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A Study Evaluating APG777 in Atopic Dermatitis
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.
Conditions:
🦠 Atopic Dermatitis
🗓️ Study Start (Actual) 29 April 2024
🗓️ Primary Completion (Estimated) November 2026
✅ Study Completion (Estimated) June 2028
👥 Enrollment (Estimated) 471
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Fountain Valley, California, United States
📍 San Diego, California, United States
📍 Coral Gables, Florida, United States
📍 Margate, Florida, United States
📍 Rockville, Maryland, United States
📍 Troy, Michigan, United States
📍 Portsmouth, New Hampshire, United States
📍 Wilmington, North Carolina, United States
📍 Mason, Ohio, United States
📍 Portland, Oregon, United States
📍 Nashville, Tennessee, United States
📍 San Antonio, Texas, United States
📍 Norfolk, Virginia, United States
📍 Mill Creek, Washington, United States
📍 Winnipeg, Manitoba, Canada
📍 Fredericton, New Brunswick, Canada
📍 Markham, Ontario, Canada
📍 Peterborough, Ontario, Canada
📍 Toronto, Ontario, Canada
📍 Toronto, Ontario, Canada
📍 Montreal, Quebec, Canada
📍 Québec, Quebec, Canada
More locations available...

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 April 2024
  • First Submitted that Met QC Criteria 29 April 2024
  • First Posted 2 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024
I'm interested ...!!