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

Alopecia Areata Clinical Trial

— AZURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205070
• Other study ID #: ANB030-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2021
• Est. completion date: March 19, 2023

Study information

• Verified date: May 2022
• Source: AnaptysBio, Inc.
• Contact: AnaptysBio Inc.
• Phone: (858)362-6295
• Email: clinicaltrialinfo[@]anaptysbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Biological:
• Rosnilimab
humanized monoclonal antibody
• Placebo
Placebo solution

Locations

Country	Name	City	State
United States	Site 10-102	Bexley	Ohio
United States	10-105	Birmingham	Alabama
United States	Site 10-101	Charlotte	North Carolina
United States	Site 10-115	Chicago	Illinois
United States	Site 10-117	Clarkston	Michigan
United States	Site10-103	Encinitas	California
United States	10-110	Houston	Texas
United States	10-104	Indianapolis	Indiana
United States	Site 10-114	Kenosha	Wisconsin
United States	Site 10-116	Louisville	Kentucky
United States	Site 10-111	New York	New York
United States	Site 10-113	Northridge	California
United States	Site 10-109	Plainfield	Indiana
United States	Site 10-108	San Antonio	Texas
United States	Site 10-106	Tulsa	Oklahoma
United States	10-107	Upper Saint Clair	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24		Week 24