Actively Recruiting
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Led by Kymera Therapeutics, Inc. · Updated on 2026-04-23
264
Participants Needed
17
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent
- Physician diagnosis of asthma for at least 1 year before screening
- On stable medium to high-dose inhaled corticosteroids with a long-acting beta2-agonist, with no dose changes 4 weeks before screening
- Pre-bronchodilator FEV1 between 40% and 80% of predicted at screening and baseline
- ACQ-5 score of 1.5 or higher at screening and baseline
- FeNO level of 25 ppb or higher at screening and baseline
- Evidence of reversible airway obstruction with at least 12% and 200 mL improvement in FEV1 after bronchodilator at screening
- Absolute blood eosinophil count of at least 0.30 x 10^9/L at screening
- History of at least 1 asthma exacerbation requiring systemic corticosteroids, hospitalization, or urgent care within 52 weeks before screening
- Agree to contraceptive requirements per study and local rules
- Willing and able to comply with study visits, treatments, tests, and complete electronic diary
You will not qualify if you...
- Any clinically significant lung disease other than asthma
- Asthma exacerbation requiring systemic corticosteroids, hospitalization, or urgent care within 4 weeks before screening through baseline
- Other significant medical conditions that could affect safety or study participation
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Abnormal clinical laboratory safety test results at screening
- Use of investigational drugs or devices within 8 weeks or 5 half-lives before KT-621 dosing
- Conditions interfering with treatment compliance or study conduct
- Current smokers or those with smoking history of 10 or more pack years; vaping or e-cigarette users must have stopped at least 26 weeks before screening
- Known sensitivity to KT-621 components
- Member of the study team or immediate family
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 17 locations
1
Kymera Investigative Site
Redding, California, United States, 96001
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2
Kymera Investigative Site
Upland, California, United States, 91786
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3
Kymera Investigative Site
Miami, Florida, United States, 33126
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4
Kymera Investigative Site
Miami, Florida, United States, 33173
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5
Kymera Investigative Site
Tampa, Florida, United States, 33607
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6
Kymera Investigative Site
East Point, Georgia, United States, 30344
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7
Kymera Investigative Site
Edmond, Oklahoma, United States, 73034
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8
Kymera Investigative Site
Clackamas, Oregon, United States, 97015
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9
Kymera Investigative Site
Pittsburgh, Pennsylvania, United States, 15241
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10
Kymera Investigative Site
North Charleston, South Carolina, United States, 29406
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11
Kymera Investigative Site
Rock Hill, South Carolina, United States, 29732
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12
Kymera Investigative Site
Chattanooga, Tennessee, United States, 37403
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13
Kymera Investigative Site
McKinney, Texas, United States, 75069
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14
Kymera Investigative Site
Belgrade, Serbia, 11000
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15
Kymera Investigative Site
Kamenitz, Serbia, 21204
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16
Kymera Investigative Site
Užice, Serbia, 31000
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17
Kymera Investigative Site
Bedford, United Kingdom, MK40 2FG
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Research Team
K
Kymera Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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