A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Launched by APOGEE THERAPEUTICS, INC. · May 26, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called APG777 to see how safe and effective it is for people with moderate-to-severe atopic dermatitis (AD), a condition that causes itchy and inflamed skin. The trial is a follow-up for individuals who have completed an earlier study of APG777. It will take place in three parts: a screening visit, an extended treatment period, and a follow-up period after treatment ends. The goal is to understand how the medication works over a longer time and to ensure it remains safe for participants.
To be eligible for this trial, participants must have successfully finished the previous APG777 study and be considered by their doctor to potentially benefit from ongoing treatment. They should also continue using the same moisturizer they used during the earlier study. However, individuals who had side effects during the previous study, left the study early, or have other skin conditions that could complicate the results won't be able to participate. If you or a family member are interested, this is a chance to help researchers learn more about managing atopic dermatitis with APG777.
Gender
ALL
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 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
About Apogee Therapeutics, Inc.
Apogee Therapeutics, Inc. is an innovative biopharmaceutical company dedicated to advancing the development of targeted therapies for patients with serious and underserved medical conditions. With a focus on harnessing cutting-edge scientific research and technology, Apogee Therapeutics aims to create novel treatments that improve patient outcomes and enhance quality of life. The company's commitment to rigorous clinical trials and collaboration with healthcare professionals underscores its mission to deliver safe, effective, and transformative solutions in the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Coral Gables, Florida, United States
Fountain Valley, California, United States
Margate, Florida, United States
Detroit, Michigan, United States
Troy, Michigan, United States
Wilmington, North Carolina, United States
Boardman, Ohio, United States
Mason, Ohio, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Frisco, Texas, United States
San Antonio, Texas, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Fredericton, Brunswick, Canada
Markham, Ontario, Canada
Mississauga, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montréal, Quebec, Canada
Quebec City, Quebec, Canada
Wrocław, Dolnoslaskie, Poland
Wrocław, Dolnośląskie, Poland
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Gdańsk, Pomorskie, Poland
Katowice, Silesia, Poland
Sosnowiec, Silesia, Poland
Kraków, Woj. Małopolskie, Poland
łódź, , Poland
Wrocław, , Poland
Kraków, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported