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

Phase 2

• Conditions: Alopecia Areata
• Interventions: Biological: Placebo; Biological: Rosnilimab

• Registration Number: NCT05205070
• Lead Sponsor: AnaptysBio, Inc.

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

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-10
• Primary Completion: 2023-01-19
• Study Completion: 2023-03-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo solution	Placebo	Placebo solution, SC injections every 4 weeks
Rosnilimab (ANB030)	Rosnilimab	ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24	Week 24

Trial Locations

Locations (16)

10-105; 🇺🇸 Birmingham, Alabama, United States

Site 10-111; 🇺🇸 New York, New York, United States

Site10-103; 🇺🇸 Encinitas, California, United States

Site 10-109; 🇺🇸 Plainfield, Indiana, United States

Site 10-101; 🇺🇸 Charlotte, North Carolina, United States

Site 10-113; 🇺🇸 Northridge, California, United States

Site 10-102; 🇺🇸 Bexley, Ohio, United States

10-104; 🇺🇸 Indianapolis, Indiana, United States

Site 10-115; 🇺🇸 Chicago, Illinois, United States

10-107; 🇺🇸 Upper Saint Clair, Pennsylvania, United States

Site 10-116; 🇺🇸 Louisville, Kentucky, United States

10-110; 🇺🇸 Houston, Texas, United States

Site 10-117; 🇺🇸 Clarkston, Michigan, United States

Site 10-114; 🇺🇸 Kenosha, Wisconsin, United States

Site 10-106; 🇺🇸 Tulsa, Oklahoma, United States

Site 10-108; 🇺🇸 San Antonio, Texas, United States