NCT07003425 · Apogee Therapeutics, Inc.
A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
What this study is about
This is a conducted at multiple hospitals, where neither patients nor doctors know which treatment is given, Long-Term Extension (LTE) study to evaluate the long-term safety and effectiveness of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
View original scientific 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.
Interventions
DRUG
APG777
APG777 subcutaneous injection
DRUG
APG777
APG777 subcutaneous injection every 12 weeks
DRUG
APG777
APG777 subcutaneous injection every 24 weeks
Primary outcome measures
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 3 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 t
Where
- Fountain Valley, California
- Los Angeles, California
- Coral Gables, Florida
- Jacksonville, Florida
- Margate, Florida
- Douglasville, Georgia
- Skokie, Illinois
- Bowling Green, Kentucky
- Detroit, Michigan
- Troy, Michigan
- New York, New York
- Wilmington, North Carolina
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations