Atopic Dermatitis
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Atopic Dermatitis
APG777-201 Enrolling

Clinical Trial for Atopic Dermatitis (Approximately 2 years)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults aged 18 and above diagnosed with atopic dermatitis (eczema) may participate.

 

Inclusion Criteria

  • Diagnosis of moderate-to-severe atopic dermatitis (AD) present for at least a year
  • AD involvement on 10% or more of your body surface area (BSA)*
  • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers).

 

What Are The Benefits?

  • No cost to participate or receive study treatment
  • Regular visits with study doctors who specialize in treating AD (22 study visits)
  • Will receive either an investigative drug or a placebo – after week 16 until week 52 all participants receive APG777

 

How long will the study last?

  • Approximately 2 years

Note: Participants must apply an over-the-counter emollient/moisturizer of their choice for the duration of the study.

 


Participating Locations

COUNTRY
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United States
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Canada

Participating Experts

Dr. Melinda Gooderham

Dermatologist

Dr. Sameh Hanna

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. G. Daniel Schachter

Dermatologist

Dr. Rocco Serrao

Dermatologist

Dr. Irina Turchin

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 09, 2024

Official Title

A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis

ClinicalTrials.gov ID

NCT06395948

Sponsor

Apogee Therapeutics, Inc.

Study Description

  • Brief Summary:

    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.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: APG777
    Drug: Placebo
    Drug: APG777
    Drug: APG777
    Drug: Placebo
    Drug: APG777
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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