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NCT Number: NCT07003425

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APG777

Drug

APG777 subcutaneous injection

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events

    Time frame: Up to 3 years

Secondary outcomes

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

    Time frame: Through Extended Treatment Period, an average of 2 years

  2. 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.

    Time frame: Through Extended Treatment Period, an average of 2 years

  3. 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

    Time frame: Through Extended Treatment Period, an average of 2 years

  4. Percentage of Participants who use Rescue Therapy

    Time frame: Through Extended Treatment Period, an average of 2 years

  5. Percentage of Participants Who Continue to Exhibit EASI 75

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

    Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined

  6. Percentage of Participants Who Continue to Exhibit vIGA-AD Response

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

    Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.

  7. Percentage of Participants Who Continue to Exhibit I-NRS Response

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

    Of the participants who achieve a ≥ 4 point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined.

  8. Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs

    Time frame: Up to 3 years

  9. Serum Concentrations of APG777 Over Time

    Time frame: Up to 3 years

  10. Predose Serum Concentrations of APG777

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

7812082408

Sponsors and collaborators

Lead sponsor

Apogee Therapeutics, Inc.

Industry

Registry information

Official study title

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 4, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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