A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
Kymera Therapeutics, Inc.
Summary
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.
Eligibility
- Age range
- 12–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must be 12 to 75 years of age, inclusive, at the time of signing the IAF (informed assent form) and/or ICF (informed consent form). * Must have chronic AD that has been present for at least 3 years (for participants ≥ 18 years of age) or 1 year (for participants \< 18 years of age) before the Screening visit. * Must have an EASI score ≥ 16 at the Screening and Baseline visits. * Must have a vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits. * Must have at least 10% BSA of AD involvement at the Screening and Baseline visits. * Must have a weekly ave…
Interventions
- DrugKT-621
Oral drug
- OtherPlacebo
Oral placebo matched to KT-621
Locations (61)
- Kymera Investigative SiteBirmingham, Alabama
- Kymera Investigative SiteNorth Little Rock, Arkansas
- Kymera Investigative SiteFreemont, California
- Kymera Investigative SiteLos Angeles, California
- Kymera Investigative SiteLos Angeles, California
- Kymera Investigative SiteSanta Monica, California