A Study Evaluating APG777 in Atopic Dermatitis

Apogee Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: APG777

Study type: Interventional

Funder types: Industry

Identifiers

NCT06395948

APG777-201

Details and patient eligibility

About

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 will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. One maintenance regimen will be evaluated in Part B. 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.

Enrollment: 471 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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471 participants in 6 patient groups, including a placebo group

Part A: Induction Period: APG777

Experimental group

Description:

Participants will receive APG777 per protocol defined dosing regimen

Treatment:

Drug: APG777

Part A: Induction Period: Placebo

Placebo Comparator group

Description:

Participants will receive matching Placebo injections per protocol defined dosing regimen

Treatment:

Drug: Placebo

Part A: Maintenance Period: APG777

Experimental group

Description:

Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen

Treatment:

Drug: APG777

Part B: Induction Period: APG777

Experimental group

Description:

Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen

Treatment:

Drug: APG777

Part B: Induction Period: Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo injections per protocol defined dosing regimen

Treatment:

Drug: Placebo

Part B: Maintenance Period: APG777

Experimental group

Description:

Participants will receive APG777 per protocol defined dosing regimen

Treatment:

Drug: APG777