This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).
This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD. The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
Time frame: Baseline, Week 16
EASI-75 response at Week 16
EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.
Time frame: Baseline, Week 16
Investigator Global Assessment (IGA) response at Week 16
The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe). IGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline
Time frame: Baseline, Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Birmingham, Alabama, United States
RECRUITINGNovartis Investigative Site
Birmingham, Alabama, United States
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Fort Smith, Arkansas, United States
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Fountain Valley, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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