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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion 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

Exclusion Criteria:

* 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 from 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

Note: Additional protocol defined Inclusion/Exclusion criteria may apply

About the study

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.

What is being tested

Sponsor: Apogee Therapeutics, Inc. · Participants: 350 · Started: May 14, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07003425

Locations in the U.S.

CaliforniaInvestigational Site, Fountain Valley
Investigational Site, Los Angeles
FloridaInvestigational Site, Coral Gables
Investigational Site, Jacksonville
Investigational Site, Margate
GeorgiaInvestigational Site, Douglasville
IllinoisInvestigational Site, Skokie
KentuckyInvestigational Site, Bowling Green
MarylandInvestigational Site, Rockville
MichiganInvestigational Site, Detroit
Investigational Site, Troy
New YorkInvestigational Site, New York
North CarolinaInvestigational Site, Wilmington
OhioInvestigational Site, Boardman
Investigational Site, Mason
OregonInvestigational Site, Portland
PennsylvaniaInvestigational Site, Pittsburgh
South CarolinaInvestigational Site, Charleston
TennesseeInvestigational Site, Nashville
TexasInvestigational Site, Dallas
Investigational Site, Frisco
Investigational Site, San Antonio
WashingtonInvestigational Site, Mill Creek

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.