A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma Study

NCT07677059 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: KT621-AS-203
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 2b open-label, long-term extension study is designed to evaluate the long-term safety and efficacy of KT-621 in participants with asthma who were previously enrolled in the parent study (KT621-AS-202) of KT-621 for asthma. The main goals of this study are to investigate the long-term safety and tolerability of KT-621, the long-term efficacy of KT-621 at treating asthma, and how KT-621 behaves in the body long-term.

Conditions

Asthma (Diagnosis)

Keywords

KT-621; STAT6; stat6 degrader; targeted protein degrader; Phase 2; phase 2b; OLE; LTE

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAEs)

  From baseline through Week 52

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

  From baseline through Week 52

Secondary Outcomes (5)

• Change from baseline in pre-bronchodilator FEV1

  From baseline (as assessed in the parent study) to Week 52

• Change from baseline in post-bronchodilator FEV1

  From baseline (as assessed in the parent study) to Week 52

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

  From baseline (as assessed in the parent study) to Week 52

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

  From baseline (as assessed in the parent study) to Week 52

• Plasma concentration of KT-621 derived from plasma concentration time data

  From baseline to Week 52

Study Arms (1)

KT-621

EXPERIMENTAL

Drug: KT-621

Interventions

KT-621 DRUG

Oral drug

KT-621

Eligibility Criteria

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

You may qualify if:

• Must have completed all visits of the parent study, per its protocol, up to the end of treatment (EoT) visit.
• 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.
• Must agree to contraceptive requirements in compliance with the clinical study and local requirements.

You may not qualify if:

• Must not have experienced any clinically significant change in health status during the parent study, which, in the opinion of the Investigator, would interfere with participant safety, study evaluations, or compliance with study procedures; or otherwise make the participant unsuitable for participation in this study.
• Must not have developed an AE during the parent study, that in the opinion of the Investigator or of the Sponsor's Medical Monitor, could indicate that continued treatment may present an unreasonable risk for the participant.
• Must not have met permanent discontinuation criteria and/or permanently discontinued study treatment for any reason during the parent study.
• Must not be a member of the Sponsor or site's investigational team or their immediate family.
• Must not be unsuitable to enter the study for any other reason, as judged by the Investigator, including potential risk of noncompliance to study procedures.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (1)

Kymera Investigative Site

Tampa, Florida, 33607, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kymera Medical Director

CONTACT

857-285-5300; clinicaltrials@kymeratx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)