Clinical Trials List
Protocol NumberACT18301
Active
2025-01-31 - 2028-01-30
Phase II
Recruiting7
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
-
Trial Applicant
-
Sponsor
Sanofi Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yen Tu 無
- Wen-Chien Cheng 無
- Bing-Ru Wu 無
- 廖偉志 無
- 黃維俊 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chau-Chyun Sheu
Co-Principal Investigator
- 陳家閔 無
- 鄭至宏 無
- 張旭良
- Hung-Ling Huang 無
- 鄭孟軒 無
- 莊政皓 無
- Ming-Ju Tsai 無
- Wei-An Chang
- jong rung Tsai 無
- Inn-Wen Chong 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Asthma
Objectives
The purpose of this study is to evaluate the efficacy, safety, and tolerability of lunsekimig administered by subcutaneous injection (SC) as an add-on therapy in male and female patients with asthma aged 18 to 80 years (inclusive) who are not eligible for biologic therapy and who, at screening (Visit 1), exhibit elevated fractional exhaled nitric oxide (FeNO ≥ 50 ppb) and increased blood eosinophil counts, compared with placebo.
Test Drug
Lunsekimig/ SAR443765
Active Ingredient
Lunsekimig/ SAR443765
Dosage Form
220
Dosage
165 mg/1.1 mL; 2mL/vial
Endpoints
The annualized asthma exacerbation rate (AAER) will be analyzed in the mITT population using a negative binomial regression model. Per the intercurrent events (ICEs) strategy, the response variable will be the total number of adjudication committee–confirmed asthma exacerbations through Week 52. The model will include treatment group (lunsekimig vs placebo), the IVRS/IWRS randomization strata (Part A background therapy, number of asthma exacerbations in the prior 12 months, and region), and the ICS dose level at screening (Visit 1) as covariates. Other prognostic covariates may be added as appropriate. The log of the observation time will be included as an offset.
For each treatment group, the estimated AAER and its two-sided 95% confidence interval (CI) will be derived from the negative binomial model. The relative risk reduction in AAER for lunsekimig versus placebo, with the corresponding two-sided 95% CI and one-sided p-value, will also be reported.
ICEs will be handled using the treatment policy strategy.
For each treatment group, the estimated AAER and its two-sided 95% confidence interval (CI) will be derived from the negative binomial model. The relative risk reduction in AAER for lunsekimig versus placebo, with the corresponding two-sided 95% CI and one-sided p-value, will also be reported.
ICEs will be handled using the treatment policy strategy.
Inclution Criteria
Inclusion Criteria
Age
I 01. At the time of signing the informed consent form, subjects must be between 18 (inclusive) and 80 (inclusive) years of age.
Subject Type and Disease Characteristics
I 02. Subjects must have a physician-diagnosed asthma, classified as mild to moderate according to the Global Initiative for Asthma (GINA) guidelines, for ≥12 months (1).
I 03. Subjects must receive daily asthma treatment, including:
Maintenance therapy for at least 1 month prior to Screening (Visit 1) with an inhaled corticosteroid (ICS) dose of fluticasone propionate <500 μg/day, budesonide <800 μg/day, or an equivalent ICS dose (with or without LABA);
or
For subjects prescribed low-dose budesonide/formoterol only as needed (without maintenance therapy), they must have used a reliever inhaler at least 7 times per week during the month prior to Screening (Visit 1), with a total ICS dose equivalent to budesonide <800 μg/day.
For country-specific requirements in China, refer to Section 10.7.1.
I 04. Subjects must have experienced ≥1 asthma exacerbation within the 12 months prior to Screening (Visit 1) while receiving one of the following treatments:
(1) Maintenance ICS therapy (fluticasone propionate <500 μg/day, budesonide <800 μg/day, or equivalent ICS dose, with or without LABA); or
(2) As-needed low-dose budesonide/formoterol reliever therapy.
An exacerbation is defined as:
Treatment with systemic corticosteroids (oral or non-oral) for ≥3 consecutive days due to asthma worsening;
or
Hospitalization or emergency department visit due to asthma worsening requiring systemic corticosteroids.
For country-specific requirements in China, refer to Section 10.7.1.
I 05. Pre-bronchodilator (BD) FEV₁ at Screening (Visit 1) must be ≥40% of the predicted normal value according to Global Lung Function Initiative (GLI) standards.
I 06. Bronchodilator reversibility at Screening (Visit 1) or based on documented medical history is defined as an increase in FEV₁ of at least 12% and 200 mL, determined as follows (depending on site practice):
a) Maximum change after up to 4 puffs of albuterol/salbutamol or levalbuterol/levosalbutamol (400 μg albuterol metered dose), per ERS/ATS methodology;
or
b) Maximum change after 4, 6, or 8 puffs of albuterol (360, 540, or 720 μg albuterol metered dose), per Severe Asthma Research Program (SARP) methodology;
or
c) Documented positive reversibility test within 5 years prior to Screening (Visit 1), or a positive bronchial provocation test with methacholine, mannitol, histamine, or acetylcholine (according to local standards).
For additional guidance on BD testing, refer to Section 8.2.
I 07. Fractional exhaled nitric oxide (FeNO) concentration ≥50 ppb at Screening (Visit 1) and ≥20 ppb at Baseline (Visit 3).
I 08. Blood eosinophil count ≥300 cells/μL at Screening (Visit 1),
or
Blood eosinophil count ≥150 cells/μL at Screening (Visit 1) and documented ≥300 cells/μL within the previous 12 months.
Body Weight
I 09. Body Mass Index (BMI) between 18.5 and 40 kg/m² (inclusive).
Sexual Activity, Contraception/Barrier Methods, and Pregnancy Testing/Lactation
I 10. All male and female subjects must use contraception methods consistent with local regulations for participants in clinical trials.
a) Male subjects:
Eligible if they agree to comply with the following during the treatment period and for at least 5 months after the last dose of study intervention:
• No sperm donation or cryopreservation.
And one of the following:
Abstain from heterosexual intercourse (if this is their preferred and habitual lifestyle; i.e., long-term and consistent abstinence) and agree to maintain abstinence,
or
Agree to use contraception/barrier methods as follows:
When engaging in sexual intercourse with a woman of childbearing potential (WOCBP) who is not pregnant, use a male condom and an additional highly effective contraceptive method as described in Appendix 4 (Section 10.4: Contraception and Barrier Method Guidance).
b) Female subjects:
Eligible if not pregnant or breastfeeding and meeting at least one of the following:
Is a woman not of childbearing potential (WONCBP), as defined in Appendix 4 (Section 10.4: Contraception and Barrier Method Guidance);
or
Is a WOCBP who agrees to use a highly effective contraceptive method (annual failure rate <1%), preferably user-independent, as described in Appendix 4.
She must agree to comply with contraception and barrier method requirements throughout the treatment period (initiated prior to intervention) and for 5 months after the last dose of investigational medicinal product (IMP), and refrain from donating or cryopreserving oocytes for reproductive purposes during this period.
A highly sensitive pregnancy test for WOCBP must be negative. A serum pregnancy test will be conducted at Screening (Visit 1), and urine pregnancy tests will be performed before each IMP administration at subsequent visits, at early termination, and at the End of Study (EOS), as described in Section 8.3.5.
Informed Consent
I 11. Ability to provide written informed consent as described in Appendix 1, and to comply with the requirements and restrictions in the informed consent form (ICF) and protocol.
In countries where the legal age of adulthood exceeds 18 years, the subject’s Legally Authorized Representative (LAR) must also sign a specific ICF (refer to Section 10.7.3 for country-specific requirements in Germany).
Age
I 01. At the time of signing the informed consent form, subjects must be between 18 (inclusive) and 80 (inclusive) years of age.
Subject Type and Disease Characteristics
I 02. Subjects must have a physician-diagnosed asthma, classified as mild to moderate according to the Global Initiative for Asthma (GINA) guidelines, for ≥12 months (1).
I 03. Subjects must receive daily asthma treatment, including:
Maintenance therapy for at least 1 month prior to Screening (Visit 1) with an inhaled corticosteroid (ICS) dose of fluticasone propionate <500 μg/day, budesonide <800 μg/day, or an equivalent ICS dose (with or without LABA);
or
For subjects prescribed low-dose budesonide/formoterol only as needed (without maintenance therapy), they must have used a reliever inhaler at least 7 times per week during the month prior to Screening (Visit 1), with a total ICS dose equivalent to budesonide <800 μg/day.
For country-specific requirements in China, refer to Section 10.7.1.
I 04. Subjects must have experienced ≥1 asthma exacerbation within the 12 months prior to Screening (Visit 1) while receiving one of the following treatments:
(1) Maintenance ICS therapy (fluticasone propionate <500 μg/day, budesonide <800 μg/day, or equivalent ICS dose, with or without LABA); or
(2) As-needed low-dose budesonide/formoterol reliever therapy.
An exacerbation is defined as:
Treatment with systemic corticosteroids (oral or non-oral) for ≥3 consecutive days due to asthma worsening;
or
Hospitalization or emergency department visit due to asthma worsening requiring systemic corticosteroids.
For country-specific requirements in China, refer to Section 10.7.1.
I 05. Pre-bronchodilator (BD) FEV₁ at Screening (Visit 1) must be ≥40% of the predicted normal value according to Global Lung Function Initiative (GLI) standards.
I 06. Bronchodilator reversibility at Screening (Visit 1) or based on documented medical history is defined as an increase in FEV₁ of at least 12% and 200 mL, determined as follows (depending on site practice):
a) Maximum change after up to 4 puffs of albuterol/salbutamol or levalbuterol/levosalbutamol (400 μg albuterol metered dose), per ERS/ATS methodology;
or
b) Maximum change after 4, 6, or 8 puffs of albuterol (360, 540, or 720 μg albuterol metered dose), per Severe Asthma Research Program (SARP) methodology;
or
c) Documented positive reversibility test within 5 years prior to Screening (Visit 1), or a positive bronchial provocation test with methacholine, mannitol, histamine, or acetylcholine (according to local standards).
For additional guidance on BD testing, refer to Section 8.2.
I 07. Fractional exhaled nitric oxide (FeNO) concentration ≥50 ppb at Screening (Visit 1) and ≥20 ppb at Baseline (Visit 3).
I 08. Blood eosinophil count ≥300 cells/μL at Screening (Visit 1),
or
Blood eosinophil count ≥150 cells/μL at Screening (Visit 1) and documented ≥300 cells/μL within the previous 12 months.
Body Weight
I 09. Body Mass Index (BMI) between 18.5 and 40 kg/m² (inclusive).
Sexual Activity, Contraception/Barrier Methods, and Pregnancy Testing/Lactation
I 10. All male and female subjects must use contraception methods consistent with local regulations for participants in clinical trials.
a) Male subjects:
Eligible if they agree to comply with the following during the treatment period and for at least 5 months after the last dose of study intervention:
• No sperm donation or cryopreservation.
And one of the following:
Abstain from heterosexual intercourse (if this is their preferred and habitual lifestyle; i.e., long-term and consistent abstinence) and agree to maintain abstinence,
or
Agree to use contraception/barrier methods as follows:
When engaging in sexual intercourse with a woman of childbearing potential (WOCBP) who is not pregnant, use a male condom and an additional highly effective contraceptive method as described in Appendix 4 (Section 10.4: Contraception and Barrier Method Guidance).
b) Female subjects:
Eligible if not pregnant or breastfeeding and meeting at least one of the following:
Is a woman not of childbearing potential (WONCBP), as defined in Appendix 4 (Section 10.4: Contraception and Barrier Method Guidance);
or
Is a WOCBP who agrees to use a highly effective contraceptive method (annual failure rate <1%), preferably user-independent, as described in Appendix 4.
She must agree to comply with contraception and barrier method requirements throughout the treatment period (initiated prior to intervention) and for 5 months after the last dose of investigational medicinal product (IMP), and refrain from donating or cryopreserving oocytes for reproductive purposes during this period.
A highly sensitive pregnancy test for WOCBP must be negative. A serum pregnancy test will be conducted at Screening (Visit 1), and urine pregnancy tests will be performed before each IMP administration at subsequent visits, at early termination, and at the End of Study (EOS), as described in Section 8.3.5.
Informed Consent
I 11. Ability to provide written informed consent as described in Appendix 1, and to comply with the requirements and restrictions in the informed consent form (ICF) and protocol.
In countries where the legal age of adulthood exceeds 18 years, the subject’s Legally Authorized Representative (LAR) must also sign a specific ICF (refer to Section 10.7.3 for country-specific requirements in Germany).
Exclusion Criteria
Medical Conditions
E 01. Presence of any other serious pulmonary disease that may impair lung function (e.g., chronic obstructive pulmonary disease [COPD], bronchiectasis, idiopathic pulmonary fibrosis, etc.).
E 02. Current smokers or former smokers who quit within 6 months prior to Screening (Visit 1), or subjects with a smoking history of more than 10 pack-years. Subjects who have regularly used any e-cigarettes and/or cannabis within 6 months prior to Screening.
E 03. Subjects who experienced an asthma exacerbation requiring emergency treatment, hospitalization, or systemic corticosteroid therapy within 1 month prior to Screening (Visit 1) (counted from the day of completing asthma exacerbation treatment).
E 04. Subjects who had an upper or lower respiratory tract infection within 4 weeks prior to Screening (Visit 1).
E 05. In study centers where COVID-19 testing is required by local regulations, subjects with confirmed COVID-19 infection at Screening (Visit 1), during the screening period, or at Baseline (Visit 3) must be excluded. Such subjects may be rescreened 4 weeks after symptom resolution, or, if asymptomatic at the time of initial diagnosis, 4 weeks after the first positive COVID-19 test.
E 06. Known history or suspected current significant immunosuppression, including a history of invasive opportunistic infections or helminth infections (even if resolved), or an abnormal frequency or prolonged duration of recurrent infections.
E 07. Active or chronic helminth infection.
E 08. Any evidence of infection requiring systemic antimicrobial therapy within 2 weeks prior to or during Screening (Visit 1). Significant viral infection (e.g., influenza) occurring within 2 weeks prior to or during Screening, even if not treated with systemic antiviral agents (symptomatic treatment only).
E 09. Subjects with active tuberculosis (TB), latent TB, a history of incomplete TB treatment, suspected extrapulmonary TB, high risk of TB infection (e.g., close contact with an individual with active TB), or BCG vaccination within 12 weeks prior to Screening (Visit 1).
Note: TB testing is mandatory to exclude active or latent TB and must be performed, assessed, and documented per local guidelines. If no local guidelines exist or testing cannot be performed on site, blood samples should be sent to the central laboratory for QuantiFERON® testing.
Subjects with confirmed positive TB test results will be excluded unless all the following criteria are met:
a) Documented completion of chemoprophylaxis for latent TB infection or full treatment of active TB per local standards, and
b) Consultation with a specialist confirming that active TB infection has been excluded or treated, and
c) Approval by the sponsor after review confirming eligibility.
E 10. History of any malignancy (except for basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ that was excised and cured >3 years prior to Baseline [Visit 3]).
E 11. History of solid organ transplantation.
E 12. Positive test result for human immunodeficiency virus (HIV) at Screening (Visit 1).
E 13. Positive findings for hepatitis markers at Screening (Visit 1):
Hepatitis B surface antigen (HBsAg) positive (or indeterminate), or
Hepatitis B core immunoglobulin M antibody (IgM anti-HBc) positive, or
Total hepatitis B core antibody (anti-HBc) positive with confirmed positive hepatitis B virus (HBV) DNA result, or
Hepatitis C virus (HCV) antibody positive with confirmed positive HCV RNA result.
For guidance on interpretation of hepatitis serology, refer to Table 9 in Section 8.3.4.
E 14. Clinically significant laboratory abnormalities at Screening (Visit 1):
a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN);
b) Serum total bilirubin >1.5× ULN (subjects with Gilbert’s syndrome and total bilirubin >1.5× ULN may be included if direct bilirubin <1.5× ULN);
c) Hemoglobin <10 g/100 mL for males, <9 g/100 mL for females;
d) Neutrophil count <1500/μL (<1000/μL for subjects of African descent);
e) Platelet count <100,000/μL;
f) Serum creatinine ≥150 μmol/L.
E 15. Any severe comorbid condition that, in the investigator’s opinion, would interfere with participation in the study, including (but not limited to) hypertension, renal disease, neurological disorders, heart failure, or pulmonary disease.
E 16. History of prescription drug or substance (including alcohol) abuse within 2 years prior to Baseline (Visit 3), considered significant by the investigator.
E 17. Planned elective surgery at any time within 3 months after the last dose of the investigational medicinal product (IMP).
Prior or Concomitant Therapies
E 18. Receipt of anti-IgE monoclonal antibody (mAb) therapy (e.g., omalizumab [Xolair®]) within 130 days prior to Screening (Visit 1), or receipt of any other biologic therapy (including anti–IL-4/IL-4R, IL-5/IL-5R, IL-13, or TSLP agents) or systemic immunosuppressants (e.g., methotrexate) within 2 months or 5 half-lives (whichever is longer) prior to Screening, used for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis).
E 19. Prior bronchial thermoplasty.
E 20. Treatment with long-acting muscarinic antagonist (LAMA) inhalers or other controller medications in addition to ICS/LABA prior to Screening (Visit 1).
E 21. Receipt of a live (attenuated) vaccine within 12 weeks prior to Baseline (Visit 3), or planned receipt of any live vaccine during the study. Receipt of any inactivated vaccine within 2 weeks prior to Baseline (Visit 3).
E 22. History of hypersensitivity or allergy to the IMP, any excipients used in its manufacture, or any components of its administration preparation, or other allergies deemed by the investigator to preclude study participation.
Prior or Concurrent Clinical Trial Participation
E 23. Participation in an investigational therapy for asthma or other conditions within 5 half-lives of the previous investigational product, or within 3 months if the half-life is unknown, or within the pharmacodynamic (PD) activity period.
E 24. Current participation in any other clinical trial, including non-interventional studies.
Other Exclusion Criteria
E 25. Non-compliance with ICS/LABA treatment during Part A run-in period, defined as:
Use of prescribed inhaler less than 70% of total expected doses (<70%), as assessed by eDiary review or investigator/site staff evaluation.
E 26. Individuals who are institutionalized by regulatory or legal order; prisoners or individuals involuntarily detained.
E 27. Subjects deemed unsuitable for study participation by the investigator, for any reason, including medical or clinical conditions or potential non-compliance with study procedures.
E 28. Employees of the clinical trial site, or other individuals directly involved in trial conduct, or their immediate family members (refer to ICH-GCP E6 Section 1.61).
E 29. History of hypersensitivity to any investigational product or its components, or previous drug or other allergies that, in the investigator’s opinion, preclude study participation.
E 30. Subjects who cannot participate in the study due to country-specific regulatory restrictions — see Appendix 8 (Country-Specific Requirements).
For country-specific requirements in France, refer to Section 10.7.4.
E 01. Presence of any other serious pulmonary disease that may impair lung function (e.g., chronic obstructive pulmonary disease [COPD], bronchiectasis, idiopathic pulmonary fibrosis, etc.).
E 02. Current smokers or former smokers who quit within 6 months prior to Screening (Visit 1), or subjects with a smoking history of more than 10 pack-years. Subjects who have regularly used any e-cigarettes and/or cannabis within 6 months prior to Screening.
E 03. Subjects who experienced an asthma exacerbation requiring emergency treatment, hospitalization, or systemic corticosteroid therapy within 1 month prior to Screening (Visit 1) (counted from the day of completing asthma exacerbation treatment).
E 04. Subjects who had an upper or lower respiratory tract infection within 4 weeks prior to Screening (Visit 1).
E 05. In study centers where COVID-19 testing is required by local regulations, subjects with confirmed COVID-19 infection at Screening (Visit 1), during the screening period, or at Baseline (Visit 3) must be excluded. Such subjects may be rescreened 4 weeks after symptom resolution, or, if asymptomatic at the time of initial diagnosis, 4 weeks after the first positive COVID-19 test.
E 06. Known history or suspected current significant immunosuppression, including a history of invasive opportunistic infections or helminth infections (even if resolved), or an abnormal frequency or prolonged duration of recurrent infections.
E 07. Active or chronic helminth infection.
E 08. Any evidence of infection requiring systemic antimicrobial therapy within 2 weeks prior to or during Screening (Visit 1). Significant viral infection (e.g., influenza) occurring within 2 weeks prior to or during Screening, even if not treated with systemic antiviral agents (symptomatic treatment only).
E 09. Subjects with active tuberculosis (TB), latent TB, a history of incomplete TB treatment, suspected extrapulmonary TB, high risk of TB infection (e.g., close contact with an individual with active TB), or BCG vaccination within 12 weeks prior to Screening (Visit 1).
Note: TB testing is mandatory to exclude active or latent TB and must be performed, assessed, and documented per local guidelines. If no local guidelines exist or testing cannot be performed on site, blood samples should be sent to the central laboratory for QuantiFERON® testing.
Subjects with confirmed positive TB test results will be excluded unless all the following criteria are met:
a) Documented completion of chemoprophylaxis for latent TB infection or full treatment of active TB per local standards, and
b) Consultation with a specialist confirming that active TB infection has been excluded or treated, and
c) Approval by the sponsor after review confirming eligibility.
E 10. History of any malignancy (except for basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ that was excised and cured >3 years prior to Baseline [Visit 3]).
E 11. History of solid organ transplantation.
E 12. Positive test result for human immunodeficiency virus (HIV) at Screening (Visit 1).
E 13. Positive findings for hepatitis markers at Screening (Visit 1):
Hepatitis B surface antigen (HBsAg) positive (or indeterminate), or
Hepatitis B core immunoglobulin M antibody (IgM anti-HBc) positive, or
Total hepatitis B core antibody (anti-HBc) positive with confirmed positive hepatitis B virus (HBV) DNA result, or
Hepatitis C virus (HCV) antibody positive with confirmed positive HCV RNA result.
For guidance on interpretation of hepatitis serology, refer to Table 9 in Section 8.3.4.
E 14. Clinically significant laboratory abnormalities at Screening (Visit 1):
a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN);
b) Serum total bilirubin >1.5× ULN (subjects with Gilbert’s syndrome and total bilirubin >1.5× ULN may be included if direct bilirubin <1.5× ULN);
c) Hemoglobin <10 g/100 mL for males, <9 g/100 mL for females;
d) Neutrophil count <1500/μL (<1000/μL for subjects of African descent);
e) Platelet count <100,000/μL;
f) Serum creatinine ≥150 μmol/L.
E 15. Any severe comorbid condition that, in the investigator’s opinion, would interfere with participation in the study, including (but not limited to) hypertension, renal disease, neurological disorders, heart failure, or pulmonary disease.
E 16. History of prescription drug or substance (including alcohol) abuse within 2 years prior to Baseline (Visit 3), considered significant by the investigator.
E 17. Planned elective surgery at any time within 3 months after the last dose of the investigational medicinal product (IMP).
Prior or Concomitant Therapies
E 18. Receipt of anti-IgE monoclonal antibody (mAb) therapy (e.g., omalizumab [Xolair®]) within 130 days prior to Screening (Visit 1), or receipt of any other biologic therapy (including anti–IL-4/IL-4R, IL-5/IL-5R, IL-13, or TSLP agents) or systemic immunosuppressants (e.g., methotrexate) within 2 months or 5 half-lives (whichever is longer) prior to Screening, used for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis).
E 19. Prior bronchial thermoplasty.
E 20. Treatment with long-acting muscarinic antagonist (LAMA) inhalers or other controller medications in addition to ICS/LABA prior to Screening (Visit 1).
E 21. Receipt of a live (attenuated) vaccine within 12 weeks prior to Baseline (Visit 3), or planned receipt of any live vaccine during the study. Receipt of any inactivated vaccine within 2 weeks prior to Baseline (Visit 3).
E 22. History of hypersensitivity or allergy to the IMP, any excipients used in its manufacture, or any components of its administration preparation, or other allergies deemed by the investigator to preclude study participation.
Prior or Concurrent Clinical Trial Participation
E 23. Participation in an investigational therapy for asthma or other conditions within 5 half-lives of the previous investigational product, or within 3 months if the half-life is unknown, or within the pharmacodynamic (PD) activity period.
E 24. Current participation in any other clinical trial, including non-interventional studies.
Other Exclusion Criteria
E 25. Non-compliance with ICS/LABA treatment during Part A run-in period, defined as:
Use of prescribed inhaler less than 70% of total expected doses (<70%), as assessed by eDiary review or investigator/site staff evaluation.
E 26. Individuals who are institutionalized by regulatory or legal order; prisoners or individuals involuntarily detained.
E 27. Subjects deemed unsuitable for study participation by the investigator, for any reason, including medical or clinical conditions or potential non-compliance with study procedures.
E 28. Employees of the clinical trial site, or other individuals directly involved in trial conduct, or their immediate family members (refer to ICH-GCP E6 Section 1.61).
E 29. History of hypersensitivity to any investigational product or its components, or previous drug or other allergies that, in the investigator’s opinion, preclude study participation.
E 30. Subjects who cannot participate in the study due to country-specific regulatory restrictions — see Appendix 8 (Country-Specific Requirements).
For country-specific requirements in France, refer to Section 10.7.4.
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
430 participants
