The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
405
Mean percent change from baseline in EASI at Week 24
Time frame: Baseline, Week 24
Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24
Time frame: Baseline, Week 24
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24
Time frame: Baseline, Week 24
Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24
Time frame: Baseline, Week 24
Incidence and severity of TEAE including treatment-emergent SAEs
Time frame: Baseline, End of Study
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Inmagene Site 1
Lancaster, California, United States
RECRUITINGInmagene Site 23
Los Angeles, California, United States
RECRUITINGInmagene Site 19
Ocala, Florida, United States
RECRUITINGInmagene Site 4
Tampa, Florida, United States
RECRUITINGInmagene Site 2
Rolling Meadows, Illinois, United States
RECRUITINGInmagene Site 6
Kew Gardens, New York, United States
RECRUITINGInmagene Site 21
New York, New York, United States
RECRUITINGInmagene Site 11
Woodbury, New York, United States
RECRUITINGInmagene Site 20
Charlotte, North Carolina, United States
RECRUITINGInmagene Site 10
Fargo, North Dakota, United States
RECRUITING...and 20 more locations