A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Efficacy and Safety Study of CBP-201 in Patients with Moderate to Severe Persistent Asthma with Type 2 Inflammation.

Suzhou Connect Biopharmaceuticals Ltd.0 个研究点目标入组 306 人开始时间: 2021年10月6日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Suzhou Connect Biopharmaceuticals Ltd.
入组人数: 306

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Adult male or female patient aged 18 to 75 years with a physician diagnosis of asthma for a minimum of 12 months, based on GINA 2020 Guidelines.
•2. Patient is currently receiving treatment with medium to high dose ICS in combination with at least 1 additional reliever/controller for at least 90 days prior to the Screening Visit with a stable ICS dose at least 28 days prior to the Screening Visit.
•3. Prebronchodilator (trough) FEV1 must be 40 to 85% of predicted normal at Screening and predose Baseline.
•4. 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. Note: Patients may repeat reversibility testing on a different day if the first attempt fails and justification is documented (eg, technical issues, reason to suspect that a longer bronchodilator washout is needed).
•5. Blood eosinophil count = 300 cells/µL at Screening. Note: Patients
•consented on previous version of the protocol will not be considered
•ineligible based on lower eosinophil counts at screening, or at baseline,
•or in the medical history. Also, for patients on maintenance OCS
•consented on previous version of the protocol will not be considered
•ineligible regardless of eosinophil count.
•Note: If patients' eosinophils are less than 300 cells/µL at Screening,
•labs may be repeated once within 28-day Screening Period otherwise
•they will be screen failed.
•6. Six-question Asthma Control Questionnaire (ACQ) score = 1.5 at Screening and Baseline.
•7. Patient has experienced an asthma exacerbation at least once in the past 12 months, defined here as:
•- Use of physician prescribed systemic corticosteroid [oral or parenteral], or
•- Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
•- Hospitalization or emergency medical care due to asthma.
•Note: If patient is maintained on oral steroids, exacerbation requiring an increase in dose of at least 2-fold is considered adequate to fulfil this criterion. In the event the physician is uncertain that a patient meets the criteria of exacerbation defined within the protocol, the Medical Monitor(s) should be contacted for consultation.
•8. Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques during Screening Period, in the opinion of the Investigator.
•9. 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.
•10. Patient demonstrates at least 70% compliance with recording of
•symptom scores in patient-reported outcomes (PRO) diary completion
•during Run-in Period and in their hand-held pulmonary function device in
•the 7 days prior to dosing.
•11. Patient is able to understand and willing to sign the informed consent form (ICF).
•12. Patient is willing and able to comply with clinic visit schedule and study-related procedures, in the opinion of the Investigator.
•13. Male patients and their female partners agree to practice adequate and effective forms of contraception through the duration of the study from first dose to 8 weeks beyond the last dose of study drug (see Section 4.5.3).
•14. 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 (see Section 4.5.3).
•Are the trial subjects under 1

排除标准

•15. Patient has a current diagnosis of a respiratory disorder other than asthma or other disease associated with elevated peripheral eosinophil counts.
•16. 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.
•17. Patient experiences an asthma exacerbation at any time from 1 month prior to Screening up to and including the Baseline Visit. Exacerbation is defined as:
•- Use of physician prescribed systemic corticosteroid, or
•- Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
•- Hospitalization or emergency medical care due to asthma.
•18. Current smoker or former smoker with a smoking history of > 10 pack-years. Note: This includes tobacco, marijuana, and vaping products.
•19. Patient is undergoing or planning to undergo any elective surgery during the study requiring general anesthesia.
•20. Patient has received treatment with any marketed or investigational biologic drug for asthma or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
•21. Patient has received treatment with any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.
•22. Patient did not respond favorably to previous dupilumab treatment.
•23. 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.
•24. Patient is receiving medications or therapy that are prohibited as concomitant medications (See Section 4.5.1).
•25. Patient has a known or suspected history of immunosuppression, including history of invasive opportunistic infections regardless of infection resolution; or unusually frequent, recurrent, or prolonged infections.
•26. Patient has positive results at Screening for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with positive HCV RNA polymerase chain reaction; or positive HIV serology at Screening.
•27. 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.
•28. 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.
•29. Patient receives live (attenuated) vaccinations within 7 days of Screening or plans to receive live (attenuated) vaccinations during the study.
•30. 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.
•31. 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.

研究者

发起方

Suzhou Connect Biopharmaceuticals Ltd.

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