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Active, not recruiting

NCT Number: NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit
  • Moderate-to-severe AD at Screening and Baseline visits
  • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
  • Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits.
  • Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit

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/or laser therapy that could affect AD within 4 weeks prior to Baseline visit

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

Treatment and study plan

APG777

Drug

APG777 subcutaneous injection

Placebo

Drug

Matching placebo subcutaneous injection

Primary outcomes

  1. Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)

    Time frame: Baseline and at Week 16

  2. Part B: Proportion of participants who achieve EASI 75 at Week 16

    Time frame: At Week 16

Secondary outcomes

  1. Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 106 Weeks

  2. Part A and B: Change from Baseline in EASI

    Time frame: Baseline, through Week 16 and at Week 52

  3. Part A and B: Percent Change from Baseline in EASI

    Time frame: Baseline through Week 16 and at Week 52

  4. Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score

    Time frame: Baseline through Week 16 and at Week 52

  5. Part A and B: Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >= 2-Point Reduction

    Time frame: Baseline through Week 16 and at Week 52

  6. Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement

    Time frame: Baseline through Week 16 and at Week 52

  7. Part A and B: Proportion of Participants Achieving a >= 4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS)

    Time frame: Baseline through Week 16 and at Week 52

  8. Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS

    Time frame: Baseline through Week 16 and at Week 52

  9. Part A and B: Serum Concentrations of APG777 Over Time

    Time frame: Up to 106 Weeks

  10. Part A and B: Predose Serum Concentrations of APG777 (Ctrough)

    Time frame: Up to 106 Weeks

  11. Part A and B: Maximum concentration (Cmax) of APG777

    Time frame: Up to 106 Weeks

  12. Part A and B: Time to reach Cmax (tmax)

    Time frame: Up to 106 Weeks

  13. Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period

    Time frame: Baseline to 16 Weeks

  14. Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period

    Time frame: 16 Weeks to 52 Weeks

Sponsors and collaborators

Lead sponsor

Apogee Therapeutics, Inc.

Industry

Registry information

Official study title

A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
May 2, 2024
Registry last updated
Jul 22, 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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