A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
NCT ID: NCT04856930
Last Updated: 2025-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2021-07-07
2022-12-14
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 milligrams (mg)
400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks
Imsidolimab
Humanized Monoclonal Antibody
Imsidolimab 200/100 mg
400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks
Imsidolimab
Humanized Monoclonal Antibody
Placebo
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
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
2. HS lesions present in at least 2 distinct anatomical areas.
3. Total Abscess and inflammatory nodule (AN) count ≥ 5.
4. Draining fistulas less than or equal to (≤) 20.
5. Stable HS for at least 6 weeks prior to Day 1 visit.
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 10-108
Birmingham, Alabama, United States
Site 10-104
Fountain Valley, California, United States
Site 10-119
Northridge, California, United States
Site 10-102
Sacramento, California, United States
Site 10-109
Coral Gables, Florida, United States
Site 10-107
Largo, Florida, United States
Site 10-111
Tampa, Florida, United States
Site 10-110
Sandy Springs, Georgia, United States
Site 10-101
Fort Gratiot, Michigan, United States
Site 10-103
Portsmouth, New Hampshire, United States
Site 10-115
Warwick, Rhode Island, United States
Site 10-113
Greenville, South Carolina, United States
Site 10-118
Houston, Texas, United States
Site 10-112
Pflugerville, Texas, United States
Site 10-117
San Antonio, Texas, United States
Site 10-105
Norfolk, Virginia, United States
Site 10-106
Spokane, Washington, United States
Site 11-106
Calgary, Alberta, Canada
Site 11-103
Cobourg, Ontario, Canada
Site 11-102
Markham, Ontario, Canada
Site 11-105
Québec, Quebec, Canada
Site 11-101
Saint-Jérôme, Quebec, Canada
Site 59-106
Batumi, , Georgia
Site 59-102
Tbilisi, , Georgia
Site 59-104
Tbilisi, , Georgia
Site 59-103
Tbilisi, , Georgia
Site 59-105
Tbilisi, , Georgia
Site 59-107
Tbilisi, , Georgia
Site 30-107
Krakow, Malopolska, Poland
Site 30-104
Rzeszów, Podkarpackie Voivodeship, Poland
Site 30-108
Katowice, Silesian Voivodeship, Poland
Site 30-103
Ossy, Silesian Voivodeship, Poland
Site 30-109
Lodz, , Poland
Site 30-106
Olsztyn, , 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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2021-001440-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB019-208
Identifier Type: -
Identifier Source: org_study_id
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