Recruiting

Phase 2

APG777A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

Sponsor:

Apogee Therapeutics, Inc.

Code:

NCT07003425

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APG777

Study Details

Brief 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.

Conditions

Atopic Dermatitis

Study ID

NCT07003425

Start date

May 14, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: APG777 - Long Term Extension Treatment - 12 Weeks

Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

experimental: APG777 - Long Term Extension Treatment - 24 Weeks

Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

experimental: APG777 - Open Label Escape Arm

Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.

Interventions

APG777

APG777 subcutaneous injection

APG777

APG777 subcutaneous injection every 12 weeks

APG777

APG777 subcutaneous injection every 24 weeks

Primary outcome measure

Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Study Director

7812082408 ClinicalTrials@apogeetherapeutics.com

Locations

Investigational Site

Recruiting

Fountain Valley, California, United States, 92708

Investigational Site

Recruiting

Los Angeles, California, United States, 90024

Investigational Site

Recruiting

Coral Gables, Florida, United States, 33134

Investigational Site

Recruiting

Jacksonville, Florida, United States, 32256

Investigational Site

Recruiting

Margate, Florida, United States, 33063

Investigational Site

Recruiting

Douglasville, Georgia, United States, 30135

Investigational Site

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Skokie, Illinois, United States, 60077

Investigational Site

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Bowling Green, Kentucky, United States, 42101

Investigational Site

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Detroit, Michigan, United States, 48202

Investigational Site

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Troy, Michigan, United States, 48084

Investigational Site

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New York, New York, United States, 10023

Investigational Site

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Wilmington, North Carolina, United States, 28403

Investigational Site

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Boardman, Ohio, United States, 44512

Investigational Site

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Mason, Ohio, United States, 45040

Investigational Site

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Portland, Oregon, United States, 97223

Investigational Site

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Pittsburgh, Pennsylvania, United States, 15213

Investigational Site

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Charleston, South Carolina, United States, 29425

Investigational Site

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Nashville, Tennessee, United States, 37215

Investigational Site

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Dallas, Texas, United States, 75230

Investigational Site

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Frisco, Texas, United States, 75235

Investigational Site

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San Antonio, Texas, United States, 78213

Investigational Site

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Mill Creek, Washington, United States, 98012

Investigational Site

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Calgary, Alberta, Canada, T2J 7E1

Investigational Site

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Calgary, Alberta, Canada, T3E 0B2

Investigational Site

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Edmonton, Alberta, Canada, T5J 3S9

Investigational Site

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Vancouver, British Columbia, Canada, V5Z 4E8

Investigational Site

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Fredericton, Brunswick, Canada, E3B 1G9

Investigational Site

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Ajax, Ontario, Canada, L1S 7K8

Investigational Site

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Markham, Ontario, Canada, L3P 1X3

Investigational Site

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Mississauga, Ontario, Canada, L4Y 4C5

Investigational Site

Recruiting

Ottawa, Ontario, Canada, K1K 4L2

Investigational Site

Recruiting

Peterborough, Ontario, Canada, K9J 5K2

Investigational Site

Recruiting

Toronto, Ontario, Canada, M3B 0A7

Investigational Site

Recruiting

Toronto, Ontario, Canada, M4E 2Y9

Investigational Site

Recruiting

Toronto, Ontario, Canada, M4W 2N4

Investigational Site

Recruiting

Montreal, Quebec, Canada, H2X 2V1

Investigational Site

Recruiting

Québec, Quebec, Canada, G1V 4X7

More Information

Sponsor

Apogee Therapeutics, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

Atopic Dermatitis
APG777
Safety
Efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Apogee Therapeutics, Inc. on 2026-08-21.