A Study Evaluating APG777 in Atopic Dermatitis

NCT06395948 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: APG777-201
• Study Type: interventional
• Target: 470
• Locations: 9 countries
• Sites: 94

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; APG777; Safety; Efficacy

Outcome Measures

Primary Outcomes (2)

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

  Baseline and at Week 16

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

  At Week 16

Secondary Outcomes (14)

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

  Up to 106 Weeks

• Part A and B: Change from Baseline in EASI

  Baseline, through Week 16 and at Week 52

• Part A and B: Percent Change from Baseline in EASI

  Baseline through Week 16 and at Week 52

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

  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

  Baseline through Week 16 and at Week 52

Study Arms (6)

Part A: Induction Period: APG777

EXPERIMENTAL

Participants will receive APG777 per protocol defined dosing regimen

Drug: APG777

Part A: Induction Period: Placebo

PLACEBO COMPARATOR

Participants will receive matching Placebo injections per protocol defined dosing regimen

Drug: Placebo

Part A: Maintenance Period: APG777

EXPERIMENTAL

Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen

Drug: APG777

Part B: Induction Period: APG777

EXPERIMENTAL

Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen

Drug: APG777

Part B: Induction Period: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo injections per protocol defined dosing regimen

Drug: Placebo

Part B: Maintenance Period: APG777

EXPERIMENTAL

Participants will receive APG777 per protocol defined dosing regimen

Drug: APG777

Interventions

APG777 DRUG

APG777 subcutaneous injection

Part A: Induction Period: APG777; Part A: Maintenance Period: APG777; Part B: Induction Period: APG777; Part B: Maintenance Period: APG777

Placebo DRUG

Matching placebo subcutaneous injection

Part A: Induction Period: Placebo; Part B: Induction Period: Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apogee Therapeutics, Inc.: lead

Study Sites (94)

Investigational Site

Fountain Valley, California, 92708, United States

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Los Angeles, California, 90024, United States

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San Diego, California, 92123, United States

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New Haven, Connecticut, 06519, United States

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Coral Gables, Florida, 33134, United States

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Jacksonville, Florida, 32256, United States

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Margate, Florida, 33063, United States

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Douglasville, Georgia, 30135, United States

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Chicago, Illinois, 60657, United States

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Skokie, Illinois, 60077, United States

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West Lafayette, Indiana, 47906, United States

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Bowling Green, Kentucky, 42104, United States

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Rockville, Maryland, 20850, United States

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Detroit, Michigan, 48202, United States

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Troy, Michigan, 48084, United States

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Portsmouth, New Hampshire, 13801, United States

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New York, New York, 10023, United States

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Wilmington, North Carolina, 28403, United States

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Boardman, Ohio, 44512, United States

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Mason, Ohio, 45040, United States

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Portland, Oregon, 97201, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37215, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75235, United States

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San Antonio, Texas, 78213, United States

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Norfolk, Virginia, 23502, United States

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Mill Creek, Washington, 98012, United States

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Calgary, Alberta, T2J 7E1, Canada

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Calgary, Alberta, T3E 0B2, Canada

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Edmonton, Alberta, T5J 3S9, Canada

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Vancouver, British Columbia, V5Z 4E8, Canada

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Winnipeg, Manitoba, R3M 3Z4, Canada

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Fredericton, New Brunswick, E3B 1G9, Canada

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Ajax, Ontario, L1S 7K8, Canada

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Markham, Ontario, L3P 1X3, Canada

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Mississauga, Ontario, L4Y 4C5, Canada

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Ottawa, Ontario, K1K 4L2, Canada

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Peterborough, Ontario, K9J 5K2, Canada

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Toronto, Ontario, M3B 0A7, Canada

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Toronto, Ontario, M4E 2Y9, Canada

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Toronto, Ontario, M4W 2N4, Canada

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Montreal, Quebec, H2X 2V1, Canada

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Québec, Quebec, G1V4X7, Canada

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Prague, 10000, Czechia

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Prague, 10034, Czechia

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Prague, 11000, Czechia

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Prague, 15006, Czechia

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Prague, 16000, Czechia

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Rouen, Normandy, 76031, France

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Martigues, 13500, France

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Nantes, 44093, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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Augsburg, Bavaria, 86179, Germany

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München, Bavaria, 81377, Germany

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Blankenfelde-Mahlow, Brandenburg, 15831, Germany

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Darmstadt, Hesse, 64283, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Bad Bentheim, Lower Saxony, 48455, Germany

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Münster, North Rhine Westfalia, 48149, Germany

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Dresden, Saxony, 01307, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Lübeck, Schleswig-Holstein, 23538, Germany

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Berlin, 10117, Germany

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Hamburg, 20246, Germany

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Hamburg, 20354, Germany

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Debrecen, Hajdú-Bihar, 4032, Hungary

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Budapest, 1085, Hungary

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Szeged, 6720, Hungary

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Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

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Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

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Lublin, Lublin Voivodeship, 20-573, Poland

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Warsaw, Masovian Voivodeship, 01-595, Poland

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Warsaw, Masovian Voivodeship, 02-482, Poland

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Gdansk, Pomeranian Voivodeship, 80-546, Poland

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Katowice, Silesian Voivodeship, 40-600, Poland

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Sosnowiec, Silesian Voivodeship, 41-218, Poland

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Szczecin, West Pomeranian Voivodeship, 71-500, Poland

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Krakow, Woj. Małopolskie, 30-727, Poland

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Lodz, Łódź Voivodeship, 90-338, Poland

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Santiago de Compostela, A Coruña, 15706, Spain

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Badalona, Barcelona, 08916, Spain

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Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

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Alicante, 03010, Spain

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Barcelona, 08041, Spain

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Madrid, 28006, Spain

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Madrid, 28040, Spain

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Zaragoza, 50009, Spain

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Salford, Greater Manchester, M6 8HD, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

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London, SE1 9RT, United Kingdom

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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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor's study staff will also be blinded in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5); ES (8); CA (16); HU (3); US (29); DE (16); PL (11); FR (3); GB (3)