Recruiting

Phase 2

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

Sponsor:

Kymera Therapeutics, Inc.

Code:

NCT07323654

Conditions

Eosinophilic Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KT-621

Placebo

Study Details

Brief summary:

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

Eosinophilic Asthma

Study ID

NCT07323654

Start date

Jan 28, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: KT-621 Dose 1

experimental: Group 2: KT-621 Dose 2

experimental: Group 3: KT-621 Dose 3

placebo comparator: Group 4: Placebo

Interventions

KT-621

Oral drug

Placebo

Oral placebo matched to KT-621

Primary outcome measure

Change from baseline in pre-bronchodilator FEV1 [ Time Frame: From baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Kymera Medical Director

857-285-5300 clinicaltrials@kymeratx.com

Locations

Kymera Investigative Site

Recruiting

Lancaster, California, United States, 93534

Kymera Investigative Site

Recruiting

Long Beach, California, United States, 90815

Kymera Investigative Site

Recruiting

Northridge, California, United States, 91324

Kymera Investigative Site

Recruiting

Redding, California, United States, 96001

Kymera Investigative Site

Recruiting

San Francisco, California, United States, 94112

Kymera Investigative Site

Recruiting

Upland, California, United States, 91786

Kymera Investigative Site

Recruiting

Aurora, Colorado, United States, 80045

Kymera Investigative Site

Recruiting

New Haven, Connecticut, United States, 06519

Kymera Investigative Site

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Kymera Investigative Site

Recruiting

Miami, Florida, United States, 33126

Kymera Investigative Site

Recruiting

Miami, Florida, United States, 33173

Kymera Investigative Site

Recruiting

Miami Lakes, Florida, United States, 33014

Kymera Investigative Site

Recruiting

Orlando, Florida, United States, 32819

Kymera Investigative Site

Recruiting

Tampa, Florida, United States, 33607

Kymera Investigative Site

Recruiting

East Point, Georgia, United States, 30344

Kymera Investigative Site

Recruiting

Iowa City, Iowa, United States, 52242

Kymera Investigative Site

Recruiting

Kansas City, Kansas, United States, 66160

Kymera Investigative Site

Recruiting

Louisville, Kentucky, United States, 40217

Kymera Investigative Site

Recruiting

Boston, Massachusetts, United States, 02114

Kymera Investigative Site

Recruiting

Chapel Hill, North Carolina, United States, 27517

Kymera Investigative Site

Recruiting

Durham, North Carolina, United States, 27705

Kymera Investigative Site

Recruiting

Toledo, Ohio, United States, 43617

Kymera Investigative Site

Recruiting

Edmond, Oklahoma, United States, 73034

Kymera Investigative Site

Recruiting

Clackamas, Oregon, United States, 97015

Kymera Investigative Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Kymera Investigative Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Kymera Investigative Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15241

Kymera Investigative Site

Recruiting

North Charleston, South Carolina, United States, 29406

Kymera Investigative Site

Recruiting

Rock Hill, South Carolina, United States, 29732

Kymera Investigative Site

Recruiting

Chattanooga, Tennessee, United States, 37403

Kymera Investigative Site

Recruiting

Dallas, Texas, United States, 75209

Kymera Investigative Site

Recruiting

Dallas, Texas, United States, 75246

Kymera Investigative Site

Recruiting

McKinney, Texas, United States, 75069

Kymera Investigative Site

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Kymera Therapeutics, Inc.

Last update posted

Aug 17, 2026

Last verified

Jan, 2026

Keywords

kt-621
stat6 degrader
stat6
targeted protein degrader
Phase 2
phase 2b

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kymera Therapeutics, Inc. on 2026-08-17.