NCT05008965

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	FB825	FB825 will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.
DRUG	Placebo	Placebo will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

Timeline

• Start date: 2021-07-27
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-08-17
• Last updated: 2026-01-12

Locations

13 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study