264 Participants NeededMy employer runs this trial

KT-621 for Asthma

(BREADTH-EXT Trial)

Recruiting at 6 trial locations
KM
Overseen ByKymera Medical Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kymera Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called KT-621, a new potential drug, to evaluate its long-term safety and effectiveness for people with asthma. The researchers aim to understand how KT-621 functions in the body and whether it continues to manage asthma symptoms safely. The study specifically targets participants who have completed a previous KT-621 study. Those who finished the earlier study and can attend all visits and tests might find this trial suitable. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Is there any evidence suggesting that KT-621 is likely to be safe for humans?

Research has shown that KT-621 demonstrates promising safety results from earlier studies. In trials with healthy volunteers, participants tolerated KT-621 well, and no major side effects emerged. Participants took KT-621 as a once-a-day pill, and the safety results exceeded expectations. Additionally, tests in asthma models showed KT-621 worked similarly to existing treatments like dupilumab, which is already approved. These findings suggest that KT-621 could be a safe option for those considering joining a clinical trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for asthma, which often include inhaled corticosteroids and bronchodilators, KT-621 works differently by targeting specific pathways involved in the inflammatory response. Researchers are excited about KT-621 because it has a novel mechanism of action that may provide more effective control of asthma symptoms with potentially fewer side effects. This innovative approach could offer new hope for patients who do not respond well to existing therapies.

What evidence suggests that KT-621 might be an effective treatment for asthma?

Research has shown that KT-621, the investigational treatment in this trial, could be a promising option for asthma. In studies with mice, KT-621 not only prevented asthma from worsening but also improved existing symptoms. Early human studies demonstrated a significant reduction in a key asthma marker called FeNO, which measures airway inflammation, by 25% and 33% in different dose groups. KT-621 breaks down a protein called STAT6, involved in allergies and asthma, and proved effective even at low doses. Patients tolerated it well. These findings suggest that KT-621 could be an effective new treatment for asthma.25678

Are You a Good Fit for This Trial?

This trial is for people with asthma who have already taken part in a previous KT-621 asthma study. Only those previously enrolled in that parent study can join.

Inclusion Criteria

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

Exclusion Criteria

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
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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KT-621 to evaluate long-term safety and efficacy

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KT-621

Trial Overview

The study tests the long-term safety and effectiveness of an oral medication called KT-621 for asthma. All participants receive KT-621, and researchers monitor its effects over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: KT-621Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
850+

Citations

Kymera Therapeutics Announces Presentations on KT-621 ...

Additionally, KT-621 also showed early evidence of activity in asthma based on improvement in biomarkers and patient-reported outcome in AD.

Kymera Therapeutics Announces Second Quarter 2025 ...

The new asthma efficacy mouse model data demonstrated both prevention of disease progression as well as reversal of established disease,

KT-621 Drug Profile

Kymera Therapeutics announced they will present P2 Asthma results in 4Q27 for KT-621 Clinical Outcomes Expected. Atopic results in YE26 for KT-621 Clinical ...

Kymera Therapeutics Announces Positive First-in-Human ...

KT-621 could achieve robust STAT6 degradation in blood and. We exceeded our 90% STAT6 degradation target even at single doses as low as 6.25 mg, 63% at Day 14.

Pipeline

KT-621 demonstrated deep STAT6 degradation in blood and skin, patient-reported outcomes in AD and comorbid asthma and allergic rhinitis, and was well tolerated ...

Kymera Therapeutics to Announce KT-621 Phase 1 ...

In preclinical studies, KT-621 demonstrated dupilumab-like activity in several in vitro and in vivo models and was safe and well tolerated. KT- ...

Kymera Therapeutics Presents New Preclinical Data for KT ...

The featured data demonstrate activity of KT-621 comparable to a saturating dose of the IL-4Rα antibody, dupilumab, in an asthma efficacy model ...

New Preclinical Data for KT-621, a First-In-Class, Oral ...

Phase 1 healthy volunteer SAD/MAD data, which will include STAT6 degradation, safety and additional biomarker results. Additionally, the KT-621.