CTIS2023-509243-27-00进行中（未招募）1 期
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 - D7552C00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 741
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Lead-in PK Cohort – Recruitment Completed: Provision of signed informed consent prior to any study-specific procedures, Part 1: Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative, Lead-in PK Cohort – Recruitment Completed: Participant is willing and able to follow study procedures and restrictions, Lead-in PK Cohort – Recruitment Completed: Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m2 (inclusive) at Screening (Visit 1), Lead-in PK Cohort – Recruitment Completed: 18 to 55 years of age inclusive at the time of signing the ICF at Screening (Visit 1), Lead-in PK Cohort – Recruitment Completed: Documented evidence of asthma, Part 1: Morning pre-BD FEV1 between = 40% and = 85% predicted at Screening (Visit 1) and Visit 3, Part 1: Documented history of = 1 severe asthma exacerbation within 1 year prior to Screening (Visit 1), Part 1: Treated with low dose 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). (The ICS can be contained within an ICS-LABA fixed dose combination product). -Treatment with additional asthma controller therapies (eg, LAMA) at a stable dose = 3 months prior to Screening (Visit 1) is allowed. Treatment with LTRAs or 5-LO inhibitors is not allowed, Part 1: An ACQ-6 score = 1.5 at Screening (Visit 1) and at Visit 3, Lead-in PK Cohort – Recruitment Completed: Documented asthma diagnosis = 12 months prior to Screening (Visit 1), Part 1: Body weight = 40 kg and BMI < 35 kg/m2, Lead-in PK Cohort – Recruitment Completed: Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria, Part 1: Documented evidence of asthma, Lead-in PK Cohort – Recruitment Completed: Morning pre-BD FEV1 = 40% predicted at Screening (Visit 1) and Visit 2, Lead-in PK Cohort – Recruitment Completed: Treated with low dose 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). (The ICS can be contained within an ICS-LABA fixed dose combination product) -Treatment with additional asthma controller therapies (eg, LAMA) at a stable dose = 3 months prior to Screening (Visit 1) is allowed. Treatment with LTRAs or 5-LO inhibitors is not allowed (see exclusion criteria), Part 1: Participant is willing and able to follow study procedures and restrictions, Part 1: Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF, Part 1: Able and willing to comply with the requirements of the CSP including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at site, and use electronic devices, eg, eCOA device and spirometry, Part 1: At least 80% compliance with usual asthma background medication during run-in period (from Visit 2 to Visit 3) based on the daily asthma ePROs, Part 1: Minimum 80% compliance with daily eCOA assessments. Compliance is defined as completing the daily ePRO questions and PEF measurement at least 80% of the time during the run-in period and during the 14 days preceding Visit 3, Part 1: For female participants, a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Visit 3, Part 1: Documented physician-diagnosed asthma = 12 months prior to Screening (Visit 1), Part 1: Contrace
排除标准
- •A severe asthma exacerbation within 8 weeks of Screening (Visit 1) or within 12 weeks of randomisation (Visit 3), 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 HIV. For the hepatitis B testing (HBsAg, anti-HBs, and anti-HBc), any of the following would exclude the participant from the study: - Participants positive for HBsAg. - Participants positive for anti-HBc, Evidence of active or untreated latent TB: - Positive IGRA, or repeated indeterminate IGRAs, untreated LTBI (unable to be treated for, or declines treatment of LTBI). - Participants newly diagnosed with LTBI at Screening (Visit 1) could be considered for rescreening if they complete a full course of treatment for LTBI in accordance with recommended treatment guidelines prior to rescreening. In this situation, repeat IGRA test is not required after completion of treatment for LTBI. - Participants with an indeterminate IGRA should undergo a repeat test and if still indeterminate may be enrolled only after being treated for LTBI, Abnormal findings identified on physical examination, ECG, or laboratory testing include, but are not limited to: - ALT or AST = 2 × ULN. - TBL = 1.5 × ULN (unless due to Gilbert's disease). - Evidence of chronic liver disease. - Abnormal vital signs, after 5 minutes of supine or sitting rest (confirmed by one controlled measurement), defined as any of the following: o SBP < 80 mmHg or = 150 mmHg. o DBP < 50 mmHg or = 95 mmHg. o Pulse < 45 or > 100 beats per minute. - Signs of pulmonary oedema or volume overload. - Any clinically significant rhythm, conduction, or morphology abnormalities in the ECG including but not limited to QTcF > 450 ms. Please refer to the protocol for the full list of 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, Participants with a significant COVID-19 illness within 6 months of enrolment: - Participants with a diagnosis of COVID-19 pneumonia based on radiological assessment. - Participants with a diagnosis of COVID-19 requiring hospitalization and/or oxygen supplementation therapy, Clinically important pulmonary disease other than asthma eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1 anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis and hyper-eosinophilic syndrome, 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 in the opinion of the investigator and could: - Affect the safety of the participant throughout the study. - Influence the findings of the study or the interpretation. - Impede the participant's ability to complete the entire duration of study, Any clinically significant cardiac disease: - Acute coronary syndrome (acute myocardial infarction, unstable angina) or coronary intervention with percutaneous coronary intervention/coronary artery bypass surgery within 6 months. - Heart failure NYHA II-IV. - Untreated high degree atrioventricular-block (= 3:1
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