This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
470
Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Baseline and at Week 16
Part B: Proportion of participants who achieve EASI 75 at Week 16
Time frame: At Week 16
Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 106 Weeks
Part A and B: Change from Baseline in EASI
Time frame: Baseline, through Week 16 and at Week 52
Part A and B: Percent Change from Baseline in EASI
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >= 2-Point Reduction
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Proportion of Participants Achieving a >= 4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS)
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS
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Investigational Site
Fountain Valley, California, United States
Investigational Site
Los Angeles, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
New Haven, Connecticut, United States
Investigational Site
Coral Gables, Florida, United States
Investigational Site
Jacksonville, Florida, United States
Investigational Site
Margate, Florida, United States
Investigational Site
Douglasville, Georgia, United States
Investigational Site
Chicago, Illinois, United States
Investigational Site
Skokie, Illinois, United States
...and 84 more locations
Time frame: Baseline through Week 16 and at Week 52
Part A and B: Serum Concentrations of APG777 Over Time
Time frame: Up to 106 Weeks
Part A and B: Predose Serum Concentrations of APG777 (Ctrough)
Time frame: Up to 106 Weeks
Part A and B: Maximum concentration (Cmax) of APG777
Time frame: Up to 106 Weeks
Part A and B: Time to reach Cmax (tmax)
Time frame: Up to 106 Weeks
Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period
Time frame: Baseline to 16 Weeks
Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period
Time frame: 16 Weeks to 52 Weeks