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Looking for participantsPhase2

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

Sponsor: Kymera Therapeutics, Inc.

NCT ID: NCT07323654

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
KT-621 (drug), Placebo (other)
How long the study runs
Study runs about 23 months (dates as stated)
About the drug or intervention
KT-621 — drug: Oral drug · Placebo — other: Oral placebo matched to KT-621
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a tablet called KT-621, taken by mouth, in adults aged 18 to 75 with moderate to severe eosinophilic asthma. Eosinophilic asthma is a type of asthma linked to higher levels of a white blood cell called eosinophils. The study is funded by Kymera Therapeutics, Inc.

Who can take part

  • You are 18 to 75 years old.
  • A doctor diagnosed you with asthma at least 1 year ago.
  • You have been taking a steady dose of a medium or high dose inhaled corticosteroid (ICS) combined with a long-acting β2-agonist (LABA) inhaler, with no dose change for at least 4 weeks before screening.
  • Your breathing test (FEV1, how much air you can blow out in one second) is 40 to 80% of the expected value before screening and before starting.
  • Your asthma symptom score (ACQ-5) is 1.5 or higher.
  • Your FeNO level (a breath test showing airway inflammation) is 25 parts per billion or higher.
  • Your breathing improves after an inhaler (salbutamol) given at screening, showing reversible airway narrowing.
  • Your blood eosinophil count is 0.30 × 10^9/L or higher.
  • You have had at least 1 asthma flare-up in the past 52 weeks that needed steroid tablets or injections, a hospital stay, or an urgent care visit.
  • You agree to follow the contraception rules of the study.
  • You are willing and able to attend visits, follow the treatment plan, have tests, and complete an electronic diary.

Who may not be able to

  • You have another significant lung disease besides asthma.
  • You had an asthma flare-up needing steroid tablets or injections, a hospital stay, or an urgent care visit in the 4 weeks before screening up to the start of the study.
  • You have another significant illness or condition that the study doctor thinks could affect your safety or the study results.
  • You are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  • Your screening blood or laboratory tests are outside the normal range.
  • You have taken an experimental drug or device in another study within the last 8 weeks or 5 half-lives (whichever is longer).
  • You have any condition that might stop you following the study plan.
  • You currently smoke (including nicotine-free products or vaping, including e-cigarettes), or you have smoked 10 pack years or more. Former smokers with less than 10 pack years and people who vaped must have stopped at least 26 weeks before screening.
  • You know you are sensitive or allergic to any ingredient in KT-621.
  • You are part of the study team or a close family member of someone on the study team.

What taking part involves

  • • Taking KT-621 as a tablet by mouth.
  • • Keeping to your regular asthma inhalers at a steady dose.
  • • Attending study visits, having laboratory tests and other study procedures.
  • • Completing questionnaires and an electronic diary.

Time commitment: Not stated — ask the trial team, as the number of visits, total study duration, and how long you take KT-621 are not given in the data above.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
264
Started
2026-01-28
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for eosinophilic asthma
  • • Phase2 - 264 participants
  • • This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with eosinophilic asthma

Where?

  • • Bedford - Kymera Investigative Site
  • • Birmingham - Kymera Investigative Site
  • • Bristol - Kymera Investigative Site
  • • Leicester - Kymera Investigative Site
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Eosinophilic Asthma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a physician diagnosis of asthma for at least 1 year
  • ✓ a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits,
  • ✓ an ACQ-5 score ≥ 1
  • ✓ a FeNO level of ≥ 25 ppb at the Screening and Baseline visits

What the study is looking for

  • ✓Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75...
  • ✓Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.
  • ✓Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to...
  • ✓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.

Who cannot take part

  • ✗Must not have any clinically significant lung disease other than asthma.
  • ✗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...
  • ✗Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct...
See the full 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 Is This Study? (6 UK sites)

Kymera Investigative Site

Bedford MK40 2FG, United Kingdom

Recruiting

Kymera Investigative Site

Birmingham, United Kingdom

Recruiting

Kymera Investigative Site

Bristol, United Kingdom

Recruiting

Kymera Investigative Site

Leicester, United Kingdom

Recruiting

Kymera Investigative Site

London, United Kingdom

Recruiting

Kymera Investigative Site

Wythenshawe, United Kingdom

Recruiting

How to Get in Touch

Kymera Medical Director

Sponsor contact

CONTACT

857-285-5300 clinicaltrials@kymeratx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01