A Study Evaluating APG777 in Atopic Dermatitis

May 6, 2026 updated by: Apogee Therapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Investigational Site
      • Calgary, Alberta, Canada, T3E 0B2
        • Investigational Site
      • Edmonton, Alberta, Canada, T5J 3S9
        • Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • Investigational Site
      • Markham, Ontario, Canada, L3P 1X3
        • Investigational Site
      • Mississauga, Ontario, Canada, L4Y 4C5
        • Investigational Site
      • Ottawa, Ontario, Canada, K1K 4L2
        • Investigational Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Investigational Site
      • Toronto, Ontario, Canada, M3B 0A7
        • Investigational Site
      • Toronto, Ontario, Canada, M4E 2Y9
        • Investigational Site
      • Toronto, Ontario, Canada, M4W 2N4
        • Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Investigational Site
      • Québec, Quebec, Canada, G1V4X7
        • Investigational Site
  • Czechia
      • Prague, Czechia, 10000
        • Investigational Site
      • Prague, Czechia, 10034
        • Investigational Site
      • Prague, Czechia, 11000
        • Investigational Site
      • Prague, Czechia, 15006
        • Investigational Site
      • Prague, Czechia, 16000
        • Investigational Site
  • France
      • Martigues, France, 13500
        • Investigational Site
      • Nantes, France, 44093
        • Investigational Site
    • Normandy
      • Rouen, Normandy, France, 76031
        • Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Investigational Site
      • Hamburg, Germany, 20354
        • Investigational Site
      • Hamburg, Germany, 20246
        • Investigational Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79104
        • Investigational Site
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Investigational Site
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Investigational Site
    • Bavaria
      • Augsburg, Bavaria, Germany, 86179
        • Investigational Site
      • München, Bavaria, Germany, 81377
        • Investigational Site
    • Brandenburg
      • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
        • Investigational Site
    • Hesse
      • Darmstadt, Hesse, Germany, 64283
        • Investigational Site
      • Frankfurt am Main, Hesse, Germany, 60590
        • Investigational Site
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Investigational Site
    • North Rhine Westfalia
      • Münster, North Rhine Westfalia, Germany, 48149
        • Investigational Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Investigational Site
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Investigational Site
  • Hungary
      • Budapest, Hungary, 1085
        • Investigational Site
      • Szeged, Hungary, 6720
        • Investigational Site
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Investigational Site
  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-450
        • Investigational Site
      • Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
        • Investigational Site
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-573
        • Investigational Site
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-595
        • Investigational Site
      • Warsaw, Masovian Voivodeship, Poland, 02-482
        • Investigational Site
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Investigational Site
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-600
        • Investigational Site
      • Sosnowiec, Silesian Voivodeship, Poland, 41-218
        • Investigational Site
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
        • Investigational Site
    • Woj. Małopolskie
      • Krakow, Woj. Małopolskie, Poland, 30-727
        • Investigational Site
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-338
        • Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Investigational Site
      • Barcelona, Spain, 08041
        • Investigational Site
      • Madrid, Spain, 28006
        • Investigational Site
      • Madrid, Spain, 28040
        • Investigational Site
      • Zaragoza, Spain, 50009
        • Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Investigational Site
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
        • Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Investigational Site
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Investigational Site
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Investigational Site
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Investigational Site
      • Los Angeles, California, United States, 90024
        • Investigational Site
      • San Diego, California, United States, 92123
        • Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Investigational Site
      • Margate, Florida, United States, 33063
        • Investigational Site
    • Georgia
      • Douglasville, Georgia, United States, 30135
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Investigational Site
      • Skokie, Illinois, United States, 60077
        • Investigational Site
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigational Site
      • Troy, Michigan, United States, 48084
        • Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 13801
        • Investigational Site
    • New York
      • New York, New York, United States, 10023
        • Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Investigational Site
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Investigational Site
      • Mason, Ohio, United States, 45040
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201
        • Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Investigational Site
      • Dallas, Texas, United States, 75230
        • Investigational Site
      • San Antonio, Texas, United States, 78213
        • Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Investigational Site
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Induction Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
Drug: APG777
APG777 subcutaneous injection
Placebo Comparator: Part A: Induction Period: Placebo
Participants will receive matching Placebo injections per protocol defined dosing regimen
Drug: Placebo
Matching placebo subcutaneous injection
Experimental: Part A: Maintenance Period: APG777
Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
Drug: APG777
APG777 subcutaneous injection
Experimental: Part B: Induction Period: APG777
Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
Drug: APG777
APG777 subcutaneous injection
Placebo Comparator: Part B: Induction Period: Placebo
Participants will receive matching placebo injections per protocol defined dosing regimen
Drug: Placebo
Matching placebo subcutaneous injection
Experimental: Part B: Maintenance Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
Drug: APG777
APG777 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Time Frame: Baseline and at Week 16
Baseline and at Week 16
Part B: Proportion of participants who achieve EASI 75 at Week 16
Time Frame: At Week 16
At Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 106 Weeks
Up to 106 Weeks
Part A and B: Change from Baseline in EASI
Time Frame: Baseline, through Week 16 and at Week 52
Baseline, through Week 16 and at Week 52
Part A and B: Percent Change from Baseline in EASI
Time Frame: Baseline through Week 16 and at Week 52
Baseline through Week 16 and at Week 52
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
Baseline through Week 16 and at Week 52
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
Baseline through Week 16 and at Week 52
Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement
Time Frame: Baseline through Week 16 and at Week 52
Baseline through Week 16 and at Week 52
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
Baseline through Week 16 and at Week 52
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
Baseline through Week 16 and at Week 52
Part A and B: Serum Concentrations of APG777 Over Time
Time Frame: Up to 106 Weeks
Up to 106 Weeks
Part A and B: Predose Serum Concentrations of APG777 (Ctrough)
Time Frame: Up to 106 Weeks
Up to 106 Weeks
Part A and B: Maximum concentration (Cmax) of APG777
Time Frame: Up to 106 Weeks
Up to 106 Weeks
Part A and B: Time to reach Cmax (tmax)
Time Frame: Up to 106 Weeks
Up to 106 Weeks
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
Baseline to 16 Weeks
Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period
Time Frame: 16 Weeks to 52 Weeks
16 Weeks to 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apogee Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APG777-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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