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

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.

Conditions

Atopic Dermatitis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Investigational Site #25, Fountain Valley, California, United States, 92708

Coral Gables

Investigational Site #1, Coral Gables, Florida, United States, 33134

Margate

Investigational Site #22, Margate, Florida, United States, 33063

Detroit

Investigational Site #28, Detroit, Michigan, United States, 48202

Troy

Investigational Site #4, Troy, Michigan, United States, 48084

Wilmington

Investigational Site #29, Wilmington, North Carolina, United States, 28403

Boardman

Investigational Site #32, Boardman, Ohio, United States, 44512

Mason

Investigational Site #27, Mason, Ohio, United States, 45040

Portland

Investigational Site #31, Portland, Oregon, United States, 97223

Nashville

Investigational Site #23, Nashville, Tennessee, United States, 37215

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol
  • * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777
  • * 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
  • * 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
  • * Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
  • * Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study
  • * Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Apogee Therapeutics, Inc.,

Study Record Dates

2029-12