A Study Evaluating APG777 in Atopic Dermatitis
- Registration Number
- NCT06395948
- Lead Sponsor
- Apogee Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 391
- 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
- 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/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Induction Period: APG777 APG777 Participants will receive APG777 per protocol defined dosing regimen Part A: Maintenance Period: APG777 APG777 Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen Part A: Induction Period: Placebo Placebo Participants will receive matching Placebo injections per protocol defined dosing regimen Part B: Induction Period: Placebo Placebo Participants will receive matching placebo injections per protocol defined dosing regimen Part B: Induction Period: APG777 APG777 Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen Part B: Maintenance Period: APG777 APG777 Participants will receive APG777 per protocol defined dosing regimen
- Primary Outcome Measures
Name Time Method Part A and B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Baseline and at Week 16
- Secondary Outcome Measures
Name Time Method Part A and B: Percent Change from Baseline in EASI Baseline through Week 16 and at Week 52 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: Change from Baseline in EASI Baseline, through Week 16 and at Week 52 Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) Up to 106 Weeks 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: Serum Concentrations of APG777 Over Time Up to 106 Weeks 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: Predose Serum Concentrations of APG777 (Ctrough) Up to 106 Weeks Part A and B: Time to reach Cmax (tmax) Up to 106 Weeks 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: 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: Maximum concentration (Cmax) of APG777 Up to 106 Weeks Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period 16 Weeks to 52 Weeks
Trial Locations
- Locations (87)
Investigational Site #14
🇺🇸Fountain Valley, California, United States
Investigational Site # 46
🇺🇸Los Angeles, California, United States
Investigational Site # 8
🇺🇸San Diego, California, United States
Investigational Site # 44
🇺🇸New Haven, Connecticut, United States
Investigational Site # 1
🇺🇸Coral Gables, Florida, United States
Investigational site #48
🇺🇸Jacksonville, Florida, United States
Investigational Site # 21
🇺🇸Margate, Florida, United States
Investigational site #47
🇺🇸Douglasville, Georgia, United States
Investigational Site # 36
🇺🇸Skokie, Illinois, United States
Investigational Site # 38
🇺🇸West Lafayette, Indiana, United States
Scroll for more (77 remaining)Investigational Site #14🇺🇸Fountain Valley, California, United States