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

A

Apogee Therapeutics, Inc.

Status and phase

Enrolling
Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: Dupilumab
Drug: APG777
Drug: APG990

Study type

Interventional

Funder types

Industry

Identifiers

NCT07027527
APG279-101

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

APG777 + APG990
Experimental group
Description:
Participants will receive protocol specified combination dose of APG777 + APG990
Treatment:
Drug: APG990
Drug: APG777
Dupilumab
Active Comparator group
Description:
Participants will receive protocol specified dose of Dupilumab
Treatment:
Drug: Dupilumab

Trial contacts and locations

13

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Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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