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Search / Trial NCT07003425

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

Atopic Dermatitis Apg777 Safety Efficacy

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported