A Study Evaluating APG777 in Atopic Dermatitis

Last updated: March 20, 2025
Sponsor: Apogee Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Skin Infections/disorders

Rosacea

Treatment

APG777

Placebo

Clinical Study ID

NCT06395948
APG777-201
  • Ages > 18
  • All Genders

Study Summary

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of AD that has been present for >=1 year prior to the Screeningvisit

  • Moderate-to-severe AD at Screening and Baseline visits

  • History of inadequate response to treatment with topical medications, or medicaldetermination that topical therapies are inadvisable

  • Applied a stable dose of non-medicated over-the-counter emollient/moisturizer oftheir choice on their skin for >=14 days prior to Baseline visit and agrees tocontinue using the same moisturizer throughout the study except the day of the studyvisits.

  • Have completed itch questionnaires in the electronic diary for >=4 of 7 days priorto Baseline visit

Exclusion

Exclusion Criteria:

  • Participation in a prior study with APG777.

  • Prior treatment with protocol-specified monoclonal antibodies (mAbs)

  • Has used any AD-related topical medications within 7 days prior to Baseline visit.

  • Has used systemic treatments (other than biologics) and/or phototherapies and/orlaser therapy that could affect AD within 4 weeks prior to Baseline visit

Note: Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 391
Treatment Group(s): 2
Primary Treatment: APG777
Phase: 2
Study Start date:
April 29, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Investigational Site # 26

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • Investigational Site #51

    Calgary, Alberta T3E 0B2
    Canada

    Active - Recruiting

  • Investigational Site # 32

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

  • Investigational Site #19

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Active - Recruiting

  • Investigational Site #15

    Fredericton, New Brunswick E3B 1G9
    Canada

    Active - Recruiting

  • Investigational Site # 9

    Markham, Ontario L3P1X3
    Canada

    Active - Recruiting

  • Investigational Site # 25

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Investigational Site #13

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Investigational Site # 20

    Toronto, Ontario M3B 0A7
    Canada

    Active - Recruiting

  • Investigational Site # 24

    Toronto, Ontario M4E 2Y9
    Canada

    Active - Recruiting

  • Investigational Site #11

    Toronto, Ontario M4W 2N4
    Canada

    Active - Recruiting

  • Investigational Site # 6

    Montreal, Quebec H2X 2V1
    Canada

    Active - Recruiting

  • Investigational Site #17

    Québec, Quebec G1V4X7
    Canada

    Active - Recruiting

  • Investigational Site # 35

    Wrocław, Dolnoslaskie 50-450
    Poland

    Active - Recruiting

  • Investigational Site # 39

    Wrocław, Dolnoslaskie 51-503
    Poland

    Active - Recruiting

  • Investigational Site # 40

    Lublin, Lubelskie 20-573
    Poland

    Active - Recruiting

  • Investigational Site # 42

    Warsaw, Mazowieckie 01-595
    Poland

    Active - Recruiting

  • Investigational Site # 27

    Warszawa, Mazowieckie 02-482
    Poland

    Active - Recruiting

  • Investigational Site # 41

    Gdańsk, Pomorskie 80-546
    Poland

    Active - Recruiting

  • Investigational Site # 28

    Katowice, Silesia 40-600
    Poland

    Active - Recruiting

  • Investigational Site # 29

    Sosnowiec, Silesia 41-218
    Poland

    Active - Recruiting

  • Investigational Site # 30

    Kraków, Woj. Małopolskie 30-727
    Poland

    Active - Recruiting

  • Investigational Site # 45

    Łódź, Łódzkie 90-237
    Poland

    Active - Recruiting

  • Investigational Site #14

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Investigational Site # 46

    Los Angeles, California 90024
    United States

    Active - Recruiting

  • Investigational Site # 8

    San Diego, California 92123
    United States

    Active - Recruiting

  • Investigational Site # 44

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Investigational Site # 1

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site #1

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Investigational site #48

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Investigational Site # 21

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Investigational site #47

    Douglasville, Georgia 30135
    United States

    Active - Recruiting

  • Investigational Site # 36

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Investigational Site # 38

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Investigational site #50

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Investigational Site # 2

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Investigational Site # 43

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Investigational Site #10

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Investigational Site #16

    Portsmouth, New Hampshire 13801
    United States

    Active - Recruiting

  • Investigational site #49

    New York, New York 10023
    United States

    Active - Recruiting

  • Investigational Site # 3

    Wilmington, North Carolina 28403
    United States

    Active - Recruiting

  • Investigational Site # 31

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Investigational Site #12

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Investigational Site #22

    Portland, Oregon 97201
    United States

    Active - Recruiting

  • Investigational Site # 34

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Investigational Site # 37

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Investigational Site # 4

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Investigational Site # 23

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Investigational Site # 33

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Investigational Site # 18

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Investigational Site # 5

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Investigational Site # 7

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

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