RecruitingPhase 2NCT05018299

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma

A Randomized, Placebo Controlled, Double Blind Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Multiple Intravenous Doses of FB704A in Adults With Severe Asthma


Sponsor

Oneness Biotech Co., Ltd.

Enrollment

20 participants

Start Date

Sep 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new biologic drug called FB704A in adults with severe asthma that is not well-controlled. The drug targets neutrophils — a type of immune cell involved in certain types of difficult-to-treat asthma. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with severe asthma (according to international guidelines) - Your asthma symptoms are poorly controlled (ACT score below 20) - A high proportion of your sputum cells are neutrophils (50% or more) - Your asthma diagnosis is documented from within the past 5 years - You show evidence of airway reversibility or airway hyperresponsiveness on breathing tests **You may NOT be eligible if...** - You have mild or moderate (not severe) asthma - Your asthma does not involve neutrophil-dominated inflammation - You are pregnant or breastfeeding - You have other serious lung diseases, active infections, or autoimmune conditions - You are already taking certain biologic asthma treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFB704A placebo

Placebo

BIOLOGICALFB704A

Anti-IL-6 antibody


Locations(9)

NTUH Hsin-Chu Branch

Hsinchu, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05018299


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