A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
NCT ID: NCT03633396
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2019-05-20
2021-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive placebo administered by subcutaneous injection on Day 1 followed by monthly doses of placebo by subcutaneous injection on Days 29, 57, and 85.
Placebo
Administered by subcutaneous injection once a month
imsidolimab
Participants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.
Imsidolimab
Administered by subcutaneous injection once a month
Interventions
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Imsidolimab
Administered by subcutaneous injection once a month
Placebo
Administered by subcutaneous injection once a month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease duration of at least 6 months prior to screening
* Present with active pustules on palms or/and soles at screening
Exclusion Criteria
* History of recurrent or active/serious 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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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Phoenix, Arizona, United States
Investigational Site
Encino, California, United States
Investigational Site
Santa Monica, California, United States
Investigational Site
Fort Lauderdale, Florida, United States
Investigational Site
Miami, Florida, United States
Investigational Site
Pembroke Pines, Florida, United States
Investigational Site
Tampa, Florida, United States
Investigational Site
Indianapolis, Indiana, United States
Investigational Site
Plainfield, Indiana, United States
Investigational Site
Overland Park, Kansas, United States
Investigational Site
Ann Arbor, Michigan, United States
Investigational Site
St Louis, Missouri, United States
Investigational Site
St Louis, Missouri, United States
Investigational Site
Wilmington, North Carolina, United States
Investigational Site
Columbus, Ohio, United States
Investigational Site
Norman, Oklahoma, United States
Investigational Site
Portland, Oregon, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
Surrey, British Columbia, Canada
Investigational Site
Greater Sudbury, Ontario, Canada
Investigational Site
Markham, Ontario, Canada
Investigational Site
Drummondville, Quebec, Canada
Investigational Site
Montreal, Quebec, Canada
Investigational Site
Bad Bentheim, , Germany
Investigational Site
Berlin, , Germany
Investigational Site
Berlin, , Germany
Investigational Site
Bonn, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Schwerin, , Germany
Investigational Site
Gdansk, , Poland
Investigational Site
Katowice, , Poland
Investigational Site
Lodz, , Poland
Investigational Site
Olsztyn, , Poland
Investigational Site
Ostrowiec Świętokrzyski, , Poland
Investigational Site
Rzeszów, , Poland
Investigational Site
Szczecin, , Poland
Investigational Site
Wroclaw, , Poland
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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2017-004022-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB019-003
Identifier Type: -
Identifier Source: org_study_id
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