Oral KT-621 for adults with moderate to severe eosinophilic asthma
Official title: 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
Run by Kymera Therapeutics, Inc. · NCT07323654 · Data updated 2026-11-12
This study will test whether an oral medicine called KT-621 can help adults with uncontrolled moderate to severe eosinophilic asthma and is safe and tolerable.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 264 (estimated) |
| Sponsor | Kymera Therapeutics, Inc. Industry-sponsored |
| Locations | 81 sites (Lancaster, California and 80 other locations) |
| Status | Recruiting |
| Started | January 28, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07323654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years old with physician-diagnosed moderate to severe eosinophilic asthma that remains uncontrolled despite stable medium-to-high dose ICS/LABA therapy and who meet the required biomarker and lung function thresholds are ideal candidates.
✕Probably not a fit
Patients with well-controlled asthma, non-eosinophilic asthma phenotypes, or those who do not meet the required biomarker or lung function criteria (for example low FeNO or ACQ-5 < 1.5) are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2b interventional trial compares oral KT-621 to placebo in adults with uncontrolled moderate to severe eosinophilic asthma. Participants remain on a stable medium-to-high dose inhaled corticosteroid plus long-acting beta-agonist regimen and must meet lung function and biomarker criteria (pre-bronchodilator FEV1 40–80% predicted, ACQ-5 ≥1.5, FeNO ≥25 ppb). The study will collect safety, tolerability, efficacy, and pharmacokinetic data during the treatment period. Sites are run by Kymera Therapeutics at investigational sites in California and Florida.
Why it matters
Potential benefit: If successful, KT-621 could reduce symptoms and exacerbations and improve lung function in adults with eosinophilic asthma through a novel STAT6-targeting mechanism.
How similar studies have gone: Targeted STAT6 degradation is a novel approach with limited clinical experience to date, although other eosinophil-targeting therapies such as anti–IL-5 agents have demonstrated benefit in similar populations.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Kymera Investigative Site
Lancaster, California, United States Recruiting -
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Long Beach, California, United States Recruiting -
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Northridge, California, United States Recruiting -
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Redding, California, United States Recruiting -
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San Francisco, California, United States Recruiting -
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Upland, California, United States Recruiting
Show 44 more locations
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Aurora, Colorado, United States Recruiting -
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New Haven, Connecticut, United States Recruiting -
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Loxahatchee Groves, Florida, United States Recruiting -
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Miami, Florida, United States Recruiting -
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Miami, Florida, United States Recruiting -
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Miami Lakes, Florida, United States Recruiting -
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Orlando, Florida, United States Recruiting -
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Tampa, Florida, United States Recruiting -
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East Point, Georgia, United States Recruiting -
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Iowa City, Iowa, United States Recruiting -
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Kansas City, Kansas, United States Recruiting -
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Louisville, Kentucky, United States Recruiting -
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Boston, Massachusetts, United States Recruiting -
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Chapel Hill, North Carolina, United States Recruiting -
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Durham, North Carolina, United States Recruiting -
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Toledo, Ohio, United States Recruiting -
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Edmond, Oklahoma, United States Recruiting -
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Clackamas, Oregon, United States Recruiting -
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Philadelphia, Pennsylvania, United States Recruiting -
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Pittsburgh, Pennsylvania, United States Recruiting -
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North Charleston, South Carolina, United States Recruiting -
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Rock Hill, South Carolina, United States Recruiting -
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Chattanooga, Tennessee, United States Recruiting -
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Dallas, Texas, United States Recruiting -
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Dallas, Texas, United States Recruiting -
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McKinney, Texas, United States Recruiting -
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Madison, Wisconsin, United States Recruiting -
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Buenos Aires, Argentina Recruiting -
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Concepción del Uruguay, Argentina Recruiting -
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Lobos, Argentina Recruiting -
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Mar del Plata, Argentina Recruiting -
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Quilmes, Argentina Recruiting -
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Rosario, Argentina Recruiting -
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San Miguel de Tucumán, Argentina Recruiting -
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Vienna, Austria Recruiting -
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Brussels, Belgium Recruiting -
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Erpent, Belgium Recruiting -
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Ghent, Belgium Recruiting -
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Liège, Belgium Recruiting -
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Berlin, Germany Recruiting -
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Leipzig, Germany Recruiting -
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Rome, Italy Recruiting -
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Bialystok, Poland Recruiting
+31 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Kymera Medical Director
- Email: clinicaltrials@kymeratx.com
- Phone: 857-285-5300
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Registry of patients with eosinophilia affecting the respiratory system
This study is gathering information from patients with eosinophilic lung diseases to better understand how their blood eosinophil levels relate to their breathing problems and overall health.
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Real-world benralizumab treatment for adults with severe eosinophilic asthma in Italy
This study will test whether benralizumab helps adults with severe eosinophilic asthma reach partial or complete clinical remission during routine care in Italy.
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Real-world use of benralizumab in Chinese patients with severe eosinophilic asthma
See how benralizumab works for people in China aged 12 and up with severe eosinophilic asthma when given as part of routine care.
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Long-term safety and benefits of SHR-1703 for adults with eosinophilic asthma
This research will test whether regular SHR-1703 injections are safe over the long term and help control symptoms in adults with eosinophilic asthma who remain symptomatic despite medium- to high-dose inhaled steroids.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.