Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata
Lead Sponsor:
AnaptysBio, Inc.
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata
Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA)...
Eligibility Criteria
Inclusion
- Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
- 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
- Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
- 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).
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05205070
Start Date
December 22 2021
End Date
March 19 2023
Last Update
May 10 2022
Active Locations (16)
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1
10-105
Birmingham, Alabama, United States, 35205
2
Site10-103
Encinitas, California, United States, 92024
3
Site 10-113
Northridge, California, United States, 91324
4
Site 10-115
Chicago, Illinois, United States, 60611