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

ConditionAllergic Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOneness Biotech Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FB825

    Drug

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

  • Placebo

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: FB825Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
week 24

Secondary outcomes

1

Mean change in morning peak expiratory flow (PEF) from baseline

Time frame
week 12, 16, and 24
2

Change in ACQ 5 from baseline

Time frame
week 12, 16, and 24
3

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)

Time frame
week 12, 16, and 24
4

Change in FEV1 from baseline

Time frame
week 12, 16, and 24

Other outcomes

1

Change in Total IgE from baseline

Time frame
week 12, 16, and 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oneness Biotech Co., Ltd.

Lead sponsor

Microbio Shanghai Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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