United States
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Milwaukee, Wisconsin, 53228, United States
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Bahía Blanca, 8000, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1414AIF, Argentina
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CABA, 1008, Argentina
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Capital Federal, C1122AAK, Argentina
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Ciudad Capital, 5500, Argentina
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Ciudad de Buenos Aire, C1425BEN, Argentina
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Concepción del Uruguay, 3260, Argentina
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Córdoba, X5003DCE, Argentina
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Florida, B1602DQD, Argentina
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Godoy Cruz, M5501ARP, Argentina
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La Plata, B1900, Argentina
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La Plata, B1902COS, Argentina
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Lobos, 7240, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600, Argentina
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Mendoza, 5500, Argentina
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Mendoza, 5501, Argentina
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Mendoza, M5500CCG, Argentina
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Pilar, B1629AHJ, Argentina
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Quilmes, B1878FNR, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, 2000, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Santa Fe, 3000, Argentina
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Adelaide, 5000, Australia
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Clayton, 3168, Australia
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Kozloduy, 3320, Bulgaria
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Montana, 3400, Bulgaria
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Plovdiv, 4000, Bulgaria
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Rousse, 7000, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1407, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Velingrad, 4691, Bulgaria
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Vidin, 3700, Bulgaria
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Quillota, 2260000, Chile
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Santiago, 7500698, Chile
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Santiago, 7530234, Chile
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Santiago, 8330336, Chile
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Talca, 3481349, Chile
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Temuco, 4802815, Chile
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Viña del Mar, 2531172, Chile
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Vitacura, 7630226, Chile
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Klenovnik, 42244, Croatia
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Petrinja, 44250, Croatia
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Rijeka, 51000, Croatia
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Split, 21000, Croatia
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Zagreb, 10 000, Croatia
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Berlin, 12159, Germany
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Frankfurt, 60313, Germany
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Leipzig, 04103, Germany
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Lübeck, 23552, Germany
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Marburg, 35037, Germany
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Hajdúnánás, 4080, Hungary
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Pécs, 7635, Hungary
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Szombathely, 9700, Hungary
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Bunkyō City, 113-8510, Japan
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Chūōku, 103-0022, Japan
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Chūōku, 104-0031, Japan
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Fukuoka, 811-1351, Japan
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Fukuoka, 815-8588, Japan
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Fukuoka, 819-8555, Japan
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Himeji, 672-8064, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kobe, 653-0013, Japan
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Kodaira-shi, 187-0024, Japan
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Koga-shi, 811-3195, Japan
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Kokubunji-shi, 185-0014, Japan
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Kyoto, 601-8213, Japan
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Nakagun, 259-0114, Japan
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Niigata, 940-0840, Japan
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Osaka, 530-0001, Japan
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Osaka, 531-0073, Japan
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Sagamihara-shi, 252-0315, Japan
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Sapporo, 064-0801, Japan
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Setagaya-ku, 157-0072, Japan
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Shibuya-Ku, 150-0013, Japan
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Tokyo, 157-0066, Japan
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Tokyo, 160-0017, Japan
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Toshima-ku, 170-0002, Japan
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Toshima-ku, 170-0003, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 231-8682, Japan
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Bialystok, 15-044, Poland
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Gdansk, 80-382, Poland
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Grudziądz, 86-300, Poland
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Katowice, 40-282, Poland
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Katowice, 40-611, Poland
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Kielce, 25-751, Poland
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Krakow, 31-455, Poland
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Krakow, 31-513, Poland
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Ksawerów, 95-054, Poland
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Lodz, 90-127, Poland
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Lodz, 90-153, Poland
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Lodz, 90-302, Poland
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Ostróda, 14-100, Poland
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Poznan, 60-702, Poland
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Tarnów, 33-100, Poland
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Wroclaw, 50-381, Poland
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Wroclaw, 53-301, Poland
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Brasov, 500091, Romania
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Brasov, 500112, Romania
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Brasov, 500283, Romania
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Bucharest, 010626, Romania
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Bucharest, 014461, Romania
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Bucharest, 020125, Romania
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Bucharest, 061696, Romania
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Caracal, 235200, Romania
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Cluj-Napoca, 400371, Romania
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Deva, 330084, Romania
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Iași, 700115, Romania
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Resca, Com. Dobrosloveni, 237143, Romania
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Timișoara, 300310, Romania
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Belgrade, 11000, Serbia
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Belgrade, 11070, Serbia
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Užice, 31000, Serbia
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Valjevo, 14000, Serbia
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Levice, 934 01, Slovakia
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Prešov, 08001, Slovakia
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Topoľčany, 95501, Slovakia
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Germiston, 1401, South Africa
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Krugersdorp, 1740, South Africa
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Lenasia, 1827, South Africa
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Incheon, 405-760, South Korea
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Jeonju, 54907, South Korea
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Seoul, 02841, South Korea
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Seoul, 06591, South Korea
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Seoul, 138-736, South Korea
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Suwon, 16499, South Korea
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Badalona, 08916, Spain
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Barcelona, 08017, Spain
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Benalmádena, 29631, Spain
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Jerez de la Frontera, 11407, Spain
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Laredo, 39770, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Málaga, 29010, Spain
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Istanbul, 34093, Turkey (Türkiye)
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Chernivtsі, 58002, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Kyiv, 01135, Ukraine
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Vinnytsia, 21029, Ukraine
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Birmingham, B15 2SQ, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Cardiff, CF15 9SS, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, ML4 3NJ, United Kingdom
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Harefield, UB9 6JH, United Kingdom
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Hexham, NE46 1QJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Leicester, LE3 9QP, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, SW10 9NH, United Kingdom
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London, W1T 6AH, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M15 6SE, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Reading, RG1 5AN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
February 22, 2022
Study Start
January 27, 2022
Primary Completion
January 7, 2026
Study Completion
January 7, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.