Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, APG777, Safety, Efficacy
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.
Interventions
DRUGAPG777
APG777 subcutaneous injection
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 use Rescue Therapy | 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 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 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 | — |
| 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 |
| Predose Serum Concentrations of APG777 | Up to 3 years | — |
Countries
Canada, Czechia, Germany, Hungary, Poland, Spain, United Kingdom, United States
Contacts
CONTACTStudy Director
Outcome results
None listed