Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Moderate-to-Severe AD, APG777, Dupilumab, APG990
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of AD that has been present for ≥ 1 year prior to the Screening visit and as determined by the Investigator through participant interview and/or review of the medical history. * Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of ≥ 16, b) vIGA-AD score of ≥ 3, and c) AD affecting ≥10% of body surface area (BSA). * History of inadequate response to treatment with topical medications * Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit.
Exclusion criteria
* Participation in a prior study with APG777 or APG990. * Prior treatment with protocol-specified monoclonal antibodies (mAbs). * Has used any AD-related topical medications within 7 days prior to Baseline visit. * Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit * History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab. * Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments Note: Additional protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentrations (Cmax) of APG990 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | PK parameters will be performed using a non-compartmental approach with a validated PK software. |
| Time to Reach Cmax (tmax) of APG777 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | 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. |
| Maximum Serum Concentrations (Cmax) of APG777 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | PK parameters will be performed using a non-compartmental approach with a validated PK software |
| Predose Serum Concentrations (Ctrough) of APG777 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | PK parameters will be performed using a non-compartmental approach with a validated PK software. |
| Predose Serum Concentrations (Ctrough) of APG990 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | PK parameters will be performed using a non-compartmental approach with a validated PK software. |
| Time to Reach Cmax (tmax) of APG990 | Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24 | 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. |
Countries
Australia, Canada, New Zealand
Outcome results
None listed