Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07003425

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

Conditions: Atopic Dermatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 350
Sponsor: Apogee Therapeutics, Inc.

Location: Investigational Site Fountain Valley California

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07003425). StuddyBuddy aggregates publicly available trial information.