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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects With Alopecia Areata

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

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Biological: Rosnilimab; Biological: Placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AnaptysBio Inc.; Phone Number: (858)362-6295; Email: clinicaltrialinfo@anaptysbio.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • 10-105
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • Site10-103
    • Northridge, California, United States, 91324
      • Recruiting
      • Site 10-113
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Site 10-115
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • 10-104
    • Plainfield, Indiana, United States, 46168
      • Recruiting
      • Site 10-109
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Site 10-116
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Site 10-117
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Site 10-111
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Recruiting
      • Site 10-101
  • Ohio
    • Bexley, Ohio, United States, 43208
      • Recruiting
      • Site 10-102
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Site 10-106
  • Pennsylvania
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Recruiting
      • 10-107
  • Texas
    • Houston, Texas, United States, 77056
      • Recruiting
      • 10-110
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Site 10-108
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Recruiting
      • Site 10-114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosnilimab (ANB030); ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks	Biological: Rosnilimab; humanized monoclonal antibody; Other Names: ANB030
Placebo Comparator: Placebo solution; Placebo solution, SC injections every 4 weeks	Biological: Placebo; Placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24	Week 24

Collaborators and Investigators

• Sponsor: AnaptysBio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Anticipated): January 19, 2023
• Study Completion (Anticipated): March 19, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: PD-1 receptor; Rosnilimab
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: ANB030-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No