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

NCT05008965 | Recruiting Phase 2 FDA Drug

• 1 other identifier: FB825CLCT03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 13

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.

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Occurrence of an exacerbation of asthma at week 24 after first dosing.

  week 24

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Change in Total IgE from baseline

  week 12, 16, and 24

Study Arms (2)

FB825

EXPERIMENTAL

Drug: FB825

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FB825 DRUG

FB825 will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

FB825

Placebo DRUG

Placebo will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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 1.
• 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:
• Fluticasone/salmeterol combination therapy
• Advair® Diskus - dry powder inhaler (DPI): 250/50 μg BID or 500/50 μg BID, or
• Advair® HFA - metered dose inhaler (MDI): 230/42 μg BID or 460/42 μg BID, or
• Budesonide/formoterol combination therapy (Symbicort® -160/4.5 μg BID or 320/9 μg BID), or
• Mometasone/formoterol combination therapy (Dulera® -200/10 μg BID or 400/10 μg BID).

You may not qualify if:

• 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.
• The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.
• The subject has indication of severe liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate transaminase (AST) above 3x upper limits of normal (ULN) or elevated total bilirubin \>2x ULN as determined at screening.
• The subject has severe kidney disease, defined as estimated GFR \<30ml/min/1.73m2 or creatinine \> 3x ULN.
• The subject has known or suspected history of immunosuppression or immunodeficiency.
• Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and/or interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead
• Microbio Shanghai Co., Ltd.: collaborator

Study Sites (13)

Kaohsiung Chang Gung Medical Foundation

Kaohsiung City, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Far Eastern Memorial Hospital

New Taipei City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Taichung Venterans General Hospital

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

Ministry of Health and Welfare Shuang-Ho Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Sam Kuo

  Oneness Biotech Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June Kuo

CONTACT

+886 2 2703 1098; June.Kuo@onenessbio.com.tw

Pei-Jin Ho

CONTACT

+886 2 2703 1098; Peijin.Ho@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: August 17, 2021
• Study Start: July 27, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TW (13)