A Study to Evaluate the Safety and Effectiveness of APG777 in Subjects with Atopic Dermatitis

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2024-511260-84-00
• Lead Sponsor: Apogee Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

• Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit, • Moderate-to-severe AD at Screening and Baseline visits, • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable, • Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits, • Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit

Exclusion Criteria

• Participation in a prior study with APG777, • 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified