CBP-201 for Asthma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Connect Investigative Site 220, Shenyang, ChinaAsthmaCBP-201 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Asthma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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4.7 microCi 225Ac-MTI-201

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: at Weeks 1, 2, 4, 8, 12 and 24

Week 24
Change in other lung function measurements
Proportion of patients with ≥ 1 asthma exacerbation
Time to severe exacerbation and number of events
Week 32
Incidence, type and severity of Adverse Event (AE)
Pharmacokinetics (Steady-state trough PK profile)
at Week 12
Absolute change in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1)
Week 1
Absolute change in prebronchodilator (trough) FEV1
Week 1
Percent change in prebronchodilator (trough) FEV1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
oral minoxidil
1
225Ac-J591
1
4.7 microCi 225Ac-MTI-201

Trial Design

3 Treatment Groups

CBP-201 Dose 1
1 of 3
CBP-201 Dose 2
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

306 Total Participants · 3 Treatment Groups

Primary Treatment: CBP-201 · Has Placebo Group · Phase 2

CBP-201 Dose 1
Drug
Experimental Group · 1 Intervention: CBP-201 · Intervention Types: Drug
CBP-201 Dose 2
Drug
Experimental Group · 1 Intervention: CBP-201 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBP-201
2020
Completed Phase 2
~230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at weeks 1, 2, 4, 8, 12 and 24

Who is running the clinical trial?

Suzhou Connect Biopharmaceuticals, Ltd.Lead Sponsor
8 Previous Clinical Trials
923 Total Patients Enrolled
Suzhou ConnectStudy DirectorSuzhou Connect Biopharmaceuticals, Ltd.
8 Previous Clinical Trials
933 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients receiving budesonide/formoterol with budesonide ≥ 640 μg/day are eligible.
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.
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.
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 are eligible if you need a third medication to manage your asthma.
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.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Connect Investigative Site 115100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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