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

  • STATUS
    Recruiting
  • End date
    Jul 20, 2023
  • participants needed
    306
  • sponsor
    Suzhou Connect Biopharmaceuticals, Ltd.
Updated on 4 October 2022

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.

Description

This is a multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two dose levels of CBP-201 administered to eligible patients with moderate to severe persistent asthma with Type 2 inflammation compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks.

Details
Condition Moderate to Severe Persistent Asthma
Treatment Placebo, CBP-201
Clinical Study IdentifierNCT04773678
SponsorSuzhou Connect Biopharmaceuticals, Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Note
Patients receiving ICS equivalent to ≥ 226 μg fluticasone propionate twice daily or equipotent ICS daily dosage of a maximum of 2000 μg/day fluticasone propionate (or equivalent) in combination with a second reliever/controller (eg, long-acting ß agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], theophylline) are eligible
Patients receiving fluticasone furoate/vilanterol with fluticasone furoate ≥ 200 μg once daily are eligible
Patients receiving budesonide/formoterol with budesonide ≥ 640 μg/day are eligible
Patients requiring a third reliever/controller for their asthma are eligible
Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤ 10 mg/day prednisone or equivalent OCS in addition to ICS are eligible; OCS total daily dose must have been stable at least 28 days prior to Screening
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
Patient has experienced an asthma exacerbation at least once in the past 12 months, defined here as
Blood eosinophil count ≥ 300 cells/μL at Screening
Use of physician prescribed systemic corticosteroid [oral or parenteral], or
Asthma Control Questionnaire, 6-question (ACQ-6) score ≥ 1.5 at Screening and Baseline
Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
Hospitalization or emergency medical care due to asthma
Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques
during the Screening Period in the opinion of the Investigator
Patient is able to understand and willing to sign the informed consent form (ICF)
Patient demonstrates at least 70% compliance with usual asthma controller use during Run-in Period, based on their patient diary in the 7 days prior to dosing
Patient is willing and able to comply with clinic visit schedule and study-related procedures, in the opinion of the Investigator
Patient demonstrates at least 70% compliance with recording of symptom scores in the patient-reported outcomes (PRO) diary completion during Run-in Period and in their handheld pulmonary function device in the 7 days prior to dosing
Female patients of childbearing potential who are sexually active with a non-sterilized male partner agree to practice adequate and effective forms of contraception from first dose to 8 weeks after last dose of study drug
Male patients and their female partners of child-bearing potential agree to practice adequate and effective forms of contraception through the duration of the study from first dose to 8 weeks after the last dose of study drug

Exclusion Criteria

\-
A patient who meets any of the following criteria will be ineligible to
participate in this study
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)
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
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
Hospitalization or emergency medical care due to asthma
Current smoker or former smoker with a smoking history of > 10 pack-years. Note: This
includes tobacco, marijuana, and vaping products
Patient is undergoing or planning to undergo any elective surgery during the study requiring general anesthesia
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
Use of physician prescribed systemic corticosteroid [oral or parenteral], or
Patient has received treatment with any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer
Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
Patient did not respond favorably to previous dupilumab treatment (e.g. therapy failure or patient experienced an adverse reaction to treatment)
Patient has received specific immunotherapy within 3 months prior to randomization. Note: If the patient has received immunotherapy, a 3 month washout period is required following the last dose of immunotherapy
Eosinophils > 1500 cells/mmE3 or 1.510E9/L
Patient is receiving medications or therapy that are prohibited as concomitant medications
Platelets < 100000 cells/mmE3 or 10010E9/L
Patient has a known or suspected history of immunosuppression, including history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, HIV, listeriosis, pneumocystosis, pulmonary non-tuberculosis mycobacteria, or tuberculosis, regardless of infection resolution; or unusually frequent, recurrent, or prolonged infections. Note: Tuberculosis testing will be performed on a country-by-country basis according to local guidelines if required by regulatory authorities or ethics committees (ECs)
Patient has positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbsAqHBsAq), or hepatitis C antibody (HbsAqHBsAq) with positive HCV RNA polymerase chain reaction; or positive HIV serology at Screening
Creatine phosphokinase (CPK) > 10 times the upper limit of normal (ULN)
Patient has a helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent that has not been treated with, or has failed to respond to, standard of care therapy
Alanine aminotransferase (ALT) > 2.5 times the ULN
Patient shows evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics, or antiprotozoals within 28 days of Screening, or significant viral infections within 28 days of Screening that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment)
Patient receives live (attenuated) vaccinations within 7 days of Screening or plans to receive live (attenuated) vaccinations during the study
Patient has any disorder that is not stable in the opinion of the Investigator and may affect the safety of the patient throughout the study; influence the findings of the studies or their interpretations; or impede the patient's ability to complete the entire duration of study, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment
Patient has any clinically significant abnormal findings in physical examination, vital signs, or safety lab tests during Screening/Run-in Period; or any significant medical history which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Patient is being treated with immunosuppressive therapy or biologic therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis)
Patient has a prolonged corrected QT (QTc) interval (male > 450 milliseconds, female > 470 milliseconds) or tachyarrhythmia
Patient has any of the following laboratory abnormalities at Screening
Aspartate aminotransferase (AST) ≥ 2.5 times the ULN
Bilirubin > 2 times the ULN
Patient has a history of alcohol or drug abuse within 12 months of Screening
Patient has an allergy to L-histidine, trehalose, or Tween (polysorbate) 80 or a history of a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug
Patient has a history of malignancy within 5 years prior to the Baseline Visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix and nonmetastatic squamous or basal cell carcinoma of the skin are allowed
Female patient is pregnant, planning to become pregnant, or is breastfeeding
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