A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma
Overview
- Phase
- Phase 2
- Intervention
- FB825
- Conditions
- Allergic Asthma
- Sponsor
- Oneness Biotech Co., Ltd.
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- Occurrence of an exacerbation of asthma at week 24 after first dosing.
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.
Detailed Description
The study comprises of a 4-week screening period, a 24-week treatment period and a 12-week follow-up period. It is anticipated that approximately 100 subjects will be enrolled into this trial, in order to complete a total of 92 evaluable subjects. Eligible subjects will be randomized to receive placebo or FB825 in a 1:1 ratio. Eligibility will be checked in patients with allergic asthma during the 4-week screening period. Potential candidates should provide signed informed consent forms before starting any screening activities. The subjects will receive one dose of 8 mg/kg FB825 or placebo, and five doses of 4 mg/kg FB825 or placebo every 4 weeks subsequently. The study drug will be administered as a 1-hour IV infusion. Patients may administer albuterol (or equivalents) as rescue medications as needed throughout the study. Prior to screening, patients must be on a stable dose of any of formulations of ICS/LABA combination therapy for at least 1 month. Patients who have been on medium to high dose medication according to the GINA guidelines (GINA, 2021) maintained at randomization (Day 1) will remain on their current treatment as background therapy. ICS/LABA combination therapy during background therapy stable phase (Day -28 to Day 28) followed by ICS (fluticasone or equivalent) during ICS tapering phase (Day 29 to Day 112 or Day 140), and then followed by the FB825 monotherapy phase (Day 113 or Day 141 to Day 168). Upon completing 24 weeks of treatment with the investigational product, patients will be placed on ICS/LABA combination therapy and albuterol (or equivalents) (as needed) to control their symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or females 18-75 years old.
- •Subjects diagnosed with moderate-to-severe allergic asthma \[Global Initiative for Asthma \[GINA\]; GINA, 2021) at least 12 months prior to Visit
- •Documented reversibility from historical data of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol/salbutamol (or other standard office practice) OR documented airway hyperresponsiveness (methacholine PC20 \< 8 mg/mL \[or PC20 \< 16 mg/mL on ICS\]) OR airflow variability in clinic FEV1 \>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Visit 1 if documented reversibility and airway hyperresponsiveness data are not available.
- •Subjects must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.
- •Subjects must have received a physician-prescribed asthma regimen with medium- or high-dose ICS plus LABA for at least 3 month prior to Visit 1 and the dose of ICS must be stable for at least 30 days prior to Visit 1 and throughout the screening period.
- •High-dose ICS is defined as total daily dose of \>500 mcg fluticasone propionate or equivalent
- •Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone propionate or equivalent.
- •Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2021)
- •According to the medical history, subject have no more than a maximum of 2000 mcg/day equipotent ICS daily dosage of fluticasone propionate or equivalent in 3 months before visit
- •Prior to screening, subjects must be on a stable dose of any of the following doses and formulations of ICS/LABA combination therapy for at least 1 month:
Exclusion Criteria
- •Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. Subjects are allowed to be rescreened 30 days after completion of treatment.
- •\>20% relative change in post-bronchodilator FEV1 between screening and randomization.
- •Female subjects who are pregnant or lactating.
- •A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or subject taking antiretroviral medications, as determined by medical history.
- •Patients with positive HBeAg or HCV RNA results should be excluded as they are indications of active Hepatitis B virus and Hepatitis C virus replication.
- •Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other than allergic asthma.
- •Use of any experimental drug within 30 days or 5 half-lives, whichever is longer, prior to or during the screening period.
- •Current or history of treatment with a monoclonal antibody, for example, IL-4, IL-5, IL-13 or IL-15 antibody treatment within 6 months prior to the screening.
- •Current or history of treatment with anti-IgE antibody treatment within 6 months or 5 half-lives, whichever is longer.
- •The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
Arms & Interventions
FB825
Intervention: FB825
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Occurrence of an exacerbation of asthma at week 24 after first dosing.
Time Frame: week 24
Secondary Outcomes
- Mean change in morning peak expiratory flow (PEF) from baseline(week 12, 16, and 24)
- Change in ACQ 5 from baseline(week 12, 16, and 24)
- Percentage of patients achieving decrease in score by greater than or equal to 0.5 points on the ACQ (with a minimal importance difference improvement)(week 12, 16, and 24)
- Change in FEV1 from baseline(week 12, 16, and 24)
- Occurrence of an exacerbation of asthma(week 12 and 16)
- The incidence of treatment emergent adverse events throughout the study(Week 24)