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A Study Evaluating APG777 in Atopic Dermatitis

Purpose

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

Condition

Atopic Dermatitis

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Note: Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The Sponsor's study staff will also be blinded in the study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Induction Period: APG777	Participants will receive APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Placebo Comparator Part A: Induction Period: Placebo	Participants will receive matching Placebo injections per protocol defined dosing regimen	Drug: Placebo Matching placebo subcutaneous injection
Experimental Part A: Maintenance Period: APG777	Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Experimental Part B: Induction Period: APG777	Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection
Placebo Comparator Part B: Induction Period: Placebo	Participants will receive matching placebo injections per protocol defined dosing regimen	Drug: Placebo Matching placebo subcutaneous injection
Experimental Part B: Maintenance Period: APG777	Participants will receive APG777 per protocol defined dosing regimen	Drug: APG777 APG777 subcutaneous injection

Recruiting Locations

More Details

NCT ID: NCT06395948
Status: Active, not recruiting
Sponsor: Apogee Therapeutics, Inc.