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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05205070

Acronym

AZURE

Enrollment

Registered

2022-01-24

Start date

2021-12-22

Completion date

2023-03-19

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Keywords

PD-1 receptor, Rosnilimab

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.

Interventions

BIOLOGICALRosnilimab

humanized monoclonal antibody

BIOLOGICALPlacebo

Placebo solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blinded design

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactAnaptysBio Inc.

clinicaltrialinfo@anaptysbio.com(858)362-6295

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026