RecruitingPhase 2

A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants With Uncontrolled Moderate to Severe Eosinophilic Asthma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests KT-621, a medicine taken by mouth, in adults with moderate to severe eosinophilic asthma that is not well controlled. This type of asthma involves white blood cells called eosinophils. The study looks at how well the medicine works, its safety and side effects, and how it acts in the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 75 when signing the consent form, or meet the local legal age for consent.
  • Have asthma diagnosed by a doctor at least 1 year before screening.
  • Use a medium- or high-dose inhaled steroid plus a long-acting medicine that opens the airways. Use the required asthma medicine plan for at least 12 weeks, with no dose or schedule changes for at least 4 weeks before screening through the baseline visit.
  • At screening and baseline, have a breathing test result called FEV1 of 40% to 80% of normal before airway-opening medicine, and an asthma control score of at least 1.5.
  • At screening and baseline, have a breath test showing airway swelling, called FeNO, of at least 25 ppb. At screening, have at least 300 eosinophils, a type of white blood cell, per microliter of blood.
  • At screening, have breathing improve by at least 12% and 200 mL after taking airway-opening medicine.
  • Have at least 1 asthma flare-up in the past 52 weeks that needed steroid pills or shots, a hospital stay, or emergency or urgent care.
  • Agree to the study's birth control rules and be able to follow all visits, treatments, tests, procedures, surveys, and the electronic diary.

Who can't join

  • Have a serious lung disease other than asthma, or another health condition or factor that could affect safety, following study rules, or study results.
  • Have an asthma flare-up needing steroid pills or shots, a hospital stay, or emergency or urgent care from 4 weeks before screening through the baseline visit.
  • Be pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
  • Have safety lab test results outside the local normal range at screening.
  • Have received an experimental drug or device too recently: within 8 weeks before KT-621, or 5 drug half-lives, whichever is longer. A half-life is the time it takes for half a drug to leave the body.
  • Currently smoke or vape, or have smoked at least 10 pack-years, such as 1 pack a day for 10 years. Former smokers with less smoking history and former vape users must have stopped at least 26 weeks before screening.
  • Have a known sensitivity to any ingredient in KT-621.
  • Be on the study team or be an immediate family member of someone on the team.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits. * 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 visit for acute asthma worsening within the past 52 weeks prior to Screening. * 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 the study as required by the study protocol. Exclusion Criteria: * 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 worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit. * 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 history of \< 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit. * 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.

Study sites (34)

CA

CO

CT

FL

GA

IA

KS

KY

MA

NC

OH

OK

OR

PA

SC

TN

TX

WI