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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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 Note: Additional protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
APG777 - Long Term Extension Treatment - 12 Weeks 		Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
  • Drug: APG777
    APG777 subcutaneous injection every 12 weeks
Experimental
APG777 - Long Term Extension Treatment - 24 Weeks 		Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
  • Drug: APG777
    APG777 subcutaneous injection every 24 weeks
Experimental
APG777 - Open Label Escape Arm 		Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.
  • Drug: APG777
    APG777 subcutaneous injection

Recruiting Locations

Investigational Site
Fountain Valley 5350207, California 5332921 92708

Investigational Site
Coral Gables 4151871, Florida 4155751 33134

Investigational Site
Margate 4163407, Florida 4155751 33063

Investigational Site
Detroit 4990729, Michigan 5001836 48202

Investigational Site
Troy 5012639, Michigan 5001836 48084

Investigational Site
Mason 4517698, Ohio 5165418 45040

Investigational Site
Portland 5746545, Oregon 5744337 97223

Investigational Site
Nashville 4644585, Tennessee 4662168 37215

Investigational Site
Frisco 4692559, Texas 4736286 75235

Investigational Site
San Antonio 4726206, Texas 4736286 78213

More Details

Status
Recruiting
Sponsor
Apogee Therapeutics, Inc.

Study Contact

Study Director
7812082408
ClinicalTrials@apogeetherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.