ACTIVE_NOT_RECRUITING

A Study Evaluating APG777 in Atopic Dermatitis

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Atopic DermatitisAPG777SafetyEfficacy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-29
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06395948

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of AD that has been present for \>=1 year prior to the Screening visit
  2. * Moderate-to-severe AD at Screening and Baseline visits
  3. * History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
  4. * 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.
  5. * Have completed itch questionnaires in the electronic diary for \>=4 of 7 days prior to Baseline visit
  1. * Participation in a prior study with APG777.
  2. * Prior treatment with protocol-specified monoclonal antibodies (mAbs)
  3. * Has used any AD-related topical medications within 7 days prior to Baseline visit.
  4. * 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

Contacts and Locations

Study Locations (Sites)

Investigational Site
Fountain Valley, California, 92708
United States
Investigational Site
Los Angeles, California, 90024
United States
Investigational Site
San Diego, California, 92123
United States
Investigational Site
New Haven, Connecticut, 06519
United States
Investigational Site
Coral Gables, Florida, 33134
United States
Investigational Site
Jacksonville, Florida, 32256
United States
Investigational Site
Margate, Florida, 33063
United States
Investigational Site
Douglasville, Georgia, 30135
United States
Investigational Site
Chicago, Illinois, 60657
United States
Investigational Site
Skokie, Illinois, 60077
United States
Investigational Site
West Lafayette, Indiana, 47906
United States
Investigational Site
Bowling Green, Kentucky, 42104
United States
Investigational Site
Rockville, Maryland, 20850
United States
Investigational Site
Detroit, Michigan, 48202
United States
Investigational Site
Troy, Michigan, 48084
United States
Investigational Site
Portsmouth, New Hampshire, 13801
United States
Investigational Site
New York, New York, 10023
United States
Investigational Site
Wilmington, North Carolina, 28403
United States
Investigational Site
Boardman, Ohio, 44512
United States
Investigational Site
Mason, Ohio, 45040
United States
Investigational Site
Portland, Oregon, 97201
United States
Investigational Site
Pittsburgh, Pennsylvania, 15213
United States
Investigational Site
Charleston, South Carolina, 29425
United States
Investigational Site
Nashville, Tennessee, 37215
United States
Investigational Site
Dallas, Texas, 75230
United States
Investigational Site
Dallas, Texas, 75235
United States
Investigational Site
San Antonio, Texas, 78213
United States
Investigational Site
Norfolk, Virginia, 23502
United States
Investigational Site
Mill Creek, Washington, 98012
United States

Collaborators and Investigators

Sponsor: Apogee Therapeutics, Inc.

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

Study Start Date2024-04-29
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Atopic Dermatitis
  • APG777
  • Safety
  • Efficacy

Additional Relevant MeSH Terms

  • Atopic Dermatitis