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A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients with Moderate-to-severe Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511260-84-00
Acronym
APG777-201
Enrollment
163
Registered
2024-08-12
Start date
2024-09-03
Completion date
Unknown
Last updated
2025-12-18

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

Conditions

Atopic Dermatitis

Brief summary

Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16

Detailed description

Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks], Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52], Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52], Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52], Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through Week 16 and at Week 52], Serum Concentrations of APG777 Over Time [Time Frame: Up to 106 Weeks], Predose Serum Concentrations of APG777 (Ctrough) [Time Frame: Up to 106 Weeks], Maximum concentration (Cmax) of APG777 [Time Frame: Up to 106 Weeks], Time to reach Cmax (tmax) [Time Frame: Up to 106 Weeks], Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period [Time Frame: Baseline to 16 Weeks], AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period [Time Frame: 16 Weeks to 52 Weeks]

Interventions

DRUGPlacebo
DRUGAPG777

Sponsors

Apogee Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16

Secondary

MeasureTime frame
Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks], Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52], Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52], Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52], Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52], Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through W

Countries

Czechia, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

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