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

AnaptysBio

Status and phase: Unknown; Phase 2

Conditions: Alopecia Areata

Treatments: Biological: Placebo; Biological: Rosnilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05205070

ANB030-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Rosnilimab (ANB030)

Experimental group

Description:

ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks

Treatment:

Biological: Rosnilimab

Placebo solution

Placebo Comparator group

Description:

Placebo solution, SC injections every 4 weeks

Treatment:

Biological: Placebo