CompletedPhase 2

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

United States322 participantsStarted 2021-05-11

Plain-language summary

This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Adult male or female patient aged 18 to 75 years with a physician diagnosis of asthma for a minimum of 12 months, based on the Global Initiative for Asthma (GINA) 2020 Guidelines.
✓. Patient is currently receiving treatment with medium to high dose inhaled corticosteroids (ICS) in combination with at least 1 additional reliever/controller for at least 90 days prior to the Screening Visit with a stable dose of ICS at least 28 days prior to the Screening Visit.
✓. Prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1) must be 40 to 85% of predicted normal at Screening and predose Baseline.
✓. Patients must have ≥ 12% reversibility (and ≥ 200 mL difference) in FEV1 within 15 to 30 minutes after the administration of up to 4 puffs of albuterol/salbutamol at Screening.
✓. Blood eosinophil count ≥ 300 cells/μL at Screening.
✓. Asthma Control Questionnaire, 6-question (ACQ-6) score ≥ 1.5 at Screening and Baseline.
✓. Patient has experienced an asthma exacerbation at least once in the past 12 months, defined here as:
✓. Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques during the Screening Period in the opinion of the Investigator.

Exclusion criteria

✕5. Patient has a current diagnosis of a respiratory disorder other than asthma (eg, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis) or other disease associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
✕6. Patient has an acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 30 days prior to the date of informed consent or during the Screening/Run-in Period. Note: Patients must be symptom-free for at least 30 days.
✕7. Patient experiences ana asthma exacerbation at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit. Exacerbation is defined as:
✕8. Current smoker or former smoker with a smoking history of \> 10 pack-years. Note: This includes tobacco, marijuana, and vaping products.
✕9. Patient is undergoing or planning to undergo any elective surgery during the study requiring general anesthesia.
✕0. Patient has received treatment with any marketed (eg, omalizumab, benralizumab, mepolizumab, reslizumab, dupilumab) or investigational biologic drug for asthma or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
✕1. Patient has received treatment with any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.
✕2. Patient did not respond favorably to previous dupilumab treatment (e.g. therapy failure or patient experienced an adverse reaction to treatment).

What they're measuring

Absolute change in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1)

Timeframe: at Week 12

Trial details

NCT IDNCT04773678

SponsorConnect Biopharm LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-05

View on ClinicalTrials.gov More Moderate to Severe Persistent Asthma trials