Phase 2 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old.
• People who have been diagnosed with moderate-to-severe allergic asthma for at least 12 months before the first study visit.
• People whose medical records show that their airways respond to a reliever inhaler (such as albuterol/salbutamol), or that their airways are unusually sensitive to triggers, or that their lung function varies significantly between clinic visits — with supporting records from the past 24 months (confirm with trial site).
• People whose lung function test result (called FEV1, a measure of how much air can be blown out) falls within a specific range — at least 40% but no more than 80% of the expected value — measured within 2 months before joining the trial.
• People who have been prescribed a combination asthma inhaler containing a medium or high dose of a steroid (ICS) plus a long-acting reliever (LABA) for at least 3 months, with the steroid dose unchanged for at least 30 days before the first visit.
• People who are currently using one of the following specific combination inhalers at a stable dose for at least 1 month: fluticasone/salmeterol (Advair® Diskus or HFA), budesonide/formoterol (Symbicort®), mometasone/formoterol (Dulera®), or an equivalent medium-to-high dose combination inhaler as defined by GINA guidelines.
• People who have had at least one serious asthma flare-up (as defined by the trial protocol) in the past 12 months.
• People whose blood test shows a total IgE level (an allergy-related protein) of 125 IU/mL or higher during the screening period.
• People who test positive to at least one common environmental allergen, either through a skin prick test or a blood test.
• People whose asthma remains poorly controlled, shown by a score of 1.5 or higher on a standard 5-question asthma control survey (ACQ-5), both during screening and at the time of joining the trial.
• People who have completed treatment for a respiratory tract infection at least 4 weeks before screening (those who get an upper respiratory infection during screening may re-screen 4 weeks after recovering).
• Women who could become pregnant must use two forms of contraception — one must be a barrier method (such as a condom) and the other an additional approved method — throughout the study and for at least 120 days after the last dose. Women who have had a hysterectomy, both fallopian tubes tied, both ovaries removed, or who have gone through menopause (no periods for 12 consecutive months with a confirming blood test) are not required to meet this criterion.
• Women of childbearing potential must have a negative pregnancy blood test at screening.
• People who weigh at least 40 kg at screening.
• People whose heart tracing (ECG) is normal or shows no clinically significant findings, as judged by the investigator.
• People who are able to provide written consent to participate.
• People who agree to follow all requirements of the trial protocol.

Who may not be able to join:

• People who have had a serious asthma flare-up, or needed steroid tablets or injections for any reason, in the 30 days before joining (re-screening may be possible 30 days after finishing treatment).
• People whose lung function test result changes by more than 20% between the screening visit and the point of joining the trial.
• Women who are pregnant or breastfeeding.
• People who test positive for HIV at screening, or who are currently taking antiretroviral (HIV) medications.
• People with active Hepatitis B or Hepatitis C virus, shown by positive test results for HBeAg or HCV RNA.
• People with active lung diseases other than allergic asthma, such as bronchitis or chronic obstructive pulmonary disease (COPD).
• People who have taken any experimental (investigational) drug within 30 days, or within 5 times the drug's half-life, whichever is longer, before or during the screening period.
• People who have been treated with certain types of biologic medicines (monoclonal antibodies targeting IL-4, IL-5, IL-13, or IL-15) within the past 6 months.
• People who have been treated with an anti-IgE antibody therapy within 6 months, or within 5 times the drug's half-life, whichever is longer.
• People with a history of alcohol or drug misuse that the investigator believes would affect safe or full participation in the study.
• People with any condition that the investigator believes could affect the study results or the person's wellbeing, or prevent them from completing study tasks.
• People with signs of serious liver disease, based on blood test results at screening.
• People with serious kidney disease, based on kidney function measurements at screening.
• People with a known or suspected history of a weakened immune system.
• People with known active tuberculosis (TB), or evidence of a TB infection based on skin or blood tests.
• People with a history of cancer in the past 5 years. People with certain limited skin cancers or early-stage cervical changes may still be eligible if they had successful treatment at least 12 months before screening (confirm with trial site).
• People who are current smokers with more than 10 pack-years of smoking history before screening (a pack-year is smoking one pack of cigarettes per day for one year; this also includes cigars, pipes, and e-cigarettes).
• People at high risk of parasitic infection — meaning they live in or have recently travelled to an area where certain parasitic infections are common, and also have evidence of a parasitic infection on stool testing (confirm with trial site).
• People who have received a live vaccine within 12 weeks before dosing, or a COVID-19 vaccine within 2 weeks before dosing, or who plan to receive a live vaccine during the study.
• People with a history of any clinically significant irregular heart rhythm, as determined by the investigator.
• People who have had a life-threatening asthma attack requiring intensive care or a breathing tube within the past 5 years.
• People with a history of a severe allergic reaction (anaphylaxis) to any biologic medicine.
• People who have had major surgery within 8 weeks before screening, or who have not fully recovered from surgery that occurred more than 8 weeks prior.
• People with other health conditions that the investigator believes could interfere with how the study drug is assessed or with the study tests.
• People who take non-selective beta-blocker medications for any reason, or who have recently started or changed the dose of a selective beta-1 blocker within 3 months before the first visit.
• People who have had a bronchial thermoplasty procedure (a heat-based airway treatment) within 3 years before the first visit, or who plan to have this treatment during the trial.
• People with an active autoimmune disease (other than atopic dermatitis/eczema), or who are taking immune-suppressing medications for an autoimmune condition, or who have high levels of certain antibodies that may suggest a risk of developing autoimmune disease (confirm with trial site).
• People who have used certain Traditional Chinese Medicines listed as prohibited by the trial for the treatment of asthma within 3 months before screening.
• People with poorly controlled conditions that can worsen asthma, such as gastroesophageal reflux disease (acid reflux) that is not adequately managed by medication.
• People with a condition called adrenal insufficiency, where the adrenal glands do not produce enough of a stress hormone called cortisol, confirmed by a specific stimulation test — either because of a known history, suspected insufficiency, or long-term use of steroid tablets (confirm with trial site).
• People who have had a positive COVID-19 test (antigen or PCR) within 3 months before screening.

Important: Always verify eligibility with the trial site directly before applying.