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Active (not recruiting) Phase 2 NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis

Phase 2 – studying effectiveness and dosage
Conditions: Atopic Dermatitis

Sponsor: Apogee Therapeutics, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
APG777
DRUG
Placebo
DRUG
Locations 94
Canada (16)
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Ajax , Ontario
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Calgary , Alberta
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Calgary , Alberta
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Edmonton , Alberta
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Fredericton , New Brunswick
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Markham , Ontario
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Mississauga , Ontario
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Montreal , Quebec
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Ottawa , Ontario
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Peterborough , Ontario
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Québec , Quebec
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Toronto , Ontario
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Toronto , Ontario
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Toronto , Ontario
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Vancouver , British Columbia
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Winnipeg , Manitoba
Czech Republic (5)
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Prague
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Prague
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Prague
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Prague
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Prague
France (3)
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Martigues
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Nantes
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Rouen , Normandy
Germany (16)
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Augsburg , Bavaria
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Bad Bentheim , Lower Saxony
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Berlin
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Blankenfelde-Mahlow , Brandenburg
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Darmstadt , Hesse
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Dresden , Saxony
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Frankfurt am Main , Hesse
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Freiburg im Breisgau , Baden-Wurttemberg
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Hamburg
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Hamburg
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Heidelberg , Baden-Wurttemberg
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Kiel , Schleswig-Holstein
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Lübeck , Schleswig-Holstein
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München , Bavaria
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Münster , North Rhine Westfalia
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Tübingen , Baden-Wurttemberg
Hungary (3)
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Budapest
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Debrecen , Hajdú-Bihar
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Szeged
Poland (11)
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Gdansk , Pomeranian Voivodeship
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Katowice , Silesian Voivodeship
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Krakow , Woj. Małopolskie
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Lodz , Łódź Voivodeship
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Lublin , Lublin Voivodeship
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Sosnowiec , Silesian Voivodeship
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Szczecin , West Pomeranian Voivodeship
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Warsaw , Masovian Voivodeship
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Warsaw , Masovian Voivodeship
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Wroclaw , Lower Silesian Voivodeship
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Wroclaw , Lower Silesian Voivodeship
Spain (8)
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Alicante
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Badalona , Barcelona
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Barcelona
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Las Palmas de Gran Canaria , Canary Islands
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Madrid
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Madrid
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Santiago de Compostela , A Coruña
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Zaragoza
United Kingdom (3)
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Dudley , West Midlands
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London
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Salford , Greater Manchester
United States (29)
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Boardman , Ohio
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Bowling Green , Kentucky
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Charleston , South Carolina
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Chicago , Illinois
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Coral Gables , Florida
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Dallas , Texas
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Dallas , Texas
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Detroit , Michigan
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Douglasville , Georgia
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Fountain Valley , California
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Jacksonville , Florida
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Los Angeles , California
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Margate , Florida
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Mason , Ohio
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Mill Creek , Washington
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Nashville , Tennessee
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New Haven , Connecticut
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New York , New York
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Norfolk , Virginia
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Pittsburgh , Pennsylvania
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Portland , Oregon
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Portsmouth , New Hampshire
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Rockville , Maryland
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San Antonio , Texas
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San Diego , California
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Skokie , Illinois
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Troy , Michigan
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West Lafayette , Indiana
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Wilmington , North Carolina
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.04.2024
Completion date
01.06.2028
Registry ID
NCT06395948
Source
clinicaltrials.gov
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