A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

Официальное название

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

Обзор

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.

Вмешательства

• Препарат APG777
  APG777 subcutaneous injection
• Препарат APG777
  APG777 subcutaneous injection every 12 weeks
• Препарат APG777
  APG777 subcutaneous injection every 24 weeks

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events [Срок оценки: Up to 3 years]

Вторичные конечные точки (10)

• Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Through Extended Treatment Period, an average of 2 years]
• Percentage of Participants who use Rescue Therapy [Срок оценки: Through Extended Treatment Period, an average of 2 years]
• Percentage of Participants Who Continue to Exhibit EASI 75 [Срок оценки: From Week 52 up to Through Extended Treatment Period, an average of 2 years]
• Percentage of Participants Who Continue to Exhibit vIGA-AD Response [Срок оценки: From Week 52 up to Through Extended Treatment Period, an average of 2 years]
• Percentage of Participants Who Continue to Exhibit I-NRS Response [Срок оценки: From Week 52 up to Through Extended Treatment Period, an average of 2 years]
• Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs [Срок оценки: Up to 3 years]
• Serum Concentrations of APG777 Over Time [Срок оценки: Up to 3 years]
• Predose Serum Concentrations of APG777 [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 from 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 22 центра

• Investigational Site — Fountain Valley
• Investigational Site — Los Angeles
• Investigational Site — Coral Gables
• Investigational Site — Jacksonville
• Investigational Site — Margate
• Investigational Site — Douglasville
• Investigational Site — Skokie
• Investigational Site — Bowling Green
• … и ещё 14 центров

Канада · 15 центров

• Investigational Site — Calgary
• Investigational Site — Calgary
• Investigational Site — Edmonton
• Investigational Site — Vancouver
• Investigational Site — Fredericton
• Investigational Site — Ajax
• Investigational Site — Markham
• Investigational Site — Mississauga
• … и ещё 7 центров

Польша · 11 центров

• Investigational Site — Wroclaw
• Investigational Site — Wroclaw
• Investigational Site — Lublin
• Investigational Site — Warsaw
• Investigational Site — Warsaw
• Investigational Site — Gdansk
• Investigational Site — Katowice
• Investigational Site — Sosnowiec
• … и ещё 3 центра

Германия · 10 центров

• Investigational Site — Heidelberg
• Investigational Site — Tübingen
• Investigational Site — Augsburg
• Investigational Site — München
• Investigational Site — Blankenfelde-Mahlow
• Investigational Site — Bad Bentheim
• Investigational Site — Münster
• Investigational Site — Dresden
• … и ещё 2 центра

Чехия · 5 центров

• Investigational Site — Prague
• Investigational Site — Prague
• Investigational Site — Prague
• Investigational Site — Prague
• Investigational Site — Prague

Испания · 3 центра

• Investigational Site — Santiago de Compostela
• Investigational Site — Las Palmas de Gran Canaria
• Investigational Site — Madrid

Венгрия · 1 центр

• Investigational Site — Debrecen

Идентификаторы

NCT: NCT07003425 · APG777-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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