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

Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
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Fountain Valley
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Los Angeles
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San Diego
Connecticut
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New Haven
Florida
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Coral Gables
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Jacksonville
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Margate
Georgia
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Douglasville
Illinois
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Chicago
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Skokie
Indiana
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West Lafayette
Kentucky
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Bowling Green
Maryland
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Rockville
Michigan
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Detroit
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Troy
North Carolina
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Wilmington
New Hampshire
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Portsmouth
New York
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New York
Ohio
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Boardman
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Mason
Oregon
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Portland
Pennsylvania
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Pittsburgh
South Carolina
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Charleston
Tennessee
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Nashville
Texas
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Dallas
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Dallas
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San Antonio
Virginia
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Norfolk
Washington
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Mill Creek
Other Locations
Canada
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Ajax
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Calgary
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Calgary
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Edmonton
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Fredericton
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Markham
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Mississauga
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Montreal
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Ottawa
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Peterborough
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Québec
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Toronto
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Toronto
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Toronto
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Vancouver
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Winnipeg
France
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Martigues
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Nantes
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Rouen
Germany
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Augsburg
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Bad Bentheim
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Berlin
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Blankenfelde-mahlow
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Darmstadt
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Dresden
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Frankfurt Am Main
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Freiburg Im Breisgau
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Hamburg
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Heidelberg
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Kiel
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Lübeck
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München
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Münster
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Tübingen
Hungary
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Budapest
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Debrecen
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Szeged
Poland
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Gdansk
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Katowice
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Krakow
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Lodz
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Lublin
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Sosnowiec
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Szczecin
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Warsaw
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Warsaw
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Wroclaw
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Wroclaw
Spain
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Alicante
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Badalona
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Barcelona
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Las Palmas De Gran Canaria
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Madrid
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Madrid
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Santiago De Compostela
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Zaragoza
United Kingdom
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Dudley
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London
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Salford
Contact Information
Primary
Study Director
ClinicalTrials@apogeetherapeutics.com
+1 781 208 2408
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2028-06
Participants
Target number of participants: 431
Treatments
Experimental: Part A: Induction Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
Placebo_comparator: Part A: Induction Period: Placebo
Participants will receive matching Placebo injections per protocol defined dosing regimen
Experimental: Part A: Maintenance Period: APG777
Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
Experimental: Part B: Induction Period: APG777
Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
Placebo_comparator: Part B: Induction Period: Placebo
Participants will receive matching placebo injections per protocol defined dosing regimen
Experimental: Part B: Maintenance Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
Related Therapeutic Areas
Sponsors
Leads: Apogee Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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