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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline in pre-bronchodilator FEV1 — From baseline to Week 12
Trial sites (71)
Facility
City
Region
Status
Kymera Investigative Site
Lancaster
California
Recruiting
Kymera Investigative Site
Long Beach
California
Recruiting
Kymera Investigative Site
Northridge
California
Recruiting
Kymera Investigative Site
Redding
California
Recruiting
Kymera Investigative Site
San Francisco
California
Recruiting
Kymera Investigative Site
Upland
California
Recruiting
Kymera Investigative Site
Aurora
Colorado
Recruiting
Kymera Investigative Site
New Haven
Connecticut
Recruiting
Kymera Investigative Site
Loxahatchee Groves
Florida
Recruiting
Kymera Investigative Site
Miami
Florida
Recruiting
Kymera Investigative Site
Miami
Florida
Recruiting
Kymera Investigative Site
Miami Lakes
Florida
Recruiting
Kymera Investigative Site
Orlando
Florida
Recruiting
Kymera Investigative Site
Tampa
Florida
Recruiting
Kymera Investigative Site
East Point
Georgia
Recruiting
Kymera Investigative Site
Iowa City
Iowa
Recruiting
Kymera Investigative Site
Kansas City
Kansas
Recruiting
Kymera Investigative Site
Louisville
Kentucky
Recruiting
Kymera Investigative Site
Boston
Massachusetts
Recruiting
Kymera Investigative Site
Chapel Hill
North Carolina
Recruiting
Kymera Investigative Site
Durham
North Carolina
Recruiting
Kymera Investigative Site
Toledo
Ohio
Recruiting
Kymera Investigative Site
Edmond
Oklahoma
Recruiting
Kymera Investigative Site
Clackamas
Oregon
Recruiting
Kymera Investigative Site
Philadelphia
Pennsylvania
Recruiting
Kymera Investigative Site
Pittsburgh
Pennsylvania
Recruiting
Kymera Investigative Site
Pittsburgh
Pennsylvania
Recruiting
Kymera Investigative Site
North Charleston
South Carolina
Recruiting
Kymera Investigative Site
Rock Hill
South Carolina
Recruiting
Kymera Investigative Site
Chattanooga
Tennessee
Recruiting
Kymera Investigative Site
Dallas
Texas
Recruiting
Kymera Investigative Site
Dallas
Texas
Recruiting
Kymera Investigative Site
McKinney
Texas
Recruiting
Kymera Investigative Site
Madison
Wisconsin
Recruiting
Kymera Investigative Site
Buenos Aires
Argentina
Recruiting
Kymera Investigative Site
Concepción del Uruguay
Argentina
Recruiting
Kymera Investigative Site
Rosario
Argentina
Recruiting
Kymera Investigative Site
San Miguel de Tucumán
Argentina
Recruiting
Kymera Investigative Site
Berlin
Germany
Recruiting
Kymera Investigative Site
Leipzig
Germany
Recruiting
+ 31 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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