Clinical trial NCT06395948: A Study Evaluating APG777 in Atopic Dermatitis
Official title: A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
APG777
Safety
Efficacy
Lead sponsor: Apogee Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-02
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply.

Primary outcomes:
measure: Part A and B: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Baseline and at Week 16
Secondary outcomes:
measure: Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 106 Weeks
measure: Part A and B: Change from Baseline in EASI
timeFrame: Baseline, through Week 16 and at Week 52
measure: Part A and B: Percent Change from Baseline in EASI
timeFrame: Baseline through Week 16 and at Week 52
measure: Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score
timeFrame: Baseline through Week 16 and at Week 52
measure: 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
timeFrame: Baseline through Week 16 and at Week 52
measure: Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement
timeFrame: Baseline through Week 16 and at Week 52
measure: 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)
timeFrame: Baseline through Week 16 and at Week 52
measure: Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS
timeFrame: Baseline through Week 16 and at Week 52
measure: Part A and B: Serum Concentrations of APG777 Over Time
timeFrame: Up to 106 Weeks
measure: Part A and B: Predose Serum Concentrations of APG777 (Ctrough)
timeFrame: Up to 106 Weeks
measure: Part A and B: Maximum concentration (Cmax) of APG777
timeFrame: Up to 106 Weeks
measure: Part A and B: Time to reach Cmax (tmax)
timeFrame: Up to 106 Weeks
measure: Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period
timeFrame: Baseline to 16 Weeks
measure: Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period
timeFrame: 16 Weeks to 52 Weeks
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Investigational Site #14
state: California
city: Los Angeles
country: United States
facility: Investigational Site # 46
state: California
city: San Diego
country: United States
facility: Investigational Site # 8
state: California
city: New Haven
country: United States
facility: Investigational Site # 44
state: Connecticut
city: Coral Gables
country: United States
facility: Investigational Site # 1
state: Florida
city: Jacksonville
country: United States
facility: Investigational site #48
state: Florida
city: Margate
country: United States
facility: Investigational Site # 21
state: Florida
city: Douglasville
country: United States
facility: Investigational site #47
state: Georgia
city: Skokie
country: United States
facility: Investigational Site # 36
state: Illinois
city: West Lafayette
country: United States
facility: Investigational Site # 38
state: Indiana
city: Bowling Green
country: United States
facility: Investigational site #50
state: Kentucky
city: Rockville
country: United States
facility: Investigational Site # 2
state: Maryland
city: Detroit
country: United States
facility: Investigational Site # 43
state: Michigan
city: Troy
country: United States
facility: Investigational Site #10
state: Michigan
city: Portsmouth
country: United States
facility: Investigational Site #16
state: New Hampshire
city: New York
country: United States
facility: Investigational site #49
state: New York
city: Wilmington
country: United States
facility: Investigational Site # 3
state: North Carolina
city: Boardman
country: United States
facility: Investigational Site # 31
state: Ohio
city: Mason
country: United States
facility: Investigational Site #12
state: Ohio
city: Portland
country: United States
facility: Investigational Site #22
state: Oregon
city: Pittsburgh
country: United States
facility: Investigational Site # 34
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site # 37
state: South Carolina
city: Nashville
country: United States
facility: Investigational Site # 4
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site # 23
state: Texas
city: Dallas
country: United States
facility: Investigational Site # 33
state: Texas
city: San Antonio
country: United States
facility: Investigational Site # 18
state: Texas
city: Norfolk
country: United States
facility: Investigational Site # 5
state: Virginia
city: Mill Creek
country: United States
facility: Investigational Site # 7
state: Washington
city: Calgary
country: Canada
facility: Investigational Site # 26
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site #51
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site # 32
state: Alberta
city: Vancouver
country: Canada
facility: Investigational site #73
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigational Site #19
state: Manitoba
city: Fredericton
country: Canada
facility: Investigational Site #15
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational site #52
state: Ontario
city: Markham
country: Canada
facility: Investigational Site # 9
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site # 25
state: Ontario
city: Ottawa
country: Canada
facility: Investigational site #53
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site #13
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site # 20
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site # 24
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site #11
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site # 6
state: Quebec
city: Québec
country: Canada
facility: Investigational Site #17
state: Quebec
city: Prague
country: Czechia
facility: Investigational site #54
city: Prague
country: Czechia
facility: Investigational site #59
city: Prague
country: Czechia
facility: Investigational site #57
city: Rouen
country: France
facility: Investigational site #80
state: Normandie
city: Tuebingen
country: Germany
facility: Investigational site #63
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Investigational site #76
state: Bavaria
city: München
country: Germany
facility: Investigational site #62
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Investigational site #58
state: Brandenburg
city: Darmstadt
country: Germany
facility: Investigational site #61
state: Hessen
city: Frankfurt
country: Germany
facility: Investigational site #65
state: Hesse
city: Bad Bentheim
country: Germany
facility: Investigational site #74
state: Lower Saxony
city: Münster
country: Germany
facility: Investigational site #79
state: North Rhine Westfalia
city: Dresden
country: Germany
facility: Investigational site #78
state: Saxony
city: Kiel
country: Germany
facility: Investigational site #75
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: Investigational site #64
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Investigational site #60
city: Hamburg
country: Germany
facility: Investigational site #55
city: Debrecen
country: Hungary
facility: Investigational site #72
state: Hajdú-Bihar
city: Wrocław
country: Poland
facility: Investigational Site # 35
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Investigational Site # 39
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Investigational Site # 40
state: Lubelskie
city: Warsaw
country: Poland
facility: Investigational Site # 42
state: Mazowieckie
city: Warszawa
country: Poland
facility: Investigational Site # 27
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Investigational Site # 41
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site # 28
state: Silesia
city: Sosnowiec
country: Poland
facility: Investigational Site # 29
state: Silesia
city: Kraków
country: Poland
facility: Investigational Site # 30
state: Woj. Małopolskie
city: Szczecin
country: Poland
facility: Investigational site #56
state: Zachodniopomorskie
city: Łódź
country: Poland
facility: Investigational Site # 45
state: Łódzkie
city: Santiago De Compostela
country: Spain
facility: Investigational site #66
state: A Coruña
city: Badalona
country: Spain
facility: Investigational site #71
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Investigational site #68
state: Islas Canarias
city: Alicante
country: Spain
facility: Investigational site #70
city: Madrid
country: Spain
facility: Investigational site #69
city: Madrid
country: Spain
facility: Investigational site #67
city: Zaragoza
country: Spain
facility: Investigational site #77
Study officials:
References: