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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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

Key facts

Study ID

NCT05205070

Run by

AnaptysBio, Inc.

People needed

45

Starts

2021-12-22

Expected to finish

2023-03-19

Last updated by the study team

2022-05-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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