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: 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 (64)
Investigational site #55
π©πͺHamburg, Germany
Investigational site #60
π©πͺBerlin, Germany
Investigational site #52
π¨π¦Ajax, Ontario, Canada
Investigational site #53
π¨π¦Ottawa, Ontario, Canada
Investigational site #54
π¨πΏPrague, Czechia
Investigational site #59
π¨πΏPrague, Czechia
Investigational site #57
π¨πΏPrague, Czechia
Investigational site #63
π©πͺTuebingen, Baden-WΓΌrttemberg, Germany
Investigational site #62
π©πͺMΓΌnchen, Bayern, Germany
Investigational site #58
π©πͺBlankenfelde-Mahlow, Brandenburg, Germany
Investigational site #61
π©πͺDarmstadt, Hessen, Germany
Investigational site #64
π©πͺLuebeck, Schleswig-Holstein, Germany
Investigational site #56
π΅π±Szczecin, Zachodniopomorskie, Poland
Investigational Site #14
πΊπΈFountain Valley, California, United States
Investigational Site # 46
πΊπΈLos Angeles, California, United States
Investigational Site # 8
πΊπΈSan Diego, California, United States
Investigational Site # 44
πΊπΈNew Haven, Connecticut, United States
Investigational Site # 1
πΊπΈCoral Gables, Florida, United States
Investigational site #48
πΊπΈJacksonville, Florida, United States
Investigational Site # 21
πΊπΈMargate, Florida, United States
Investigational site #47
πΊπΈDouglasville, Georgia, United States
Investigational Site # 36
πΊπΈSkokie, Illinois, United States
Investigational Site # 38
πΊπΈWest Lafayette, Indiana, United States
Investigational site #50
πΊπΈBowling Green, Kentucky, United States
Investigational Site # 2
πΊπΈRockville, Maryland, United States
Investigational Site # 43
πΊπΈDetroit, Michigan, United States
Investigational Site #10
πΊπΈTroy, Michigan, United States
Investigational Site #16
πΊπΈPortsmouth, New Hampshire, United States
Investigational site #49
πΊπΈNew York, New York, United States
Investigational Site # 3
πΊπΈWilmington, North Carolina, United States
Investigational Site # 31
πΊπΈBoardman, Ohio, United States
Investigational Site #12
πΊπΈMason, Ohio, United States
Investigational Site #22
πΊπΈPortland, Oregon, United States
Investigational Site # 34
πΊπΈPittsburgh, Pennsylvania, United States
Investigational Site # 37
πΊπΈCharleston, South Carolina, United States
Investigational Site # 32
π¨π¦Edmonton, Alberta, Canada
Investigational Site # 9
π¨π¦Markham, Ontario, Canada
Investigational Site # 4
πΊπΈNashville, Tennessee, United States
Investigational Site # 23
πΊπΈDallas, Texas, United States
Investigational Site # 33
πΊπΈDallas, Texas, United States
Investigational Site # 18
πΊπΈSan Antonio, Texas, United States
Investigational Site # 5
πΊπΈNorfolk, Virginia, United States
Investigational Site # 7
πΊπΈMill Creek, Washington, United States
Investigational Site # 26
π¨π¦Calgary, Alberta, Canada
Investigational Site #51
π¨π¦Calgary, Alberta, Canada
Investigational Site #19
π¨π¦Winnipeg, Manitoba, Canada
Investigational Site #15
π¨π¦Fredericton, New Brunswick, Canada
Investigational Site # 25
π¨π¦Mississauga, Ontario, Canada
Investigational Site #13
π¨π¦Peterborough, Ontario, Canada
Investigational Site # 20
π¨π¦Toronto, Ontario, Canada
Investigational Site # 24
π¨π¦Toronto, Ontario, Canada
Investigational Site #11
π¨π¦Toronto, Ontario, Canada
Investigational Site # 6
π¨π¦Montreal, Quebec, Canada
Investigational Site #17
π¨π¦QuΓ©bec, Quebec, Canada
Investigational Site # 35
π΅π±WrocΕaw, Dolnoslaskie, Poland
Investigational Site # 39
π΅π±WrocΕaw, Dolnoslaskie, Poland
Investigational Site # 40
π΅π±Lublin, Lubelskie, Poland
Investigational Site # 42
π΅π±Warsaw, Mazowieckie, Poland
Investigational Site # 27
π΅π±Warszawa, Mazowieckie, Poland
Investigational Site # 41
π΅π±GdaΕsk, Pomorskie, Poland
Investigational Site # 28
π΅π±Katowice, Silesia, Poland
Investigational Site # 29
π΅π±Sosnowiec, Silesia, Poland
Investigational Site # 30
π΅π±KrakΓ³w, Woj. MaΕopolskie, Poland
Investigational Site # 45
π΅π±ΕΓ³dΕΊ, ΕΓ³dzkie, Poland