Loading clinical trials...

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04773678•Connect Biopharm LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 ≥ 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.
•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.
+13 more criteria

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 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:
•* 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.
+25 more criteria

Locations (76)

Connect Investigative Site 154

Tucson, Arizona, United States

Connect Investigative Site 109

Huntington Beach, California, United States

Connect Investigative Site 143

Huntington Beach, California, United States

Connect Investigative Site 132

Lancaster, California, United States

Connect Investigative Site 125

Mission Viejo, California, United States

Connect Investigative Site 103

San Jose, California, United States

Connect Investigative Site 161

Hialeah, Florida, United States

Connect Investigative Site 114

Hollywood, Florida, United States

Connect Investigative Site 142

Leesburg, Florida, United States

Connect Investigative Site 104

Miami, Florida, United States

Key Dates

Start Date

May 11, 2021

Primary Completion Date

August 5, 2023

Completion Date

September 28, 2023

Last Updated

March 29, 2024

Enrollment

322

ACTUAL participants

Conditions

Moderate to Severe Persistent Asthma

Interventions

CBP-201

DRUG

Placebo

DRUG