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Kymera (BREADTH) Moderate to Severe Asthma Study
If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.
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- Kymera (BREADTH) Moderate to Severe Asthma Study
KYMERA (BREADTH) AGES 18 TO 75 YEARS (MODERATE TO SEVERE ASTHMA STUDY)
- The primary objective of this study (KT621-AS-202) is to evaluate the efficacy of KT-621 compared to placebo in participants with uncontrolled moderate to severe eosinophilic asthma.
- As the first-in-class oral STAT6 degrader, KT-621 represents a novel and potentially transformative therapeutic approach for the treatment of eosinophilic asthma by blocking IL-4 and IL-13 signaling pathways, which drive airway inflammation. Randomized participants are to receive 1 of 3 once daily (QD) doses of KT-621.
- The screening period will last approximately 4 weeks, with a minimum duration of 21 days to ensure that background asthma controller medications are stable prior to initial administration of study drug, 12-week treatment period, and 4-week safety follow-up period.
- Following this, participants may be eligible to enroll in a 52-week open-label extension (OLE) study (KT621-AS-203) assessing the long-term effects of KT-621.
Key Inclusion Criteria:
- 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 ≥ 52 weeks prior to screening visit.
- Must be on a regimen of medium- to high-dose ICS, defined as ≥ 500 µg fluticasone propionate dry powder formulation or an equivalent total daily dose, in combination with a LABA, used for at least 12 weeks prior to the Screening visit.
Key Exclusion Criteria:
- The presence of any clinically significant pulmonary disease other than asthma.
- Current smokers of nicotine/tobacco products, participants with smoking history of ≥ 10 pack years, and participants using 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 randomization.
Interested in This Research Study?
If you’d like to learn more or see whether you may be eligible to participate, please complete the brief interest form below. A member of our research team will follow up with next steps.
Research Study Interest Form
To learn more or express interest in this study, please complete the form below or contact our research team at 502-368-0732.