RECRUITING

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

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 multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948). The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period. This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

Official Title

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

Quick Facts

Study Start:2025-05-14
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07003425

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. * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol
  2. * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777
  3. * Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study
  1. * Participants who have developed an AE while participating in the Parent Study. which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
  2. * Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
  3. * Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study
  4. * Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Contacts and Locations

Study Contact

Study Director
CONTACT
7812082408
ClinicalTrials@apogeetherapeutics.com

Study Locations (Sites)

Investigational Site #25
Fountain Valley, California, 92708
United States
Investigational Site #1
Coral Gables, Florida, 33134
United States
Investigational Site #22
Margate, Florida, 33063
United States
Investigational Site #28
Detroit, Michigan, 48202
United States
Investigational Site #4
Troy, Michigan, 48084
United States
Investigational Site #29
Wilmington, North Carolina, 28403
United States
Investigational Site #32
Boardman, Ohio, 44512
United States
Investigational Site #27
Mason, Ohio, 45040
United States
Investigational Site #31
Portland, Oregon, 97223
United States
Investigational Site #23
Nashville, Tennessee, 37215
United States
Investigational Site #30
Frisco, Texas, 75235
United States
Investigational Site #26
San Antonio, Texas, 78213
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 Date2025-05-14
Study Completion Date2029-12

Study Record Updates

Study Start Date2025-05-14
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Atopic Dermatitis
  • APG777
  • Safety
  • Efficacy

Additional Relevant MeSH Terms

  • Atopic Dermatitis