This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Oral drug
Oral placebo matched to KT-621
Kymera Investigative Site
Birmingham, Alabama, United States
RECRUITINGKymera Investigative Site
North Little Rock, Arkansas, United States
RECRUITINGKymera Investigative Site
Freemont, California, United States
RECRUITINGKymera Investigative Site
Los Angeles, California, United States
Change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: From baseline through Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From baseline through Week 16, and from Week 16 through Week 68
Incidence of treatment-emergent serious adverse events (SAEs)
Time frame: From baseline through Week 16, and from Week 16 through Week 68
Percentage change from baseline in body surface area (BSA) affected by AD
Time frame: From baseline to Week 16 and to Week 68
Percentage change from baseline in the Peak Pruritus NRS score
Time frame: From baseline to Week 16, and to Week 68
Proportion of participants with at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (NRS)
Time frame: At Week 16 and at Week 68
Proportion of participants who achieve a validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 to 1 (on a 5-point scale) and a reduction from the baseline value of at least 2 points
Time frame: At Week 16 and at Week 68
Proportion of participants with EASI-50, EASI-75, and EASI-90
Time frame: At Week 16 and at Week 68
Percentage change from baseline in the EASI score
Time frame: From baseline to Week 68
Percentage change from baseline in the SCORing Atopic Dermatitis (SCORAD) score
Time frame: From baseline to Week 16, and to Week 68
Change from baseline in the Patient-Oriented Eczema Measure (POEM)
Time frame: From baseline to Week 16, and to Week 68
Change from baseline in the Dermatology Life Quality Index (DLQI)
Time frame: From baseline to Week 16, and to Week 68
Plasma concentration of KT-621 derived from plasma concentration time data
Time frame: From baseline to Week 16, and to Week 68
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Kymera Investigative Site
Los Angeles, California, United States
RECRUITINGKymera Investigative Site
Santa Monica, California, United States
RECRUITINGKymera Investigative Site
Delray Beach, Florida, United States
RECRUITINGKymera Investigative Site
Miami, Florida, United States
RECRUITINGKymera Investigative Site
Miramar, Florida, United States
RECRUITINGKymera Investigative Site
Normal, Illinois, United States
RECRUITING...and 57 more locations