Clinical trial NCT07027527: An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
Official title: A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Moderate-to-Severe AD
APG777
Dupilumab
APG990
Lead sponsor: Apogee Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Have a diagnosis of AD that has been present for ≥ 1 year prior to the Screening visit and as determined by the Investigator through participant interview and/or review of the medical history.
* Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of ≥ 16, b) vIGA-AD score of ≥ 3, and c) AD affecting ≥10% of body surface area (BSA).
* History of inadequate response to treatment with topical medications
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit.

Exclusion Criteria

* Participation in a prior study with APG777 or APG990.
* Prior treatment with protocol-specified monoclonal antibodies (mAbs).
* Has used any AD-related topical medications within 7 days prior to Baseline visit.
* Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit
* History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab.
* Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria apply

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Predose Serum Concentrations (Ctrough) of APG777
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
measure: Predose Serum Concentrations (Ctrough) of APG990
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
measure: Maximum Serum Concentrations (Cmax) of APG777
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
measure: Maximum Serum Concentrations (Cmax) of APG990
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
measure: Time to Reach Cmax (tmax) of APG777
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
measure: Time to Reach Cmax (tmax) of APG990
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
Study officials:
References: