A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
NCT ID: NCT04856917
Last Updated: 2025-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2021-05-15
2022-03-29
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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Imsidolimab 400/200 mg
Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.
Imsidolimab
Humanized Monoclonal Antibody
Imsidolimab 200/100 mg
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
Imsidolimab
Humanized Monoclonal Antibody
Placebo
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
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
* Facial IGA) score of 3 (moderate) or 4 (severe)
* At least 20 and no more than 100 inflammatory lesions on the face
* No more than 100 non-inflammatory lesions on the face.
* No more than 5 nodules (≥5 millimeter \[mm\]) on the face
Exclusion Criteria
12 Years
45 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Site 10-114
Hot Springs, Arkansas, United States
Site 10-111
Fountain Valley, California, United States
Site 10-106
Sherman Oaks, California, United States
Site 10-113
Sweetwater, Florida, United States
Site 10-108
Tampa, Florida, United States
Site 10-107
Tampa, Florida, United States
Site 10-109
New Orleans, Louisiana, United States
Site 10-112
New Orleans, Louisiana, United States
Site 10-104
Detroit, Michigan, United States
Site 10-110
Portsmouth, New Hampshire, United States
Site 10-105
Murfreesboro, Tennessee, United States
Site 10-103
Austin, Texas, United States
Site 10-102
College Station, Texas, United States
Site 10-101
San Antonio, Texas, United States
Site 10-115
Waterloo, Ontario, Canada
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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ANB019-209
Identifier Type: -
Identifier Source: org_study_id
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