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New treatment option for Eosinophilic Asthma
Official title A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
ClinicalTrials.gov ID: NCT07323654
What this study is testing
What is KT-621?
KT-621 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eosinophilic asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma. The main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time...
- Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.
- Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen...
- Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization.
- Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization.
You likely can't join if
- Must not have any clinically significant pulmonary disease other than asthma.
- Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or...
- Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with...
- Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
- Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
- Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621...
See the full eligibility criteria
- Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.
- Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.
- Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12...
- Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization.
- Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization.
- Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits.
- Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening.
- Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\^9/L at Screening.
- Must have a documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care...
- Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of...
- Must not have any clinically significant pulmonary disease other than asthma.
- Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma...
- Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures.
- Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
- Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
- Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.
- Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
- Must not be a current smoker of nicotine/tobacco as well as non-nicotine products, have a smoking history of ≥ 10 pack years, or use vaping products, including electronic cigarettes. Former smokers with a smoking...
- Must not have a known sensitivity to any of the components of KT-621.
- Must not be a member of the investigational team or his/her immediate family.
The study team makes the final eligibility decision.
Where it's taking place
- Lancaster, California, United States
- Long Beach, California, United States
- Northridge, California, United States
- Redding, California, United States
- Upland, California, United States
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Tampa, Florida, United States
- East Point, Georgia, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Chapel Hill, North Carolina, United States
- Toledo, Ohio, United States
- Edmond, Oklahoma, United States
- Clackamas, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- North Charleston, South Carolina, United States
+ 35 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lancaster, California, United States; Long Beach, California, United States; Northridge, California, United States; Redding, California, United States; Upland, California, United States; Loxahatchee Groves, Florida, United States and 49 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.