A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
NCT ID: NCT04697069
Last Updated: 2025-09-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2021-05-04
2021-12-13
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
QUADRUPLE
Study Groups
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ANB019
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Imsidolimab
Humanized monoclonal antibody
Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Placebo
Placebo
Interventions
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Imsidolimab
Humanized monoclonal antibody
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is treated with an oral or injectable Food and Drug Administration (FDA)-approved EGFRi or MEKi therapy
* Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory lesions on the face at screening and Day 1.
Exclusion Criteria
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
Tampa, Florida, United States
Site 106
Boston, Massachusetts, United States
Site 101
St Louis, Missouri, United States
Site 105
Columbus, Ohio, United States
Site 103
Houston, Texas, United States
Site 302
New Town, Praha 2, Czechia
Site 303
Brno, , Czechia
Site 301
Olomouc, , Czechia
Site 304
Plzen-Bory, , Czechia
Site 404
Batumi, , Georgia
Site 402
Tbilisi, , Georgia
Site 403
Tbilisi, , Georgia
Site 405
Tbilisi, , Georgia
Site 401
Tbilisi, , Georgia
Site 601
Riga, , Latvia
Site 204
Gliwice, , Poland
Site 203
Poznan, , Poland
Site 201
Szczecin, , 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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2020-003494-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB019-207
Identifier Type: -
Identifier Source: org_study_id
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