A Study Evaluating APG777 in Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: APG777Drug: Placebo
- 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 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 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
- 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: 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: 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: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period 16 Weeks to 52 Weeks
Trial Locations
- Locations (46)
Investigational Site # 46
馃嚭馃嚫Los Angeles, California, United States
Investigational Site # 44
馃嚭馃嚫New Haven, Connecticut, United States
Investigational Site # 45
馃嚨馃嚤艁贸d藕, 艁贸dzkie, Poland
Investigational Site #14
馃嚭馃嚫Fountain Valley, California, United States
Investigational Site # 8
馃嚭馃嚫San Diego, California, United States
Investigational Site # 1
馃嚭馃嚫Coral Gables, Florida, United States
Investigational Site # 21
馃嚭馃嚫Margate, Florida, United States
Investigational Site # 36
馃嚭馃嚫Skokie, Illinois, United States
Investigational Site # 38
馃嚭馃嚫West Lafayette, Indiana, United States
Investigational Site # 2
馃嚭馃嚫Rockville, Maryland, United States
Investigational Site # 43
馃嚭馃嚫Detroit, Michigan, United States
Investigational Site #10
馃嚭馃嚫Troy, Michigan, United States
Investigational Site #16
馃嚭馃嚫Portsmouth, New Hampshire, United States
Investigational Site # 3
馃嚭馃嚫Wilmington, North Carolina, United States
Investigational Site # 31
馃嚭馃嚫Boardman, Ohio, United States
Investigational Site #12
馃嚭馃嚫Mason, Ohio, United States
Investigational Site #22
馃嚭馃嚫Portland, Oregon, United States
Investigational Site # 34
馃嚭馃嚫Pittsburgh, Pennsylvania, United States
Investigational Site # 37
馃嚭馃嚫Charleston, South Carolina, United States
Investigational Site # 4
馃嚭馃嚫Nashville, Tennessee, United States
Investigational Site # 23
馃嚭馃嚫Dallas, Texas, United States
Investigational Site # 33
馃嚭馃嚫Dallas, Texas, United States
Investigational Site # 18
馃嚭馃嚫San Antonio, Texas, United States
Investigational Site # 5
馃嚭馃嚫Norfolk, Virginia, United States
Investigational Site # 7
馃嚭馃嚫Mill Creek, Washington, United States
Investigational Site # 26
馃嚚馃嚘Calgary, Alberta, Canada
Investigational Site # 32
馃嚚馃嚘Edmonton, Alberta, Canada
Investigational Site #19
馃嚚馃嚘Winnipeg, Manitoba, Canada
Investigational Site #15
馃嚚馃嚘Fredericton, New Brunswick, Canada
Investigational Site # 9
馃嚚馃嚘Markham, Ontario, Canada
Investigational Site # 25
馃嚚馃嚘Mississauga, Ontario, Canada
Investigational Site #13
馃嚚馃嚘Peterborough, Ontario, Canada
Investigational Site # 20
馃嚚馃嚘Toronto, Ontario, Canada
Investigational Site # 24
馃嚚馃嚘Toronto, Ontario, Canada
Investigational Site #11
馃嚚馃嚘Toronto, Ontario, Canada
Investigational Site # 6
馃嚚馃嚘Montreal, Quebec, Canada
Investigational Site #17
馃嚚馃嚘Qu茅bec, Quebec, Canada
Investigational Site # 35
馃嚨馃嚤Wroc艂aw, Dolnoslaskie, Poland
Investigational Site # 39
馃嚨馃嚤Wroc艂aw, Dolnoslaskie, Poland
Investigational Site # 40
馃嚨馃嚤Lublin, Lubelskie, Poland
Investigational Site # 42
馃嚨馃嚤Warsaw, Mazowieckie, Poland
Investigational Site # 27
馃嚨馃嚤Warszawa, Mazowieckie, Poland
Investigational Site # 41
馃嚨馃嚤Gda艅sk, Pomorskie, Poland
Investigational Site # 28
馃嚨馃嚤Katowice, Silesia, Poland
Investigational Site # 29
馃嚨馃嚤Sosnowiec, Silesia, Poland
Investigational Site # 30
馃嚨馃嚤Krak贸w, Woj. Ma艂opolskie, Poland