A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata

Last updated: May 5, 2022
Sponsor: AnaptysBio, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hair Loss

Alopecia

Treatment

N/A

Clinical Study ID

NCT05205070
ANB030-201
  • Ages 18-75
  • All Genders

Study Summary

Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) atthe time of informed consent.
  • Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and inwhich the current episode of hair loss is > 24 weeks (without evidence of spontaneousterminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline),but ≤ 8 years (from onset of current episode).

Exclusion

Exclusion Criteria:

  • Concomitant active systemic diseases (except stable thyroid diseases) that may causehair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that couldinterfere with the Investigators' ability to evaluate the subject's response totherapy.
  • Subject's cause of hair loss is indeterminable and/or in addition to AA they haveconcomitant 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 thatwould compromise the subject's immune status (eg, history of splenectomy).

Study Design

Total Participants: 45
Study Start date:
December 22, 2021
Estimated Completion Date:
March 19, 2023

Study 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).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.

Connect with a study center

  • 10-105

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Site10-103

    Encinitas, California 92024
    United States

    Active - Recruiting

  • Site 10-113

    Northridge, California 91324
    United States

    Active - Recruiting

  • Site 10-115

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • 10-104

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Site 10-109

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Site 10-116

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Site 10-117

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Site 10-111

    New York, New York 10029
    United States

    Active - Recruiting

  • Site 10-101

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • Site 10-102

    Bexley, Ohio 43208
    United States

    Active - Recruiting

  • Site 10-106

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • 10-107

    Upper Saint Clair, Pennsylvania 15241
    United States

    Active - Recruiting

  • 10-110

    Houston, Texas 77056
    United States

    Active - Recruiting

  • Site 10-108

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Site 10-114

    Kenosha, Wisconsin 53144
    United States

    Active - Recruiting

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