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

Recruiting · NCT07003425 · Interventional (participants receive a specific treatment) · Lead sponsor: Apogee Therapeutics, Inc.

View the official record on ClinicalTrials.gov →

Eczema

Interventions studied

APG777

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 16 US states.

Investigational Site - Fountain Valley, California, United States
Investigational Site - Los Angeles, California, United States
Investigational Site - Coral Gables, Florida, United States
Investigational Site - Jacksonville, Florida, United States
Investigational Site - Margate, Florida, United States
Investigational Site - Douglasville, Georgia, United States
Investigational Site - Skokie, Illinois, United States
Investigational Site - Bowling Green, Kentucky, United States
Investigational Site - Rockville, Maryland, United States
Investigational Site - Detroit, Michigan, United States
Investigational Site - Troy, Michigan, United States
Investigational Site - New York, New York, United States
Investigational Site - Wilmington, North Carolina, United States
Investigational Site - Boardman, Ohio, United States
Investigational Site - Mason, Ohio, United States
Investigational Site - Portland, Oregon, United States
Investigational Site - Pittsburgh, Pennsylvania, United States
Investigational Site - Charleston, South Carolina, United States
Investigational Site - Nashville, Tennessee, United States
Investigational Site - Dallas, Texas, United States
Investigational Site - Frisco, Texas, United States
Investigational Site - San Antonio, Texas, United States
Investigational Site - Mill Creek, Washington, United States
Investigational Site - Berlin, Germany
Investigational Site - Hamburg, Germany
Investigational Site - Lodz, Poland
Investigational Site - Madrid, Spain
Investigational Site - Prague, Czechia
Investigational Site - Prague, Czechia
Investigational Site - Santiago de Compostela, A Coruña, Spain
Investigational Site - Calgary, Alberta, Canada
Investigational Site - Calgary, Alberta, Canada
Investigational Site - Edmonton, Alberta, Canada
Investigational Site - Heidelberg, Baden-Wurttemberg, Germany
Investigational Site - Tübingen, Baden-Wurttemberg, Germany
Investigational Site - Augsburg, Bavaria, Germany
Investigational Site - München, Bavaria, Germany
Investigational Site - Blankenfelde-Mahlow, Brandenburg, Germany
Investigational Site - Vancouver, British Columbia, Canada
Investigational Site - Fredericton, Brunswick, Canada
Investigational Site - Las Palmas de Gran Canaria, Canary Islands, Spain
Investigational Site - Salford, Greater Manchester, United Kingdom
Investigational Site - Debrecen, Hajdú-Bihar, Hungary
Investigational Site - Darmstadt, Hesse, Germany
Investigational Site - Bad Bentheim, Lower Saxony, Germany
Investigational Site - Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site - Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site - Lublin, Lublin Voivodeship, Poland
Investigational Site - Warsaw, Masovian Voivodeship, Poland
Investigational Site - Warsaw, Masovian Voivodeship, Poland
Investigational Site - Münster, North Rhine Westfalia, Germany
Investigational Site - Ajax, Ontario, Canada
Investigational Site - Markham, Ontario, Canada
Investigational Site - Mississauga, Ontario, Canada
Investigational Site - Ottawa, Ontario, Canada
Investigational Site - Peterborough, Ontario, Canada
Investigational Site - Toronto, Ontario, Canada
Investigational Site - Toronto, Ontario, Canada
Investigational Site - Toronto, Ontario, Canada
Investigational Site - Gdansk, Pomeranian Voivodeship, Poland

Showing 60 of 71 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →