The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).
Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Investigational Site
Darlinghurst, New South Wales, Australia
Investigational Site
Kogarah, New South Wales, Australia
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks
Predose Serum Concentrations (Ctrough) of APG777
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Predose Serum Concentrations (Ctrough) of APG990
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG777
PK parameters will be performed using a non-compartmental approach with a validated PK software
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Maximum Serum Concentrations (Cmax) of APG990
PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG777
PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Time to Reach Cmax (tmax) of APG990
PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
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Investigational Site
Westmead, New South Wales, Australia
Investigational Site
Woolloongabba, Queensland, Australia
Investigational Site
Carlton, Victoria, Australia
Investigational Site
East Melbourne, Victoria, Australia
Investigational Site
Mitcham, Victoria, Australia
Investigational Site
Parkville, Victoria, Australia
Investigational Site
Fremantle, Western Australia, Australia
Investigational Site
London, Ontario, Canada
...and 10 more locations
Time frame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24