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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (10)

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

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 22 centers

• 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
• … and 14 more centers

Canada · 15 centers

• Investigational Site — Calgary
• Investigational Site — Calgary
• Investigational Site — Edmonton
• Investigational Site — Vancouver
• Investigational Site — Fredericton
• Investigational Site — Ajax
• Investigational Site — Markham
• Investigational Site — Mississauga
• … and 7 more centers

Poland · 11 centers

• Investigational Site — Wroclaw
• Investigational Site — Wroclaw
• Investigational Site — Lublin
• Investigational Site — Warsaw
• Investigational Site — Warsaw
• Investigational Site — Gdansk
• Investigational Site — Katowice
• Investigational Site — Sosnowiec
• … and 3 more centers

Germany · 10 centers

• 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
• … and 2 more centers

Czechia · 5 centers

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

Spain · 3 centers

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

Hungary · 1 center

• Investigational Site — Debrecen

Identifiers

NCT: NCT07003425 · APG777-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗