Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
NCT ID: NCT05251259
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
670 participants
INTERVENTIONAL
2022-01-27
2026-01-07
Brief Summary
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Detailed Description
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The study will be initiated by Lead-in pharmacokinetics (PK) cohort in asthma participants. Participant will be randomised globally, including participants in Lead-in PK cohort (2 arms) and in Part 1 of the study (2 arms).
In the Lead-in PK cohort, participants will be randomised to Atuliflapon or placebo (recruitment completed).
In Part 1 of the study, participants will be stratified by geographical region, and grouped based on high or low levels of biomarker at screening (Visit 1).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lead-in PK cohort (Atuliflapon)
Randomised participants will receive Atuliflapon in Lead-in PK period of the study.
Atuliflapon
Randomised participants will receive Atuliflapon
Lead-in PK cohort (Placebo)
Randomised participants will receive matching placebo to Atuliflapon in Lead-in PK cohort of the study.
Placebo
Randomised participants will receive matching placebo to Atuliflapon.
Part 1 (Atuliflapon)
Randomised participants will receive Atuliflapon in Part 1 of the study.
Atuliflapon
Randomised participants will receive Atuliflapon
Part 1 (Placebo)
Randomised participants will receive matching placebo to Atuliflapon in Part 1 of the study.
Placebo
Randomised participants will receive matching placebo to Atuliflapon.
Interventions
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Atuliflapon
Randomised participants will receive Atuliflapon
Placebo
Randomised participants will receive matching placebo to Atuliflapon.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
Exclusion Criteria
* 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.
* 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 β2 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, the ethinyl oestradiol doses exceeding 20 mcg per day.
* 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.
* 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.
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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San Jose, California, United States
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Valencia, California, United States
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Colorado Springs, Colorado, United States
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Cutler Bay, Florida, United States
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Cutler Bay, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Fayetteville, Georgia, United States
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Lithonia, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Oxon Hill, Maryland, United States
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New Bedford, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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East Orange, New Jersey, United States
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Toms River, New Jersey, United States
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The Bronx, New York, United States
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Valhalla, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Wilmington, North Carolina, United States
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Blue Ash, Ohio, United States
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Dayton, Ohio, United States
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Edmond, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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Milwaukee, Wisconsin, United States
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Bahía Blanca, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Ciudad Capital, , Argentina
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Ciudad de Buenos Aire, , Argentina
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Concepción del Uruguay, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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Godoy Cruz, , Argentina
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La Plata, , Argentina
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La Plata, , Argentina
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Lobos, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Pilar, , Argentina
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Quilmes, , Argentina
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Ramos Mejía, , Argentina
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Rosario, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Adelaide, , Australia
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Clayton, , Australia
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Kozloduy, , Bulgaria
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Montana, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sliven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Velingrad, , Bulgaria
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Vidin, , Bulgaria
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Quillota, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Vitacura, , Chile
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Klenovnik, , Croatia
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Petrinja, , Croatia
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Rijeka, , Croatia
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Split, , Croatia
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Zagreb, , Croatia
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Berlin, , Germany
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Frankfurt, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Marburg, , Germany
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Gödöllő, , Hungary
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Gyula, , Hungary
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Hajdúnánás, , Hungary
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Pécs, , Hungary
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Szombathely, , Hungary
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Bunkyō City, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Himeji, , Japan
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Kawachinagano-shi, , Japan
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Kobe, , Japan
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Kodaira-shi, , Japan
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Koga-shi, , Japan
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Kokubunji-shi, , Japan
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Kyoto, , Japan
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Nakagun, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sagamihara-shi, , Japan
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Sapporo, , Japan
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Setagaya-ku, , Japan
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Shibuya-Ku, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Toshima-ku, , Japan
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Toshima-ku, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Ksawerów, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Ostróda, , Poland
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Poznan, , Poland
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Tarnów, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Brasov, , Romania
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Brasov, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Caracal, , Romania
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Cluj-Napoca, , Romania
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Deva, , Romania
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Iași, , Romania
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Resca, Com. Dobrosloveni, , Romania
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Timișoara, , Romania
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Belgrade, , Serbia
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Belgrade, , Serbia
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Užice, , Serbia
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Valjevo, , Serbia
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Levice, , Slovakia
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Prešov, , Slovakia
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Topoľčany, , Slovakia
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Germiston, , South Africa
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Krugersdorp, , South Africa
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Lenasia, , South Africa
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Incheon, , South Korea
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Jeonju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Benalmádena, , Spain
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Jerez de la Frontera, , Spain
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Laredo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Istanbul, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Vinnytsia, , Ukraine
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Birmingham, , United Kingdom
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Bradford, , United Kingdom
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Cardiff, , United Kingdom
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Chorley, , United Kingdom
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Corby, , United Kingdom
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Cottingham, , United Kingdom
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Glasgow, , United Kingdom
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Harefield, , United Kingdom
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Hexham, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Portsmouth, , United Kingdom
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Reading, , United Kingdom
Countries
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Other Identifiers
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2023-509243-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003338-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7552C00001
Identifier Type: -
Identifier Source: org_study_id
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