Clinical Trials List
Protocol NumberGB-0895-301
Not yet recruiting
2025-12-11 - 2031-06-30
Phase III
Recruiting6
A phase 3, randomized, double-blind, placebo-controlled trial was conducted to evaluate the efficacy and safety of GB-0895 adjunctive therapy in adults and adolescents with severe, poorly controlled asthma.
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Sponsor
Hong Kong-based Fama Succic Product Development Co., Ltd. Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen Chia-Hung 無
- 廖偉志 無
- Wen-Chien Cheng 無
- 陳傑龍 無
- 黃維俊 無
- 蘇育嬅 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- jong rung Tsai 無
- Inn-Wen Chong 無
- Wei-An Chang 無
- 鄭孟軒 無
- Ming-Ju Tsai 無
- 陳家閔 無
- 鄭至宏 無
- Hung-Ling Huang 無
- 莊政皓 無
- 李岱晃 無
- 張旭良 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Horng-Chyuan Lin
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Adults and adolescents with severely uncontrolled asthma
Objectives
Double-blind trial
Primary objective: To evaluate the efficacy of GB-0895 (300 mg subcutaneous [SC] every 26 weeks) as adjunctive therapy compared to placebo in adults and adolescents with severely poorly controlled asthma, in reducing clinically significant asthma exacerbations over 52 weeks.
Key secondary objectives:
• To evaluate the efficacy of GB-0895 (300 mg SC every 26 weeks) as adjunctive therapy compared to placebo in subjects with a baseline eosinophil count (EOS) <300 cells/µL, in reducing clinically significant asthma exacerbations over 52 weeks.
• To evaluate the efficacy of GB-0895 compared to placebo in terms of lung function, health-related quality of life (HRQoL), and asthma control.
Safety objective: To investigate the safety profile of GB-0895.
Open-label extended period
Safety objective: To evaluate GB-0895 300 mg SC Q6M Security features in Open-Label Extension (OLE)
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Test Drug
GB-0895
Active Ingredient
GB-0895
Dosage Form
Dosage
150 mg/mL (300 mg/vial)
Endpoints
• The annualized asthma exacerbation rate (AAER) with clinically significant exacerbations during the 52-week period is defined as an exacerbation requiring treatment with systemic corticosteroids (oral, intravenous, or intramuscular) and/or a hospitalization or emergency room visit requiring treatment with systemic corticosteroids.
Inclution Criteria
To be eligible for this trial, each participant must meet all of the following criteria:
1. Be able to sign a participant consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations outlined in this trial protocol.
2. Be an adult or adolescent aged ≥12 years and ≤80 years at the time of signing the participant consent form.
a. The number of adolescents <18 years of age will be limited to approximately 10% of the total enrollment.
b. For countries where local regulations or investigational drug regulations only permit adult enrollment, participants aged ≥18 years (or as per local legal age) and ≤80 years (or as required by local regulations) will be recruited.
3. There must be a record showing that the participant has been diagnosed with asthma for ≥2 years according to the National Heart, Lung, Blood Institute guidelines or the Global Initiative for Asthma (GINA) guidelines.
4. Documented records show that prior to the first screening follow-up visit, the physician instructed the subject to receive moderate to high doses of ICS (inhaled corticosteroids) daily for ≥12 months, and to use at least one additional control medication (e.g., LABA [long-acting beta-agonist], LAMA [long-acting anticholinergic]) for ≥3 months prior to the first screening follow-up visit, with the ICS or control medication remaining unchanged for at least 3 months.
Note: Subjects using ICS-formoterol as maintenance and remission therapy must have received this treatment for ≥12 months prior to the first screening follow-up visit, and the ICS dose must have remained unchanged for at least 3 months.
5. The classification of moderate and high dose ICS should follow the definitions described in the GINA guidelines.
a. Subjects receiving moderate-dose ICS will also need to receive LABA treatment to be eligible for inclusion.
6. Subjects using intermediate to high doses of ICS within 12 months prior to their first screening follow-up visit must also have a history of at least two asthma exacerbations requiring systemic corticosteroid (ICS) treatment. These include: Asthma exacerbation is defined as:
a. An asthma exacerbation requiring at least 3 consecutive days of ICS treatment (a single dose of long-acting injectable corticosteroid is considered equivalent to a 3-day ICS treatment course).
Or
b. An emergency room visit requiring ICS treatment (IV, IM, or oral) for asthma (as described above) (defined as assessment and treatment in the emergency room or emergency care center for <24 hours).
Or
c. Hospitalization due to asthma (defined as admission to an inpatient facility and/or assessment and treatment in a medical facility for ≥24 hours).
Note: For subjects receiving a stable maintenance dose of OCS (oral corticosteroids), a temporary increase to at least twice the current stable maintenance dose for at least 3 consecutive days qualifies as an exacerbation.
Note: Subjects using a stable (≥3 months) asthma maintenance medication dose within the 6 weeks prior to screening may be included if, according to the trial administrator's judgment, they meet the following criteria: 1) their current pre-exacerbation asthma treatment has stabilized their asthma condition, and 2) they are fit for the 52-week trial and have no plans to change their asthma maintenance medication.
Note: Asthma history records include:
• A discharge summary from a hospital, emergency room, or emergency care center showing that the subject was hospitalized and/or received systemic steroid treatment due to asthma exacerbation.
• A record signed and dated by the referring physician, including information on the diagnosis and use of systemic steroids to treat asthma exacerbation.
• Evidence provided by the subject of systemic steroid prescriptions used during asthma exacerbations.
• Timely recording of conversations between the trial administrator/nurse or specialist nurse and participants enrolled in the OCS Action Plan, detailing the diagnosis and treatment of asthma exacerbations.
• Recording of conversations between the attending/referring physician or nurse/specialist nurse demonstrating asthma exacerbation in their clinic or under their supervision, using steroid treatment. The date of the exacerbation (year/month) and verbal confirmation that an appropriate prescription was provided must be stated. This option should only be used if obtaining a record from the participant by reasonable means fails.
7. The following symptoms indicate airflow obstruction:
a. For adults ≥18 years of age at the first screening follow-up, a forced expiratory volume in 1 second (FEV1) recorded at the first screening follow-up <80% of the predicted value (Global Lung Initiative 12, GLI 12*).
b. For adolescents aged 12 to <18 years at the first screening follow-up:
i. FEV1 before BD recorded at the first screening follow-up is <90% of the predicted value (GLI 12*)
or
ii. FEV1:Forced Vital Capacity (FVC) ratio recorded at the first screening follow-up is <0.80
*In areas where the GLI 12 criteria are not used, other reference ranges may be used.
8. Positive BD response test: An increase in FEV1 of at least 12% and 200 mL (according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines) between 15 and 60 minutes after at least one SABA (rapid-acting beta-gamma sympathetic agonist) administration during screening. Note: If a subject's BD response test is negative, the test may be repeated during screening, provided that the subject experiences an increase in FEV1 ≥9% between 15 and 60 minutes after SABA administration.
Or
Sufficient evidence shows a positive BD response test result ≤18 months prior to the screening follow-up visit.
9. Asthma Control Questionnaire (ACQ-6) score ≥1.5 at the screening follow-up visit.
10. Weight ≥40 kg at the first screening follow-up visit.
11. Women of Childbearing Potential (WOCBP) must have a negative high-sensitivity serum pregnancy test at the first screening follow-up visit, and a negative high-sensitivity urine pregnancy test within 24 hours prior to the first dose of trial treatment.
12. Non-fertile female subjects are eligible to participate. Female participants in WOCBP trials, or male participants with WOCBP partners, must agree to use a highly effective contraceptive method (failure rate <1%) from at least 14 days before the first dose of trial treatment until at least 15 months after the last dose of trial treatment to be eligible for participation. The contraceptive method should comply with local regulations regarding contraceptive methods for clinical trial participants.
Note: The trial administrator should assess the likelihood of contraceptive failure (e.g., non-compliance, initiation of contraception too close to the first dose of trial treatment).
Note: The trial administrator is responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of including women with undetected early pregnancies.
Note: If fertility changes after the start of the trial (e.g., a premenopausal female participant experiences menarche) or pregnancy risk changes (e.g., a female participant who has never had heterosexual intercourse begins heterosexual intercourse), the participant must discuss this with the trial administrator, who should determine whether the female participant must begin using a highly effective contraceptive method. Additional evaluation should be considered if there are concerns about reproductive status.
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1. Be able to sign a participant consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations outlined in this trial protocol.
2. Be an adult or adolescent aged ≥12 years and ≤80 years at the time of signing the participant consent form.
a. The number of adolescents <18 years of age will be limited to approximately 10% of the total enrollment.
b. For countries where local regulations or investigational drug regulations only permit adult enrollment, participants aged ≥18 years (or as per local legal age) and ≤80 years (or as required by local regulations) will be recruited.
3. There must be a record showing that the participant has been diagnosed with asthma for ≥2 years according to the National Heart, Lung, Blood Institute guidelines or the Global Initiative for Asthma (GINA) guidelines.
4. Documented records show that prior to the first screening follow-up visit, the physician instructed the subject to receive moderate to high doses of ICS (inhaled corticosteroids) daily for ≥12 months, and to use at least one additional control medication (e.g., LABA [long-acting beta-agonist], LAMA [long-acting anticholinergic]) for ≥3 months prior to the first screening follow-up visit, with the ICS or control medication remaining unchanged for at least 3 months.
Note: Subjects using ICS-formoterol as maintenance and remission therapy must have received this treatment for ≥12 months prior to the first screening follow-up visit, and the ICS dose must have remained unchanged for at least 3 months.
5. The classification of moderate and high dose ICS should follow the definitions described in the GINA guidelines.
a. Subjects receiving moderate-dose ICS will also need to receive LABA treatment to be eligible for inclusion.
6. Subjects using intermediate to high doses of ICS within 12 months prior to their first screening follow-up visit must also have a history of at least two asthma exacerbations requiring systemic corticosteroid (ICS) treatment. These include: Asthma exacerbation is defined as:
a. An asthma exacerbation requiring at least 3 consecutive days of ICS treatment (a single dose of long-acting injectable corticosteroid is considered equivalent to a 3-day ICS treatment course).
Or
b. An emergency room visit requiring ICS treatment (IV, IM, or oral) for asthma (as described above) (defined as assessment and treatment in the emergency room or emergency care center for <24 hours).
Or
c. Hospitalization due to asthma (defined as admission to an inpatient facility and/or assessment and treatment in a medical facility for ≥24 hours).
Note: For subjects receiving a stable maintenance dose of OCS (oral corticosteroids), a temporary increase to at least twice the current stable maintenance dose for at least 3 consecutive days qualifies as an exacerbation.
Note: Subjects using a stable (≥3 months) asthma maintenance medication dose within the 6 weeks prior to screening may be included if, according to the trial administrator's judgment, they meet the following criteria: 1) their current pre-exacerbation asthma treatment has stabilized their asthma condition, and 2) they are fit for the 52-week trial and have no plans to change their asthma maintenance medication.
Note: Asthma history records include:
• A discharge summary from a hospital, emergency room, or emergency care center showing that the subject was hospitalized and/or received systemic steroid treatment due to asthma exacerbation.
• A record signed and dated by the referring physician, including information on the diagnosis and use of systemic steroids to treat asthma exacerbation.
• Evidence provided by the subject of systemic steroid prescriptions used during asthma exacerbations.
• Timely recording of conversations between the trial administrator/nurse or specialist nurse and participants enrolled in the OCS Action Plan, detailing the diagnosis and treatment of asthma exacerbations.
• Recording of conversations between the attending/referring physician or nurse/specialist nurse demonstrating asthma exacerbation in their clinic or under their supervision, using steroid treatment. The date of the exacerbation (year/month) and verbal confirmation that an appropriate prescription was provided must be stated. This option should only be used if obtaining a record from the participant by reasonable means fails.
7. The following symptoms indicate airflow obstruction:
a. For adults ≥18 years of age at the first screening follow-up, a forced expiratory volume in 1 second (FEV1) recorded at the first screening follow-up <80% of the predicted value (Global Lung Initiative 12, GLI 12*).
b. For adolescents aged 12 to <18 years at the first screening follow-up:
i. FEV1 before BD recorded at the first screening follow-up is <90% of the predicted value (GLI 12*)
or
ii. FEV1:Forced Vital Capacity (FVC) ratio recorded at the first screening follow-up is <0.80
*In areas where the GLI 12 criteria are not used, other reference ranges may be used.
8. Positive BD response test: An increase in FEV1 of at least 12% and 200 mL (according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines) between 15 and 60 minutes after at least one SABA (rapid-acting beta-gamma sympathetic agonist) administration during screening. Note: If a subject's BD response test is negative, the test may be repeated during screening, provided that the subject experiences an increase in FEV1 ≥9% between 15 and 60 minutes after SABA administration.
Or
Sufficient evidence shows a positive BD response test result ≤18 months prior to the screening follow-up visit.
9. Asthma Control Questionnaire (ACQ-6) score ≥1.5 at the screening follow-up visit.
10. Weight ≥40 kg at the first screening follow-up visit.
11. Women of Childbearing Potential (WOCBP) must have a negative high-sensitivity serum pregnancy test at the first screening follow-up visit, and a negative high-sensitivity urine pregnancy test within 24 hours prior to the first dose of trial treatment.
12. Non-fertile female subjects are eligible to participate. Female participants in WOCBP trials, or male participants with WOCBP partners, must agree to use a highly effective contraceptive method (failure rate <1%) from at least 14 days before the first dose of trial treatment until at least 15 months after the last dose of trial treatment to be eligible for participation. The contraceptive method should comply with local regulations regarding contraceptive methods for clinical trial participants.
Note: The trial administrator should assess the likelihood of contraceptive failure (e.g., non-compliance, initiation of contraception too close to the first dose of trial treatment).
Note: The trial administrator is responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of including women with undetected early pregnancies.
Note: If fertility changes after the start of the trial (e.g., a premenopausal female participant experiences menarche) or pregnancy risk changes (e.g., a female participant who has never had heterosexual intercourse begins heterosexual intercourse), the participant must discuss this with the trial administrator, who should determine whether the female participant must begin using a highly effective contraceptive method. Additional evaluation should be considered if there are concerns about reproductive status.
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Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from this trial:
1. Subjects experiencing a clinically significant exacerbation of asthma within 12 weeks prior to the screening follow-up visit or during the lead-up period, requiring a change in asthma maintenance therapy, will not be included.
2. Concurrent respiratory illness: In addition to asthma, subjects with a clinically significant known pre-existing lung disease. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, or a history of diagnosis of chronic obstructive pulmonary disease (including but not limited to emphysema and/or chronic bronchitis) or lung cancer. Note: Subjects with known or suspected active tuberculosis (pulmonary or extrapulmonary) are not eligible to participate in the trial. TB (tuberculosis) screening is not required in the trial protocol, but may be performed according to local regulations, guidelines, or the trial administrator's judgment. Subjects with a history of latent or active TB treatment are eligible, provided there is no evidence of active disease and the subject has successfully completed treatment for at least 12 months prior to the first dose of medication. 3. Eosinophilic Leukemia Disorders: Subjects with other conditions that may lead to elevated EOS (eosinophil counts), such as eosinophilic leukocytosis, including (but not limited to) eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss syndrome) or eosinophilic esophagitis.
4. Any disease, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physical injury, that the trial administrator deems to be unstable and likely to:
a. affect the safety of the subject during the trial.
b. affect the findings or interpretation of the trial.
c. prevent the subject from completing the entire trial period.
5. The occurrence of a clinically significant infection requiring treatment with systemic antibiotics, antifungal, antiparasitic, or antiviral drugs within 14 days prior to enrollment or during the induction period.
6. The occurrence of a clinically significant, acute, unresolved illness within 7 days prior to randomization (Day 1). Note: Randomization may be delayed for full recovery if the trial administrator agrees.
7. Malignant Tumors: Subjects currently suffering from malignant tumors or with a history of cancer within the past 5 years (subjects with localized skin cancer or surgically removed cervical carcinoma in situ are not excluded).
8. Helminthiasis: Subjects with a known pre-existing helminthiasis within the 6 months prior to the first screening follow-up visit.
9. Current smokers or those with a history of smoking (≥10 pack-years), and subjects using vaping products (including e-cigarettes). Past smokers with a smoking history of <10 pack-years, or those who have used vaping products or e-cigarettes, must have stopped using them for at least 6 months prior to the first screening follow-up visit to be eligible.
10. Known history of immunodeficiency, including a positive Human Immunodeficiency Virus (HIV) test at the first screening follow-up, or confirmation from medical history and/or verbal statements that the subject is currently using antiretroviral drugs.
11. Underwent major surgery or is scheduled for surgery requiring general anesthesia within 8 weeks prior to the first screening follow-up, or requires hospitalization for >1 day during the trial.
12. Used any anti-IL (interleukin)-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months prior to the first screening follow-up, or previously used other monoclonal antibodies for asthma treatment (e.g., dupilimab, omalizumab) within 4 months or 5 half-lives (whichever is longer) within 4 months or 5 half-lives prior to the first screening follow-up.
13. Prior (at any time) use of any anti-TSLP (thymic stromal lymphopoietin) or anti-TSLP receptor biologic, whether approved (e.g., tezepelumab) or investigational drug.
14. Treatment with the following medications within 12 weeks prior to randomization: systemic immunosuppressive/immunomodulatory drugs (e.g., methotrexate, cyclosporine), excluding OCS used to treat asthma/asthma exacerbations. Asthma may be treated with maintenance OCS prednisone ≤10 mg/day (or equivalent) if the dose has remained stable for ≥3 months prior to screening and no discontinuation or change is planned during the 52-week trial treatment period.
15. Received an investigational biologic within 4 months or 5 half-lives prior to the first screening follow-up, or an investigational non-biologic within 30 days or 5 half-lives prior to the first screening follow-up.
16. A history of allergy to any component of the investigational treatment, or a history of drug allergy or other allergic reactions, deemed unsuitable for participation by the trial administrator or medical monitor.
17. A history of life-threatening anaphylactic shock following any biological therapy.
18. Concurrent enrollment in another clinical trial involving IP (investigational drug).
19. The subject has been randomized in the current trial or a previous GB-0895 trial.
20. Those involved in the planning and/or execution of the trial (applicable to Generate or PPD personnel and/or trial center personnel), or the subject themselves are employed by the trial center or the trial sponsor, or are relatives of employees of the trial center or the trial sponsor.
21. Any clinically significant abnormalities found in physical examination, vital signs, electrocardiogram (ECG), hematology, serological chemistry, or urinalysis, deemed by the trial administrator to potentially put the subject at risk due to participation in the trial, or to potentially affect the trial results or the subject's ability to complete the entire trial period.
22. Cirrhosis (with or without evidence of liver dysfunction) or other active or clinically significant liver disease (including aspartate transaminase, alanine transaminase, or alkaline phosphatase >2 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN) will be excluded. Subjects with total bilirubin >1.5 times the ULN and accompanied by Gilbert's syndrome (isolated unconjugated hyperbilirubinemia) are permitted inclusion if no other liver abnormalities are present.
23. Hepatitis B or Hepatitis C:
i. Hepatitis B virus (HBV) screening includes HBV surface antigen (HBsAg), HBV surface antibody (anti-HBs), and total HBV core antibody (anti-HBc total). If the hepatitis B surface antigen (HBsAg) is positive, exclusion is granted. Subjects with a positive anti-HBc-total test but a negative anti-HBs test must undergo further HBV DNA testing. Subjects with detected HBV DNA, those for whom the test cannot be performed, or those with evidence of chronic liver disease will be excluded.
ii. Subjects with chronic hepatitis C virus (HCV) infection will be excluded. Subjects with prior HCV infection (HCV antibody positive) and undetectable recorded viral load (HCV RNA) may be included, provided there is evidence of two undetectable HCV RNA tests (at least 12 weeks apart), one of which can be the test performed at screening.
24. Received immunoglobulin or blood products within 30 days prior to the first screening follow-up visit.
25. Received an active attenuated vaccine within 30 days prior to randomization and during the trial period (including the follow-up period).
26. Received the T2 cytokine inhibitor Suplatast tosilate within 15 days prior to the first screening follow-up.
27. Underwent bronchoplastic surgery within 12 months prior to the first screening follow-up.
28. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial are ineligible for the trial.
29. Subjects deemed unwilling or unable to follow the trial procedures by the trial administrator, including poor adherence to asthma control medications.
30. A history of (or suspected history of) alcohol or drug abuse within 2 years prior to the first screening follow-up.
1. Subjects experiencing a clinically significant exacerbation of asthma within 12 weeks prior to the screening follow-up visit or during the lead-up period, requiring a change in asthma maintenance therapy, will not be included.
2. Concurrent respiratory illness: In addition to asthma, subjects with a clinically significant known pre-existing lung disease. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, or a history of diagnosis of chronic obstructive pulmonary disease (including but not limited to emphysema and/or chronic bronchitis) or lung cancer. Note: Subjects with known or suspected active tuberculosis (pulmonary or extrapulmonary) are not eligible to participate in the trial. TB (tuberculosis) screening is not required in the trial protocol, but may be performed according to local regulations, guidelines, or the trial administrator's judgment. Subjects with a history of latent or active TB treatment are eligible, provided there is no evidence of active disease and the subject has successfully completed treatment for at least 12 months prior to the first dose of medication. 3. Eosinophilic Leukemia Disorders: Subjects with other conditions that may lead to elevated EOS (eosinophil counts), such as eosinophilic leukocytosis, including (but not limited to) eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss syndrome) or eosinophilic esophagitis.
4. Any disease, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physical injury, that the trial administrator deems to be unstable and likely to:
a. affect the safety of the subject during the trial.
b. affect the findings or interpretation of the trial.
c. prevent the subject from completing the entire trial period.
5. The occurrence of a clinically significant infection requiring treatment with systemic antibiotics, antifungal, antiparasitic, or antiviral drugs within 14 days prior to enrollment or during the induction period.
6. The occurrence of a clinically significant, acute, unresolved illness within 7 days prior to randomization (Day 1). Note: Randomization may be delayed for full recovery if the trial administrator agrees.
7. Malignant Tumors: Subjects currently suffering from malignant tumors or with a history of cancer within the past 5 years (subjects with localized skin cancer or surgically removed cervical carcinoma in situ are not excluded).
8. Helminthiasis: Subjects with a known pre-existing helminthiasis within the 6 months prior to the first screening follow-up visit.
9. Current smokers or those with a history of smoking (≥10 pack-years), and subjects using vaping products (including e-cigarettes). Past smokers with a smoking history of <10 pack-years, or those who have used vaping products or e-cigarettes, must have stopped using them for at least 6 months prior to the first screening follow-up visit to be eligible.
10. Known history of immunodeficiency, including a positive Human Immunodeficiency Virus (HIV) test at the first screening follow-up, or confirmation from medical history and/or verbal statements that the subject is currently using antiretroviral drugs.
11. Underwent major surgery or is scheduled for surgery requiring general anesthesia within 8 weeks prior to the first screening follow-up, or requires hospitalization for >1 day during the trial.
12. Used any anti-IL (interleukin)-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months prior to the first screening follow-up, or previously used other monoclonal antibodies for asthma treatment (e.g., dupilimab, omalizumab) within 4 months or 5 half-lives (whichever is longer) within 4 months or 5 half-lives prior to the first screening follow-up.
13. Prior (at any time) use of any anti-TSLP (thymic stromal lymphopoietin) or anti-TSLP receptor biologic, whether approved (e.g., tezepelumab) or investigational drug.
14. Treatment with the following medications within 12 weeks prior to randomization: systemic immunosuppressive/immunomodulatory drugs (e.g., methotrexate, cyclosporine), excluding OCS used to treat asthma/asthma exacerbations. Asthma may be treated with maintenance OCS prednisone ≤10 mg/day (or equivalent) if the dose has remained stable for ≥3 months prior to screening and no discontinuation or change is planned during the 52-week trial treatment period.
15. Received an investigational biologic within 4 months or 5 half-lives prior to the first screening follow-up, or an investigational non-biologic within 30 days or 5 half-lives prior to the first screening follow-up.
16. A history of allergy to any component of the investigational treatment, or a history of drug allergy or other allergic reactions, deemed unsuitable for participation by the trial administrator or medical monitor.
17. A history of life-threatening anaphylactic shock following any biological therapy.
18. Concurrent enrollment in another clinical trial involving IP (investigational drug).
19. The subject has been randomized in the current trial or a previous GB-0895 trial.
20. Those involved in the planning and/or execution of the trial (applicable to Generate or PPD personnel and/or trial center personnel), or the subject themselves are employed by the trial center or the trial sponsor, or are relatives of employees of the trial center or the trial sponsor.
21. Any clinically significant abnormalities found in physical examination, vital signs, electrocardiogram (ECG), hematology, serological chemistry, or urinalysis, deemed by the trial administrator to potentially put the subject at risk due to participation in the trial, or to potentially affect the trial results or the subject's ability to complete the entire trial period.
22. Cirrhosis (with or without evidence of liver dysfunction) or other active or clinically significant liver disease (including aspartate transaminase, alanine transaminase, or alkaline phosphatase >2 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN) will be excluded. Subjects with total bilirubin >1.5 times the ULN and accompanied by Gilbert's syndrome (isolated unconjugated hyperbilirubinemia) are permitted inclusion if no other liver abnormalities are present.
23. Hepatitis B or Hepatitis C:
i. Hepatitis B virus (HBV) screening includes HBV surface antigen (HBsAg), HBV surface antibody (anti-HBs), and total HBV core antibody (anti-HBc total). If the hepatitis B surface antigen (HBsAg) is positive, exclusion is granted. Subjects with a positive anti-HBc-total test but a negative anti-HBs test must undergo further HBV DNA testing. Subjects with detected HBV DNA, those for whom the test cannot be performed, or those with evidence of chronic liver disease will be excluded.
ii. Subjects with chronic hepatitis C virus (HCV) infection will be excluded. Subjects with prior HCV infection (HCV antibody positive) and undetectable recorded viral load (HCV RNA) may be included, provided there is evidence of two undetectable HCV RNA tests (at least 12 weeks apart), one of which can be the test performed at screening.
24. Received immunoglobulin or blood products within 30 days prior to the first screening follow-up visit.
25. Received an active attenuated vaccine within 30 days prior to randomization and during the trial period (including the follow-up period).
26. Received the T2 cytokine inhibitor Suplatast tosilate within 15 days prior to the first screening follow-up.
27. Underwent bronchoplastic surgery within 12 months prior to the first screening follow-up.
28. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial are ineligible for the trial.
29. Subjects deemed unwilling or unable to follow the trial procedures by the trial administrator, including poor adherence to asthma control medications.
30. A history of (or suspected history of) alcohol or drug abuse within 2 years prior to the first screening follow-up.
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
786 participants
