Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, APG777, Safety, Efficacy
Brief summary
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.
Interventions
DRUGAPG777
APG777 subcutaneous injection
DRUGPlacebo
Matching placebo subcutaneous injection
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Sponsor's study staff will also be blinded in the study.
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 * Moderate-to-severe AD at Screening and Baseline visits * History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable * Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for \>=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits. * Have completed itch questionnaires in the electronic diary for \>=4 of 7 days prior to Baseline visit
Exclusion criteria
* Participation in a prior study with APG777. * 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 Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) | Baseline and at Week 16 |
| Part B: Proportion of participants who achieve EASI 75 at Week 16 | At Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 106 Weeks |
| Part A and B: Change from Baseline in EASI | Baseline, through Week 16 and at Week 52 |
| Part A and B: Percent Change from Baseline in EASI | Baseline through Week 16 and at Week 52 |
| Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score | 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 | Baseline through Week 16 and at Week 52 |
| Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement | 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) | 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 | Baseline through Week 16 and at Week 52 |
| Part A and B: Serum Concentrations of APG777 Over Time | Up to 106 Weeks |
| Part A and B: Predose Serum Concentrations of APG777 (Ctrough) | Up to 106 Weeks |
| Part A and B: Maximum concentration (Cmax) of APG777 | Up to 106 Weeks |
| Part A and B: Time to reach Cmax (tmax) | 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 | Baseline to 16 Weeks |
| Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period | 16 Weeks to 52 Weeks |
Countries
Canada, Czechia, France, Germany, Hungary, Poland, Spain, United Kingdom, United States
Outcome results
None listed