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

NCT07003425 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: APG777-202
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 45

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

Keywords

Atopic Dermatitis; APG777; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events

  Up to 3 years

Secondary Outcomes (10)

• Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline

  Through Extended Treatment Period, an average of 2 years

• Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline.

  Through Extended Treatment Period, an average of 2 years

• Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline

  Through Extended Treatment Period, an average of 2 years

• Percentage of Participants who use Rescue Therapy

  Through Extended Treatment Period, an average of 2 years

• Percentage of Participants Who Continue to Exhibit EASI 75

  From Week 52 up to Through Extended Treatment Period, an average of 2 years

Study Arms (3)

APG777 - Long Term Extension Treatment - 12 Weeks

EXPERIMENTAL

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).

Drug: APG777

APG777 - Long Term Extension Treatment - 24 Weeks

EXPERIMENTAL

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).

Drug: APG777

APG777 - Open Label Escape Arm

EXPERIMENTAL

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.

Drug: APG777

Interventions

APG777 DRUG

APG777 subcutaneous injection

APG777 - Open Label Escape Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 in the Parent Study through 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

Sponsors & Collaborators

• Apogee Therapeutics, Inc.: lead

Study Sites (45)

Investigational Site

Fountain Valley, California, 92708, United States

RECRUITING

Investigational Site

Los Angeles, California, 90024, United States

RECRUITING

Investigational Site

Coral Gables, Florida, 33134, United States

RECRUITING

Investigational Site

Jacksonville, Florida, 32256, United States

RECRUITING

Investigational Site

Margate, Florida, 33063, United States

RECRUITING

Investigational Site

Douglasville, Georgia, 30135, United States

RECRUITING

Investigational Site

Skokie, Illinois, 60077, United States

RECRUITING

Investigational Site

Bowling Green, Kentucky, 42101, United States

RECRUITING

Investigational Site

Detroit, Michigan, 48202, United States

RECRUITING

Investigational Site

Troy, Michigan, 48084, United States

RECRUITING

Investigational Site

New York, New York, 10023, United States

RECRUITING

Investigational Site

Wilmington, North Carolina, 28403, United States

RECRUITING

Investigational Site

Boardman, Ohio, 44512, United States

RECRUITING

Investigational Site

Mason, Ohio, 45040, United States

RECRUITING

Investigational Site

Portland, Oregon, 97223, United States

RECRUITING

Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Investigational Site

Charleston, South Carolina, 29425, United States

RECRUITING

Investigational Site

Nashville, Tennessee, 37215, United States

RECRUITING

Investigational Site

Dallas, Texas, 75230, United States

RECRUITING

Investigational Site

Frisco, Texas, 75235, United States

RECRUITING

Investigational Site

San Antonio, Texas, 78213, United States

RECRUITING

Investigational Site

Calgary, Alberta, T2J 7E1, Canada

RECRUITING

Investigational Site

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

Investigational Site

Fredericton, Brunswick, E3B 1G9, Canada

RECRUITING

Investigational Site

Ajax, Ontario, L1S 7K8, Canada

RECRUITING

Investigational Site

Markham, Ontario, L3P 1X3, Canada

RECRUITING

Investigational Site

Mississauga, Ontario, L4Y 4C5, Canada

RECRUITING

Investigational Site

Peterborough, Ontario, K9J 5K2, Canada

RECRUITING

Investigational Site

Toronto, Ontario, M3B 0A7, Canada

RECRUITING

Investigational Site

Toronto, Ontario, M4E 2Y9, Canada

RECRUITING

Investigational Site

Toronto, Ontario, M4W 2N4, Canada

RECRUITING

Investigational Site

Montreal, Quebec, H2X 2V1, Canada

RECRUITING

Investigational Site

Québec, Quebec, G1V 4X7, Canada

RECRUITING

Investigational Site

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

RECRUITING

Investigational Site

Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

RECRUITING

Investigational Site

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

RECRUITING

Investigational Site

Lublin, Lublin Voivodeship, 20-573, Poland

RECRUITING

Investigational Site

Warsaw, Masovian Voivodeship, 01-595, Poland

RECRUITING

Investigational Site

Warsaw, Masovian Voivodeship, 02-482, Poland

RECRUITING

Investigational Site

Gdansk, Pomeranian Voivodeship, 80-546, Poland

RECRUITING

Investigational Site

Katowice, Silesian Voivodeship, 40-600, Poland

RECRUITING

Investigational Site

Sosnowiec, Silesian Voivodeship, 41-218, Poland

RECRUITING

Investigational Site

Szczecin, West Pomeranian Voivodeship, 71-500, Poland

RECRUITING

Investigational Site

Krakow, Woj. Małopolskie, 30-727, Poland

RECRUITING

Investigational Site

Lodz, 90-237, Poland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Study Director

CONTACT

7812082408; ClinicalTrials@apogeetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

PL (11); US (21); DE (1); CA (12)