A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata
NCT ID: NCT05205070
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2021-12-22
2023-03-19
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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Rosnilimab (ANB030)
ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks
Rosnilimab
humanized monoclonal antibody
Placebo solution
Placebo solution, SC injections every 4 weeks
Placebo
Placebo solution
Interventions
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Rosnilimab
humanized monoclonal antibody
Placebo
Placebo solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is \> 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).
Exclusion Criteria
* Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
* Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).
18 Years
75 Years
ALL
No
Sponsors
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AnaptysBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Randazzo, MD
Role: STUDY_DIRECTOR
AnaptysBio, Inc.
Locations
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10-105
Birmingham, Alabama, United States
Site10-103
Encinitas, California, United States
Site 10-113
Northridge, California, United States
Site 10-115
Chicago, Illinois, United States
10-104
Indianapolis, Indiana, United States
Site 10-109
Plainfield, Indiana, United States
Site 10-116
Louisville, Kentucky, United States
Site 10-117
Clarkston, Michigan, United States
Site 10-111
New York, New York, United States
Site 10-101
Charlotte, North Carolina, United States
Site 10-102
Bexley, Ohio, United States
Site 10-106
Tulsa, Oklahoma, United States
10-107
Upper Saint Clair, Pennsylvania, United States
10-110
Houston, Texas, United States
Site 10-108
San Antonio, Texas, United States
Site 10-114
Kenosha, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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ANB030-201
Identifier Type: -
Identifier Source: org_study_id
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