KT-621 for Asthma
(BREADTH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called KT-621 for individuals with hard-to-control moderate to severe eosinophilic asthma, characterized by high levels of a specific white blood cell. Researchers aim to evaluate KT-621's efficacy and its interaction with the body. Participants will receive one of three different doses of KT-621 or a placebo (a treatment with no active drug) for comparison. This trial may suit those diagnosed with asthma for over a year who continue to experience frequent attacks despite a stable medication regimen. As a Phase 2 trial, it focuses on assessing KT-621's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant research.
Do I need to stop taking my current medications for the trial?
You need to stay on your current asthma medications, including inhaled corticosteroids and long-acting β2-agonists, at a stable dose for the trial. The protocol does not specify stopping other medications, so check with the study team for guidance.
Is there any evidence suggesting that KT-621 is likely to be safe for humans?
Research has shown that KT-621 is generally safe for people. In earlier studies, KT-621's safety profile was similar to a placebo, indicating it didn't cause serious side effects. Most participants experienced only mild issues, if any. Other studies found no unexpected safety problems or harmful effects, even at higher doses. This suggests that KT-621 is safe and doesn't cause severe problems at the doses tested.12345
Why do researchers think this study treatment might be promising for asthma?
Researchers are excited about KT-621 for asthma because it promises a new approach to treatment. While most asthma treatments, like inhaled corticosteroids and bronchodilators, focus on reducing inflammation or relaxing airways, KT-621 may target specific pathways involved in asthma symptoms, potentially offering more precise control of the condition. By exploring different doses, researchers aim to find the most effective and safest option, which could lead to better management of asthma with potentially fewer side effects. This innovative approach could change how asthma is treated, offering new hope for those who struggle with current therapies.
What evidence suggests that KT-621 could be an effective treatment for asthma?
Research has shown that KT-621 holds promise for treating uncontrolled moderate to severe eosinophilic asthma. In earlier studies, KT-621 significantly reduced a protein called STAT6, which is linked to inflammation, by up to 98%. Lower levels of STAT6 can lead to less inflammation in asthma. Additionally, KT-621 demonstrated strong reductions in certain chemicals in the body, known as Type 2 cytokines, which contribute to asthma symptoms. These findings suggest that KT-621 might effectively help manage asthma by targeting the underlying inflammation. Participants in this trial will receive one of three different doses of KT-621 or a placebo to evaluate its effectiveness and safety.12567
Are You a Good Fit for This Trial?
Adults aged 18-75 with a physician's diagnosis of asthma for at least one year, currently on a stable regimen of medium to high-dose inhaled corticosteroids and long-acting β2-agonists. Participants must have moderate to severe eosinophilic asthma, as indicated by specific breathing tests and blood eosinophil counts. They should have had an asthma exacerbation within the last year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KT-621 or placebo to evaluate efficacy and safety in treating uncontrolled moderate to severe eosinophilic asthma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KT-621
- Placebo
Trial Overview
The trial is testing KT-621 against a placebo in adults with uncontrolled moderate to severe eosinophilic asthma. It aims to assess how well KT-621 works, its safety, tolerability, and behavior in the body over time compared to no active treatment.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kymera Therapeutics, Inc.
Lead Sponsor
Citations
1.
investors.kymeratx.com
investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-positive-results-broaden-phase-1bRelease Details
KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin ...
A Study of KT-621 Administered Orally to Adult Participants ...
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 ...
3.
investors.kymeratx.com
investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-outlines-key-2026-objectives-and-strategyRelease Details
After 28 days of daily dosing, KT-621 demonstrated deep STAT6 degradation in blood and skin, robust reductions in disease-relevant Type 2 ...
Kymera Therapeutics Announces U.S. FDA Fast Track ...
The KT-621 BROADEN2 Phase 2b trial in moderate to severe AD patients is ongoing, with data expected to be reported by mid-2027. The BREADTH ...
KT-621 Produces 98% STAT6 Degradation in AD Patients
Kymera Therapeutics reveals promising phase 1b results for KT-621, an oral STAT6 degrader, showing significant effects in moderate to severe ...
252 Safety, Pharmacokinetics and Pharmacodynamics of ...
KT-621 was well tolerated with a safety profile undifferentiated from placebo. There were no serious or severe adverse events (AEs), very few treatment ...
7.
investors.kymeratx.com
investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-new-preclinical-data-kt-621-first-0Kymera Therapeutics Presents New Preclinical Data for KT ...
In preclinical studies, KT-621 demonstrated dupilumab-like activity in several in vitro and in vivo models and was safe and well tolerated. KT- ...
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