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NCT07003425PHASE2Recruiting

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

Apogee Therapeutics, Inc.

Start Date

5/14/2025

Completion Date

12/1/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

APG777

DRUG

APG777

DRUG

APG777

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Conditions

Atopic Dermatitis

Locations

Investigational Site

Fountain Valley, California 92708

United States

Investigational Site

Los Angeles, California 90024

United States

Investigational Site

Coral Gables, Florida 33134

United States

Investigational Site

Jacksonville, Florida 32256

United States

Investigational Site

Margate, Florida 33063

United States

Investigational Site

Douglasville, Georgia 30135

United States

Investigational Site

Skokie, Illinois 60077

United States

Investigational Site

Bowling Green, Kentucky 42101

United States

Investigational Site

Detroit, Michigan 48202

United States

Investigational Site

Troy, Michigan 48084

United States

Investigational Site

New York, New York 10023

United States

Investigational Site

Wilmington, North Carolina 28403

United States

Investigational Site

Boardman, Ohio 44512

United States

Investigational Site

Mason, Ohio 45040

United States

Investigational Site

Portland, Oregon 97223

United States

Investigational Site

Pittsburgh, Pennsylvania 15213

United States

Investigational Site

Charleston, South Carolina 29425

United States

Investigational Site

Nashville, Tennessee 37215

United States

Investigational Site

Dallas, Texas 75230

United States

Investigational Site

Frisco, Texas 75235

United States

Investigational Site

San Antonio, Texas 78213

United States

Investigational Site

Mill Creek, Washington 98012

United States

Investigational Site

Calgary, Alberta T2J 7E1

Canada

Investigational Site

Calgary, Alberta T3E 0B2

Canada

Investigational Site

Edmonton, Alberta T5J 3S9

Canada

Investigational Site

Vancouver, British Columbia V5Z 4E8

Canada

Investigational Site

Fredericton, Brunswick E3B 1G9

Canada

Investigational Site

Ajax, Ontario L1S 7K8

Canada

Investigational Site

Markham, Ontario L3P 1X3

Canada

Investigational Site

Mississauga, Ontario L4Y 4C5

Canada

Investigational Site

Ottawa, Ontario K1K 4L2

Canada

Investigational Site

Peterborough, Ontario K9J 5K2

Canada

Investigational Site

Toronto, Ontario M3B 0A7

Canada

Investigational Site

Toronto, Ontario M4E 2Y9

Canada

Investigational Site

Toronto, Ontario M4W 2N4

Canada

Investigational Site

Montreal, Quebec H2X 2V1

Canada

Investigational Site

Québec, Quebec G1V 4X7

Canada

Investigational Site

Prague, Prague 128 00

Czechia

Investigational Site

Prague, Prague Motol 150 06

Czechia

Investigational Site

Prague, Vinohrady 100 34

Czechia

Investigational Site

Prague, 100 00

Czechia

Investigational Site

Prague, 16000

Czechia

Investigational Site

Heidelberg, Baden-Wurttemberg 69120

Germany

Investigational Site

Tübingen, Baden-Wurttemberg 72076

Germany

Investigational Site

Augsburg, Bavaria 86179

Germany

Investigational Site

München, Bavaria 80337

Germany

Investigational Site

Blankenfelde-Mahlow, Brandenburg 15831

Germany

Investigational Site

Bad Bentheim, Lower Saxony 48455

Germany

Investigational Site

Münster, North Rhine Westfalia 48149

Germany

Investigational Site

Dresden, Saxony 1307

Germany

Investigational Site

Kiel, Schleswig-Holstein 24105

Germany

Investigational Site

Hamburg, 20354

Germany

Investigational Site

Debrecen, Hajdú-Bihar 4032

Hungary

Investigational Site

Wroclaw, Lower Silesian Voivodeship 50-450

Poland

Investigational Site

Wroclaw, Lower Silesian Voivodeship 51-503

Poland

Investigational Site

Lublin, Lublin Voivodeship 20-573

Poland

Investigational Site

Warsaw, Masovian Voivodeship 01-595

Poland

Investigational Site

Warsaw, Masovian Voivodeship 02-482

Poland

Investigational Site

Gdansk, Pomeranian Voivodeship 80-546

Poland

Investigational Site

Katowice, Silesian Voivodeship 40-600

Poland

Investigational Site

Sosnowiec, Silesian Voivodeship 41-218

Poland

Investigational Site

Szczecin, West Pomeranian Voivodeship 71-500

Poland

Investigational Site

Krakow, Woj. Małopolskie 30-727

Poland

Investigational Site

Lodz, 90-237

Poland

Investigational Site

Santiago de Compostela, A Coruña 15706

Spain

Investigational Site

Las Palmas de Gran Canaria, Canary Islands 35010

Spain

Investigational Site

Madrid, 28006

Spain