A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
NCT ID: NCT03619902
Last Updated: 2025-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2019-01-30
2021-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imsidolimab
Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.
Imsidolimab
Humanized monoclonal antibody
Interventions
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Imsidolimab
Humanized monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
* Must be candidates for systemic therapy or phototherapy
Exclusion Criteria
* Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
* History of recurrent or chronic infection
* ongoing use of psoriasis prohibited medication
18 Years
75 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Site 102
Encino, California, United States
Site 105
Largo, Florida, United States
Site 104
Miami, Florida, United States
Site 101
Indianapolis, Indiana, United States
Site 100
Ann Arbor, Michigan, United States
Site 303
Lodz, , Poland
Site 302
Lodz, , Poland
Site 304
Olsztyn, , Poland
Site 301
Rzeszów, , Poland
Site 501
Seoul, , South Korea
Site 201
London, , United Kingdom
Site 203
Newcastle upon Tyne, , United Kingdom
Site 202
Salford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004021-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB019-002
Identifier Type: -
Identifier Source: org_study_id
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