A Study of KT-621 for Moderate to Severe Eosinophilic Asthma
This study is testing an oral drug called KT-621 for adults with moderate to severe eosinophilic asthma (a type of asthma where a specific white blood cell, eosinophil, is elevated). The main goals are to see how well KT-621 works, if it's safe, and how it acts in the body. You might be able to join if you are between 18 and 75 years old and have had an asthma diagnosis for at least one year. Researchers will measure changes in your lung function (FEV1) over 12 weeks to see if KT-621 is effective. The study is currently unclear on its recruitment status and plans to enroll 264 participants.
- Study design
- This is a Phase 2b interventional study. It will compare KT-621 to a placebo (an inactive substance that looks like the study drug) in 264 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes up to Week 12, suggesting follow-up for at least this duration.
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NCT07323654
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Recruiting
PHASE2Ages 18–75InterventionalTreatmentKymera Therapeutics, Inc.
~264 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:KT-621Placebo
At a glance
Recruiting sites
71 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in pre-bronchodilator FEV1
Measured over From baseline to Week 12
Conditions
Where it's being run
71 sites across 27 statesPoland9
California6
Florida6
United Kingdom6
Spain5
Argentina4
Serbia4
Pennsylvania3
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Change from baseline in pre-bronchodilator FEV1From baseline to Week 12