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CBP-201 for Asthma
Study Summary
This trial will study whether an experimental drug is effective and safe for people with moderate to severe asthma that isn't well controlled by current treatments.
- Asthma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 226 Patients • NCT04444752Trial Design
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- You have been using a certain type of inhaler with high doses of corticosteroids and another medication for at least 90 days before the screening visit, and your dosage has not changed for at least 28 days before the screening visit.You are eligible if you are taking a certain amount of inhaled steroids and another medication to manage your asthma.You can participate if your asthma is not well-controlled with two medications and you need a third one.You have had a serious asthma attack within the last month before the study starts.You have received or plan to receive a live vaccine within 7 days of screening or during the study.You cannot have taken any experimental non-biological drugs in the 30 days before the trial or 5 half-lives, whichever is longer.You have tried dupilumab before, but it did not work well for you.You are between 18 and 75 years old, and you have been diagnosed with asthma by a doctor for at least a year according to the GINA 2020 Guidelines.You have had an asthma attack within the last 12 months.You have consumed drugs or alcohol excessively in the past year.You have a history of severe allergic reactions to biologic drugs or are allergic to L-histidine, trehalose, or Tween 80.You have a respiratory disorder that is not asthma or any disease that causes high levels of eosinophils in the blood.If you take corticosteroid pills every day, the dose should not be higher than 10 mg of prednisone or its equivalent. You should have been taking the same dose for at least 28 days before the screening.Your lung function, as measured by FEV1, needs to be between 40-85% of what is expected for someone of your age, height, and gender at the screening and before taking medication.You are between 18 and 75 years old and have been diagnosed with asthma by a doctor for at least a year, according to the GINA 2020 Guidelines.
- Group 1: CBP-201 Dose 1
- Group 2: CBP-201 Dose 2
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research currently have open enrollment?
"Affirmative. Clinicaltrials.gov confirms that this medical trial, which was first posted on May 11th 2021, is actively recruiting participants. The study requires a total of 306 patients and will be hosted in two distinct clinical facilities."
To what extent could CBP-201 put the health of participants at risk?
"Given the fact that this is a Phase 2 clinical trial, with safety data but no proof of efficacy yet, CBP-201 receives an estimated score of 2."
Does this study encompass individuals under the age of thirty?
"This medical trial is open to all people aged 18-75. There are, however, 137 clinical trials specifically for minors and 457 studies that only accept applicants over 65 years of age."
How many individuals are engaged in this clinical exploration?
"Indeed, clinicaltrials.gov has confirmed that this medical trial is actively enrolling patients. This research was initially posted on May 11th 2021 and then most recently adjusted on August 23rd 2022. The investigators are searching for 306 individuals to participate at 2 distinct locations."
Could I be considered for enrollment in this experiment?
"This medical trial is open to 306 adults aged 18-75 who are suffering from inflammation. Furthermore, participants must adhere to the following requirements: a physician's diagnosis of asthma based on GINA 2020 Guidelines; maintenance treatment with medium/high dose ICS; optional additional reliever/controller (LABA, LTRA, LAMA); potential use of third controller if necessary; daily OCS dose ≤ 10 mg prednisone or equivalent that has been consistent for 28 days prior to screening; prebronchodilator FEV1 between 40-85% at both Screening and Predose Baseline."
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