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APG777-202 - A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519795-11-00
Acronym
APG777-202
Enrollment
91
Registered
2025-08-11
Start date
2025-10-06
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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

Detailed description

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 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 [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years], Percentage of Participants Who Continue to Exhibit vIGA-AD Response 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. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years], Percentage of Participants Who Continue to Exhibit I-NRS Response 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. [Time Frame: From Week 52 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]

Interventions

DRUGAPG777
DRUGPlacebo

Sponsors

Apogee Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 Of the participants who achieve EASI 75 at Week 52 of the Parent Study,

Countries

France, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026