A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
- Registration Number
- NCT07003425
- Lead Sponsor
- Apogee Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description APG777 - Long Term Extension Treatment - 12 Weeks APG777 Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). APG777 - Long Term Extension Treatment - 24 Weeks APG777 Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). APG777 - Open Label Escape Arm APG777 Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events Up to 3 years
- Secondary Outcome Measures
Name Time Method Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline Through Extended Treatment Period, an average of 2 years 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. Through Extended Treatment Period, an average of 2 years 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 Through Extended Treatment Period, an average of 2 years Percentage of Participants who use Rescue Therapy Through Extended Treatment Period, an average of 2 years Percentage of Participants Who Continue to Exhibit EASI 75 From Week 52 up to Through Extended Treatment Period, an average of 2 years Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined
Percentage of Participants Who Continue to Exhibit vIGA-AD Response From Week 52 up to Through Extended Treatment Period, an average of 2 years Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.
Percentage of Participants Who Continue to Exhibit I-NRS Response From Week 52 up to Through Extended Treatment Period, an average of 2 years Of the participants who achieve a ≥ 4 point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.
Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs Up to 3 years Serum Concentrations of APG777 Over Time Up to 3 years Predose Serum Concentrations of APG777 Up to 3 years
Trial Locations
- Locations (32)
Investigational Site #25
🇺🇸Fountain Valley, California, United States
Investigational Site #1
🇺🇸Coral Gables, Florida, United States
Investigational Site #22
🇺🇸Margate, Florida, United States
Investigational Site #28
🇺🇸Detroit, Michigan, United States
Investigational Site #4
🇺🇸Troy, Michigan, United States
Investigational Site #29
🇺🇸Wilmington, North Carolina, United States
Investigational Site #32
🇺🇸Boardman, Ohio, United States
Investigational Site #27
🇺🇸Mason, Ohio, United States
Investigational Site #31
🇺🇸Portland, Oregon, United States
Investigational Site #23
🇺🇸Nashville, Tennessee, United States
Investigational Site #30
🇺🇸Frisco, Texas, United States
Investigational Site #26
🇺🇸San Antonio, Texas, United States
Investigational Site #6
🇨🇦Calgary, Alberta, Canada
Investigational Site #10
🇨🇦Edmonton, Alberta, Canada
Investigational Site #7
🇨🇦Fredericton, Brunswick, Canada
Investigational Site #3
🇨🇦Markham, Ontario, Canada
Investigational Site #5
🇨🇦Mississauga, Ontario, Canada
Investigational Site #24
🇨🇦Peterborough, Ontario, Canada
Investigational Site #11
🇨🇦Toronto, Ontario, Canada
Investigational Site #12
🇨🇦Toronto, Ontario, Canada
Investigational Site #9
🇨🇦Toronto, Ontario, Canada
Investigational Site #2
🇨🇦Montréal, Quebec, Canada
Investigational Site #8
🇨🇦Quebec City, Quebec, Canada
Investigational Site #14
🇵🇱Wrocław, Dolnoslaskie, Poland
Investigational Site #19
🇵🇱Wrocław, Dolnośląskie, Poland
Investigational Site #15
🇵🇱Lublin, Lubelskie, Poland
Investigational Site #18
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site #17
🇵🇱Gdańsk, Pomorskie, Poland
Investigational Site #13
🇵🇱Katowice, Silesia, Poland
Investigational Site #16
🇵🇱Sosnowiec, Silesia, Poland
Investigational Site #20
🇵🇱Kraków, Woj. Małopolskie, Poland
Investigational Site #21
🇵🇱Łódź, Poland