Explore the Potential of APG777 for Treating Atopic Dermatitis

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.

New York location for dermatology study by Equity Medical
Study Location
New York
Office Address

200 Amsterdam Ave. New York, NY 10023

Office Phone
646-413-6020

Overview

Recruiting start date
  • January 15, 2025
Duration
  • 106 weeks
Population

18 Years and older (Adult, Older Adult ) With Atopic Dermatitis

Study Drug

APG777

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
What You Can Expect

The study will include visits to our study center where the patient will initially receive a thorough physical examination, including an EKG and blood work at no cost to the patient to assess the participants baseline health. Moreover, the patient will receive a screening examination from a dermatology specialist to confirm the diagnosis of the study disease. After informed consent and if the participants elects to continue in the study, the patient will either be given the active medication (i.e. APG777) or a placebo. There will be regular follow up visits to assess the effectiveness and safety of the therapies.

Studies
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