Clinical trial NCT05205070: A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: PD-1 receptor
Rosnilimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 10-105
state: Alabama
city: Encinitas
country: United States
facility: Site10-103
state: California
city: Northridge
country: United States
facility: Site 10-113
state: California
city: Chicago
country: United States
facility: Site 10-115
state: Illinois
city: Indianapolis
country: United States
facility: 10-104
state: Indiana
city: Plainfield
country: United States
facility: Site 10-109
state: Indiana
city: Louisville
country: United States
facility: Site 10-116
state: Kentucky
city: Clarkston
country: United States
facility: Site 10-117
state: Michigan
city: New York
country: United States
facility: Site 10-111
state: New York
city: Charlotte
country: United States
facility: Site 10-101
state: North Carolina
city: Bexley
country: United States
facility: Site 10-102
state: Ohio
city: Tulsa
country: United States
facility: Site 10-106
state: Oklahoma
city: Upper Saint Clair
country: United States
facility: 10-107
state: Pennsylvania
city: Houston
country: United States
facility: 10-110
state: Texas
city: San Antonio
country: United States
facility: Site 10-108
state: Texas
city: Kenosha
country: United States
facility: Site 10-114
state: Wisconsin
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: