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

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ClinicalTrials.gov Identifier: NCT04773678
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Connect Biopharmaceuticals, Ltd.

Tracking Information
First Submitted Date  ICMJE February 24, 2021
First Posted Date  ICMJE February 26, 2021
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE May 11, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
Absolute change in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1) [ Time Frame: at Week 12 ]
Absolute change from Baseline in prebronchodilator (trough) FEV1 at Week 12. To assess the efficacy of CBP-201 (Dose 1 and Dose 2) versus placebo in patients with moderate to severe persistent asthma with type 2 inflammation as measured by lung function improvements.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
  • Absolute change in prebronchodilator (trough) FEV1 [ Time Frame: at Weeks 1, 2, 4, 8 and 24 ]
    Absolute change from Baseline in prebronchodilator (trough) FEV1 at Weeks 1, 2, 4, 8 and 24.
  • Percent change in prebronchodilator (trough) FEV1 [ Time Frame: at Weeks 1, 2, 4, 8, 12 and 24 ]
    Percent change from Baseline in prebronchodilator (trough) FEV1 at Weeks 1, 2, 4, 8, 12 and 24.
  • Change in other lung function measurements [ Time Frame: From Baseline to Week 24 ]
    Change from Baseline in other lung function measurements [percentage predicted FEV1, morning and evening peak expiratory flow (PEF)].
  • Time to severe exacerbation and number of events [ Time Frame: From Baseline to Week 24 ]
    Time to severe exacerbation and number of events during the 24 weeks Treatment Period.
  • Proportion of patients with ≥ 1 asthma exacerbation [ Time Frame: From Baseline to Week 24 ]
    Proportion of patients with ≥ 1 asthma exacerbation during the 24 weeks Treatment Period.
  • Incidence, type and severity of Adverse Event (AE) [ Time Frame: From Baseline to Week 32 ]
    Safety endpoints will be summarized by descriptive statistics and narratives where indicated by severity. Safety will be assessed on basis of AEs reported, including SAEs and AESIs.
  • Pharmacokinetics (Steady-state trough PK profile) [ Time Frame: From Baseline to Week 32 ]
    Whole blood for plasma CBP-201 concentrations will be obtained and analyzed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing the Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation
Official Title  ICMJE A Multicenter, 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
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Persistent Asthma
Intervention  ICMJE
  • Drug: CBP-201
    CBP-201 subcutaneous (SC) injection.
  • Drug: Placebo
    Placebo subcutaneous (SC) injection.
Study Arms  ICMJE
  • Experimental: CBP-201 Dose 1
    CBP-201 Dose 1 subcutaneous (SC) injection.
    Intervention: Drug: CBP-201
  • Experimental: CBP-201 Dose 2
    CBP-201 Dose 2 subcutaneous (SC) injection.
    Intervention: Drug: CBP-201
  • Placebo Comparator: Placebo
    Placebo subcutaneous (SC) injection.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2021)
306
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2021)
294
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 the Global Initiative for Asthma (GINA) 2020 Guidelines.
  2. 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 ≥ 250 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.
  3. 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.
  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.
  5. For patients not requiring maintenance OCS, blood eosinophil count ≥ 150 cells/μL at Screening. An eosinophil count of ≥ 150 cells/μL in the medical record from the past 12 months may also be used to fulfil this criterion.
  6. Asthma Control Questionnaire, 6-question (ACQ-6) 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.
  8. Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques during the 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.
  10. Patient demonstrates at least 70% compliance with recording of symptom scores in the patient-reported outcomes (PRO) diary completion during Run-in Period.
  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. Non-sterilized 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.
  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.

    Exclusion Criteria:

    -

    A patient who meets any of the following criteria will be ineligible to participate in this study:

  15. 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).
  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. Note: Patients must be symptom-free for at least 30 days.
  17. Patient experiences a severe asthma exacerbation at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit. Exacerbation is defined 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.
  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 (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.
  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 (e.g. therapy failure or patient experienced an adverse reaction to 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.
  25. 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).
  26. Patient has positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb) 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 (eg, influenza receiving only symptomatic 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, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
  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.
  32. 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).
  33. Patient has a prolonged corrected QT (QTc) interval (male > 450 milliseconds, female > 470 milliseconds) or tachyarrhythmia.
  34. Patient has any of the following laboratory abnormalities at Screening:

    • Eosinophils > 1500 cells/mmE3 or 1.5*10E9/L
    • Platelets < 100000 cells/mmE3 or 100*10E9/L
    • Creatine phosphokinase (CPK) > 10 times the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) > 2.5 times the ULN
    • Aspartate aminotransferase (AST) ≥ 2.5 times the ULN
    • Bilirubin > 2 times the ULN.
  35. Patient has a history of alcohol or drug abuse within 12 months of Screening.
  36. 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.
  37. 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.
  38. Female patient is pregnant, planning to become pregnant, or is breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malinda Longphre, PhD +15105203361 mlongphre@connectpharm.com
Contact: Maryam Yaghini +14156106887 myaghini@connectpharm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04773678
Other Study ID Numbers  ICMJE CBP-201-WW002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suzhou Connect Biopharmaceuticals, Ltd.
Study Sponsor  ICMJE Suzhou Connect Biopharmaceuticals, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suzhou Connect Suzhou Connect Biopharmaceuticals, Ltd.
PRS Account Suzhou Connect Biopharmaceuticals, Ltd.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP