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

ConditionAsthma (Diagnosis)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKymera Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • KT-621

    Drug

    Oral drug

Treatment groups

264 Participants
are divided into 1 treatment group
Group A: KT-621Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

Time frame
From baseline through Week 52
2

Incidence of treatment-emergent serious adverse events (SAEs)

Time frame
From baseline through Week 52

Secondary outcomes

1

Change from baseline in pre-bronchodilator FEV1

Time frame
From baseline (as assessed in the parent study) to Week 52
2

Change from baseline in post-bronchodilator FEV1

Time frame
From baseline (as assessed in the parent study) to Week 52
3

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

Time frame
From baseline (as assessed in the parent study) to Week 52
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kymera Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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