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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2023-03-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blinded design

Study Groups

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Rosnilimab (ANB030)

ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks

Group Type EXPERIMENTAL

Rosnilimab

Intervention Type BIOLOGICAL

humanized monoclonal antibody

Placebo solution

Placebo solution, SC injections every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo solution

Interventions

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Rosnilimab

humanized monoclonal antibody

Intervention Type BIOLOGICAL

Placebo

Placebo solution

Intervention Type BIOLOGICAL

Other Intervention Names

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ANB030

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AnaptysBio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Site10-103

Encinitas, California, United States

Site Status RECRUITING

Site 10-113

Northridge, California, United States

Site Status RECRUITING

Site 10-115

Chicago, Illinois, United States

Site Status RECRUITING

10-104

Indianapolis, Indiana, United States

Site Status RECRUITING

Site 10-109

Plainfield, Indiana, United States

Site Status RECRUITING

Site 10-116

Louisville, Kentucky, United States

Site Status RECRUITING

Site 10-117

Clarkston, Michigan, United States

Site Status RECRUITING

Site 10-111

New York, New York, United States

Site Status RECRUITING

Site 10-101

Charlotte, North Carolina, United States

Site Status RECRUITING

Site 10-102

Bexley, Ohio, United States

Site Status RECRUITING

Site 10-106

Tulsa, Oklahoma, United States

Site Status RECRUITING

10-107

Upper Saint Clair, Pennsylvania, United States

Site Status RECRUITING

10-110

Houston, Texas, United States

Site Status RECRUITING

Site 10-108

San Antonio, Texas, United States

Site Status RECRUITING

Site 10-114

Kenosha, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AnaptysBio Inc.

Role: CONTACT

(858)362-6295

Other Identifiers

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ANB030-201

Identifier Type: -

Identifier Source: org_study_id

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