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

Last updated: June 25, 2025
Sponsor: Apogee Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Skin Infections/disorders

Allergy

Allergies & Asthma

Treatment

APG777

Clinical Study ID

NCT07003425
APG777-202
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participants who have completed the Treatment Period in a prior APG777 study andwere, in the Investigator's opinion, compliant with the study protocol

  • Participants who, in the Investigator's opinion, would benefit from long-termtreatment with APG777

  • Use the same non-prescription non-medicated emollient/moisturizer of their choicefrom the last day of the Parent Study and throughout the LTE study

Exclusion

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 indicatethat continued treatment with APG777 may present an unreasonable risk for thepatient

  • Participants who terminated early from the Parent Study or permanently discontinuedthe 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 thediagnosis of AD and/or interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: APG777
Phase: 2
Study Start date:
May 14, 2025
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Investigational Site #6

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Investigational Site #10

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Investigational Site #7

    Fredericton, Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigational Site #3

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Investigational Site #5

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Investigational Site #24

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Investigational Site #11

    Toronto, Ontario M3B 0A7
    Canada

    Site Not Available

  • Investigational Site #12

    Toronto, Ontario M4E 2Y9
    Canada

    Site Not Available

  • Investigational Site #9

    Toronto, Ontario M4W 2N4
    Canada

    Active - Recruiting

  • Investigational Site #2

    Montréal, Quebec H2X 2V1
    Canada

    Active - Recruiting

  • Investigational Site #8

    Quebec City, Quebec G1V 4X7
    Canada

    Active - Recruiting

  • Investigational Site #14

    Wrocław, Dolnoslaskie 50-450
    Poland

    Site Not Available

  • Investigational Site #19

    Wrocław, Dolnośląskie 51-503
    Poland

    Site Not Available

  • Investigational Site #15

    Lublin, Lubelskie 20-573
    Poland

    Site Not Available

  • Investigational Site #18

    Warszawa, Mazowieckie 02-482
    Poland

    Site Not Available

  • Investigational Site #17

    Gdańsk, Pomorskie 80-546
    Poland

    Site Not Available

  • Investigational Site #13

    Katowice, Silesia 40-600
    Poland

    Site Not Available

  • Investigational Site #16

    Sosnowiec, Silesia 41-218
    Poland

    Site Not Available

  • Investigational Site #20

    Kraków, Woj. Małopolskie 30-727
    Poland

    Site Not Available

  • Investigational Site #21

    Łódź, 90-237
    Poland

    Site Not Available

  • Investigational Site #25

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Investigational Site #1

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site #22

    Margate, Florida 33063
    United States

    Site Not Available

  • Investigational Site #28

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Investigational Site #4

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Investigational Site #29

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Investigational Site #32

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Investigational Site #27

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Investigational Site #31

    Portland, Oregon 97223
    United States

    Site Not Available

  • Investigational Site #23

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Investigational Site #30

    Frisco, Texas 75235
    United States

    Site Not Available

  • Investigational Site #26

    San Antonio, Texas 78213
    United States

    Site Not Available

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