Clinical trial NCT07003425: A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Official title: A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
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: 2025-06-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).

The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.

This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.


Eligibility criteria: Inclusion Criteria:

* Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol
* Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777
* Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study

Exclusion Criteria:

* Participants who have developed an AE while participating in the Parent Study. which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
* Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
* Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study
* Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Up to 3 years
Secondary outcomes:
measure: Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline
timeFrame: Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline.
timeFrame: Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline
timeFrame: Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants who use Rescue Therapy
timeFrame: Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants Who Continue to Exhibit EASI 75
timeFrame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants Who Continue to Exhibit vIGA-AD Response
timeFrame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
measure: Percentage of Participants Who Continue to Exhibit I-NRS Response
timeFrame: From Week 52 up to Through Extended Treatment Period, an average of 2 years
measure: Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs
timeFrame: Up to 3 years
measure: Serum Concentrations of APG777 Over Time
timeFrame: Up to 3 years
measure: Predose Serum Concentrations of APG777
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Investigational Site #25
state: California
city: Coral Gables
country: United States
facility: Investigational Site #1
state: Florida
city: Margate
country: United States
facility: Investigational Site #22
state: Florida
city: Detroit
country: United States
facility: Investigational Site #28
state: Michigan
city: Troy
country: United States
facility: Investigational Site #4
state: Michigan
city: Wilmington
country: United States
facility: Investigational Site #29
state: North Carolina
city: Boardman
country: United States
facility: Investigational Site #32
state: Ohio
city: Mason
country: United States
facility: Investigational Site #27
state: Ohio
city: Portland
country: United States
facility: Investigational Site #31
state: Oregon
city: Nashville
country: United States
facility: Investigational Site #23
state: Tennessee
city: Frisco
country: United States
facility: Investigational Site #30
state: Texas
city: San Antonio
country: United States
facility: Investigational Site #26
state: Texas
city: Calgary
country: Canada
facility: Investigational Site #6
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site #10
state: Alberta
city: Fredericton
country: Canada
facility: Investigational Site #7
state: Brunswick
city: Markham
country: Canada
facility: Investigational Site #3
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site #5
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site #24
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site #11
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site #12
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site #9
state: Ontario
city: Montréal
country: Canada
facility: Investigational Site #2
state: Quebec
city: Quebec City
country: Canada
facility: Investigational Site #8
state: Quebec
city: Wrocław
country: Poland
facility: Investigational Site #14
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Investigational Site #19
state: Dolnośląskie
city: Lublin
country: Poland
facility: Investigational Site #15
state: Lubelskie
city: Warszawa
country: Poland
facility: Investigational Site #18
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Investigational Site #17
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site #13
state: Silesia
city: Sosnowiec
country: Poland
facility: Investigational Site #16
state: Silesia
city: Kraków
country: Poland
facility: Investigational Site #20
state: Woj. Małopolskie
city: Łódź
country: Poland
facility: Investigational Site #21
Study officials:
References: