An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis

Phase 1

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: APG777; Drug: Dupilumab; Drug: APG990

• Registration Number: NCT07027527
• Lead Sponsor: Apogee Therapeutics, Inc.

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).

Detailed Description

Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-04
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APG777 + APG990	APG777	Participants will receive protocol specified combination dose of APG777 + APG990
APG777 + APG990	APG990	Participants will receive protocol specified combination dose of APG777 + APG990
Dupilumab	Dupilumab	Participants will receive protocol specified dose of Dupilumab

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Predose Serum Concentrations (Ctrough) of APG777	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software.
Predose Serum Concentrations (Ctrough) of APG990	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software.
Maximum Serum Concentrations (Cmax) of APG777	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software
Maximum Serum Concentrations (Cmax) of APG990	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software.
Time to Reach Cmax (tmax) of APG777	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Time to Reach Cmax (tmax) of APG990	Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24	PK parameters will be performed using a non-compartmental approach with a validated PK software. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

Trial Locations

Locations (1)

Skin Health Institute; 🇦🇺 Carlton, Victoria, Australia