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

Last updated: March 25, 2026
Sponsor: Apogee Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Atopic Dermatitis

Eczema (Atopic Dermatitis)

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

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • Investigational Site #6

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Investigational Site

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

  • Investigational Site #10

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Investigational Site

    Calgary 5913490, Alberta 5883102 T2J 7E1
    Canada

    Site Not Available

  • Investigational Site

    Edmonton 5946768, Alberta 5883102 T5J 3S9
    Canada

    Site Not Available

  • Investigational Site

    Fredericton, Brunswick E3B 1G9
    Canada

    Active - Recruiting

  • Investigational Site #7

    Fredericton, Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigational Site

    Fredericton 5957776, Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigational Site

    Ajax, Ontario L1S 7K8
    Canada

    Active - Recruiting

  • Investigational Site

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Investigational Site #3

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Investigational Site

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Investigational Site #5

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Investigational Site

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Investigational Site #24

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Investigational Site

    Toronto, Ontario M4W 2N4
    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

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Site Not Available

  • Investigational Site

    Mississauga 6075357, Ontario 6093943 L4Y 4C5
    Canada

    Site Not Available

  • Investigational Site

    Peterborough 6101645, Ontario 6093943 K9J 5K2
    Canada

    Site Not Available

  • Investigational Site

    Toronto 6167865, Ontario 6093943 M4W 2N4
    Canada

    Site Not Available

  • Investigational Site

    Montreal, Quebec H2X 2V1
    Canada

    Active - Recruiting

  • Investigational Site

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Investigational Site #2

    Montréal, Quebec H2X 2V1
    Canada

    Active - Recruiting

  • Investigational Site

    Quebec City, Quebec G1V 4X7
    Canada

    Site Not Available

  • Investigational Site #8

    Quebec City, Quebec G1V 4X7
    Canada

    Active - Recruiting

  • Investigational Site

    Québec, Quebec G1V 4X7
    Canada

    Active - Recruiting

  • Investigational Site

    Montreal 6077243, Quebec 6115047 H2X 2V1
    Canada

    Site Not Available

  • Investigational Site

    Québec 6325494, Quebec 6115047 G1V 4X7
    Canada

    Site Not Available

  • Investigational Site #14

    Wrocław, Dolnoslaskie 50-450
    Poland

    Site Not Available

  • Investigational Site

    Wrocław, Dolnośląskie 51-503
    Poland

    Site Not Available

  • Investigational Site #19

    Wrocław, Dolnośląskie 51-503
    Poland

    Site Not Available

  • Investigational Site

    Wroclaw, Lower Silesian Voivodeship 50-450
    Poland

    Active - Recruiting

  • Investigational Site

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 50-450
    Poland

    Site Not Available

  • Investigational Site #15

    Lublin, Lubelskie 20-573
    Poland

    Site Not Available

  • Investigational Site

    Lublin, Lublin Voivodeship 20-573
    Poland

    Active - Recruiting

  • Investigational Site

    Lublin 765876, Lublin Voivodeship 858785 20-573
    Poland

    Site Not Available

  • Investigational Site

    Warsaw, Masovian Voivodeship 02-482
    Poland

    Active - Recruiting

  • Investigational Site

    Warsaw 756135, Masovian Voivodeship 858787 01-595
    Poland

    Site Not Available

  • Investigational Site

    Warszawa, Mazowieckie 02-482
    Poland

    Site Not Available

  • Investigational Site #18

    Warszawa, Mazowieckie 02-482
    Poland

    Site Not Available

  • Investigational Site

    Gdansk, Pomeranian Voivodeship 80-546
    Poland

    Active - Recruiting

  • Investigational Site

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-546
    Poland

    Site Not Available

  • Investigational Site

    Gdańsk, Pomorskie 80-546
    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

    Katowice, Silesian Voivodeship 40-600
    Poland

    Active - Recruiting

  • Investigational Site

    Sosnowiec, Silesian Voivodeship 41-218
    Poland

    Active - Recruiting

  • Investigational Site

    Katowice 3096472, Silesian Voivodeship 3337497 40-600
    Poland

    Site Not Available

  • Investigational Site

    Sosnowiec 3085128, Silesian Voivodeship 3337497 41-218
    Poland

    Site Not Available

  • Investigational Site

    Krakow, Woj. Małopolskie 30-727
    Poland

    Active - Recruiting

  • Investigational Site

    Krakow 3094802, Woj. Małopolskie 30-727
    Poland

    Site Not Available

  • Investigational Site

    Kraków, Woj. Małopolskie 30-727
    Poland

    Site Not Available

  • Investigational Site #20

    Kraków, Woj. Małopolskie 30-727
    Poland

    Site Not Available

  • Investigational Site

    Lodz, 90-237
    Poland

    Active - Recruiting

  • Investigational Site

    Lodz 3093133, 90-237
    Poland

    Site Not Available

  • Investigational Site

    Łódź, 90-237
    Poland

    Site Not Available

  • Investigational Site #21

    Łódź, 90-237
    Poland

    Site Not Available

  • Investigational Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Investigational Site #25

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Investigational Site

    Los Angeles, California 90024
    United States

    Active - Recruiting

  • Investigational Site

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Investigational Site

    Los Angeles 5368361, California 5332921 90024
    United States

    Site Not Available

  • Investigational Site

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site #1

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Investigational Site

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Investigational Site #22

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Investigational Site

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Investigational Site

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Investigational Site

    Margate 4163407, Florida 4155751 33063
    United States

    Site Not Available

  • Investigational Site

    Douglasville, Georgia 30135
    United States

    Active - Recruiting

  • Investigational Site

    Douglasville 4191955, Georgia 4197000 30135
    United States

    Site Not Available

  • Investigational Site

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Investigational Site

    Skokie 4911600, Illinois 4896861 60077
    United States

    Site Not Available

  • Investigational Site

    Bowling Green, Kentucky 42101
    United States

    Active - Recruiting

  • Investigational Site

    Bowling Green 4285268, Kentucky 6254925 42101
    United States

    Site Not Available

  • Investigational Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Investigational Site #28

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Investigational Site

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Investigational Site #4

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Investigational Site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Investigational Site

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Investigational Site

    New York, New York 10023
    United States

    Active - Recruiting

  • Investigational Site

    New York 5128581, New York 5128638 10023
    United States

    Site Not Available

  • Investigational Site

    Wilmington, North Carolina 28403
    United States

    Active - Recruiting

  • Investigational Site #29

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Investigational Site

    Wilmington 4499379, North Carolina 4482348 28403
    United States

    Site Not Available

  • Investigational Site

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Investigational Site #32

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Investigational Site

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Investigational Site #27

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Investigational Site

    Boardman 5147784, Ohio 5165418 44512
    United States

    Site Not Available

  • Investigational Site

    Mason 4517698, Ohio 5165418 45040
    United States

    Site Not Available

  • Investigational Site

    Portland, Oregon 97223
    United States

    Active - Recruiting

  • Investigational Site #31

    Portland, Oregon 97223
    United States

    Site Not Available

  • Investigational Site

    Portland 5746545, Oregon 5744337 97223
    United States

    Site Not Available

  • Investigational Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Investigational Site

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Investigational Site #23

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Investigational Site

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Site Not Available

  • Investigational Site

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Investigational Site

    Frisco, Texas 75235
    United States

    Active - Recruiting

  • Investigational Site #30

    Frisco, Texas 75235
    United States

    Site Not Available

  • Investigational Site

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Investigational Site #26

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Investigational Site

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Investigational Site

    Frisco 4692559, Texas 4736286 75235
    United States

    Site Not Available

  • Investigational Site

    San Antonio 4726206, Texas 4736286 78213
    United States

    Site Not Available

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