Recruiting PHASE2 Allergic Asthma

Tests treatment safety and results for Allergic Asthma

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

ClinicalTrials.gov ID: NCT05008965

What this study is testing

What is FB825?

FB825 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for allergic asthma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Male or females 18-75 years old.
  • people 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...
  • people must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.
  • people 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...

You likely can't join if

  • Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. people are allowed to be rescreened 30...
  • \>20% relative change in post-bronchodilator FEV1 between screening and randomization.
  • Female people 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...
  • Patients with positive HBeAg or HCV RNA results should be excluded as they are indications of active Hepatitis B virus and Hepatitis C virus...
  • Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other than allergic asthma.
See the full eligibility criteria
Who can join
  • Male or females 18-75 years old.
  • people 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...
  • people must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.
  • people 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...
  • 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, people 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).
  • Other equivalents medium to-high dose medication following the GINA guidelines (GINA, 2021)
  • people must have a documented history of protocol-defined asthma exacerbation at least 1 or more times within the 12 months.
  • A total serum IgE ≥ 125 IU/mL during screening prior to randomization.
  • people must have at least one positive in skin prick test or at least one environmental allergen-specific IgE greater than normal range.
  • Uncontrolled asthma demonstrated both during the screening period and at the time of randomization defined as ACQ-5 (5-item Asthma Control Questionnaire) ≥ 1.5
  • If recently treated for respiratory tract infection, the treatment must have been completed at least 4 weeks prior to screening. people who have an upper respiratory tract infection during screening are allowed to be...
  • Female people of childbearing potential must use at least two forms of birth control. One must be barrier protection (i.e., condom or female condom) and the other is one of acceptable method of birth control (ie...
  • The subject has a body weight ≥ 40 kg at screening.
  • The subject has a normal or non clinically significant abnormal, as determined by the investigator, 12-lead electrocardiogram (ECG).
  • The subject is able to provide written informed consent.
  • The subject agrees to comply with all protocol requirements.
What rules you out
  • Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. people are allowed to be rescreened 30 days after completion of treatment.
  • \>20% relative change in post-bronchodilator FEV1 between screening and randomization.
  • Female people 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...
  • The subject has severe kidney disease, defined as estimated GFR \ 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...
  • The subject has history of malignancy within 5 years before the screening period. Patients with non-invasive carcinoma in-situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin may be eligible...
  • Current smoker with \> 10 packs year prior to screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.
  • High risk of parasite infection
  • Risk factors for parasitic disease (living in an endemic area, travel within the last 6 months to regions where geohelminthic infections are endemic, and/or chronic immunosuppression). AND
  • Evidence of parasitic colonization or infection on stool evaluation for ova and parasites. Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than...
  • The subject has received live vaccine within 12 weeks or COVID-19 vaccination within 2 weeks prior to dosing or planned live attenuated vaccinations during the study.
  • The subject has a history of any clinically relevant arrhythmias as determined by the investigator.
  • The subject has a history of respiratory failure or near fatal asthma events which resulted in intensive care unit admission or intubation within five years before the screening period.
  • History of anaphylaxis to any biologic therapy.
  • The subject has major surgery, for example organ replacement, joint replacement, full hysterectomy, heart surgeries, within 8 weeks before the screening. The subject who has major surgery prior to 8 weeks of screening...
  • The subject has comorbid disease that might interfere with the evaluation of IMP (investigational medicinal product) or conduct of study procedures (eg, bronchodilator test).
  • The subject requiring non-selective beta-adrenergic receptor blockers for any reason and initiation or dose change of a selective beta-1 adrenergic receptor blocker within 3 months prior to Visit 1.
  • The subject who received bronchial thermoplasty within 3 years of Visit 1 OR patients who plan to begin therapy during the Screening Period or the assigned by chance Treatment Period.
  • The subject with active autoimmune disease (excluding atopic dermatitis) or patients using immunosuppressive therapy for autoimmune disease (excluding atopic dermatitis) (eg, rheumatoid arthritis, inflammatory bowel...
  • Use of Traditional Chinese Medications, those that are listed in the Prohibited Medication, for the treatment of asthma within 3 months prior to screening.
  • Aggravating factors that are inadequately controlled e.g., medication uncontrolled gastroesophageal reflux disease.
  • The subject has adrenal insufficiency (ACTH-resistant) by rapid ACTH stimulation test due to known history of adrenal insufficiency or being suspected of adrenal insufficiency or long-term use of systemic...
  • History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT/PCR) within 3 months prior to screening.

The study team makes the final eligibility decision.

Where it's taking place

  • Kaohsiung City, Taiwan
  • New Taipei City, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Kaohsiung City, Taiwan; New Taipei City, Taiwan; Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.