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

NCT07323654 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: KT621-AS-202
• Study Type: interventional
• Target: 264
• Locations: 3 countries
• Sites: 17

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pre-bronchodilator FEV1

  From baseline to Week 12

Secondary Outcomes (6)

• Change from baseline in post-bronchodilator FEV1

  From baseline to Week 12

• Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score

  From baseline to Week 12

• Change from baseline in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Global Score

  From baseline to Week 12

• Incidence of treatment-emergent adverse events (TEAEs)

  From baseline through Week 16

• Incidence of treatment-emergent serious adverse events (SAEs)

  From baseline through Week 16

Study Arms (4)

Group 1: KT-621 Dose 1

EXPERIMENTAL

Drug: KT-621

Group 2: KT-621 Dose 2

EXPERIMENTAL

Drug: KT-621

Group 3: KT-621 Dose 3

EXPERIMENTAL

Drug: KT-621

Group 4: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KT-621 DRUG

Oral drug

Group 1: KT-621 Dose 1; Group 2: KT-621 Dose 2; Group 3: KT-621 Dose 3

Placebo OTHER

Oral placebo matched to KT-621

Group 4: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (17)

Kymera Investigative Site

Redding, California, 96001, United States

RECRUITING

Kymera Investigative Site

Upland, California, 91786, United States

RECRUITING

Kymera Investigative Site

Miami, Florida, 33126, United States

RECRUITING

Kymera Investigative Site

Miami, Florida, 33173, United States

RECRUITING

Kymera Investigative Site

Tampa, Florida, 33607, United States

RECRUITING

Kymera Investigative Site

East Point, Georgia, 30344, United States

RECRUITING

Kymera Investigative Site

Edmond, Oklahoma, 73034, United States

RECRUITING

Kymera Investigative Site

Clackamas, Oregon, 97015, United States

RECRUITING

Kymera Investigative Site

Pittsburgh, Pennsylvania, 15241, United States

RECRUITING

Kymera Investigative Site

North Charleston, South Carolina, 29406, United States

RECRUITING

Kymera Investigative Site

Rock Hill, South Carolina, 29732, United States

RECRUITING

Kymera Investigative Site

Chattanooga, Tennessee, 37403, United States

RECRUITING

Kymera Investigative Site

McKinney, Texas, 75069, United States

RECRUITING

Kymera Investigative Site

Belgrade, 11000, Serbia

RECRUITING

Kymera Investigative Site

Kamenitz, 21204, Serbia

RECRUITING

Kymera Investigative Site

Užice, 31000, Serbia

RECRUITING

Kymera Investigative Site

Bedford, MK40 2FG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kymera Medical Director

CONTACT

857-285-5300; clinicaltrials@kymeratx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 7, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); SE (3); GB (1)