Recruiting
Phase 2

Rosnilimab

Sponsor:

AnaptysBio, Inc.

Code:

NCT05205070

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rosnilimab

Placebo

Study Details

Brief summary:

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

Conditions

Alopecia Areata

Study ID

NCT05205070

Start date

Dec 22, 2021

Status verified date

May, 2022

Completion date

Mar 19, 2023

Anticipated

Primary completion date

Jan 19, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rosnilimab (ANB030)

ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks

placebo comparator: Placebo solution

Placebo solution, SC injections every 4 weeks

Interventions

Rosnilimab

humanized monoclonal antibody

Placebo

Placebo solution

Primary outcome measure

  • Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

AnaptysBio Inc.

(858)362-6295clinicaltrialinfo@anaptysbio.com

Locations

10-105

Recruiting

Birmingham, Alabama, United States, 35205

Site10-103

Recruiting

Encinitas, California, United States, 92024

Site 10-113

Recruiting

Northridge, California, United States, 91324

Site 10-115

Recruiting

Chicago, Illinois, United States, 60611

10-104

Recruiting

Indianapolis, Indiana, United States, 46250

Site 10-109

Recruiting

Plainfield, Indiana, United States, 46168

Site 10-116

Recruiting

Louisville, Kentucky, United States, 40241

Site 10-117

Recruiting

Clarkston, Michigan, United States, 48346

Site 10-111

Recruiting

New York, New York, United States, 10029

Site 10-101

Recruiting

Charlotte, North Carolina, United States, 28277

Site 10-102

Recruiting

Bexley, Ohio, United States, 43208

Site 10-106

Recruiting

Tulsa, Oklahoma, United States, 74136

10-107

Recruiting

Upper Saint Clair, Pennsylvania, United States, 15241

10-110

Recruiting

Houston, Texas, United States, 77056

Site 10-108

Recruiting

San Antonio, Texas, United States, 78229

Site 10-114

Recruiting

Kenosha, Wisconsin, United States, 53144

More Information

Sponsor

AnaptysBio, Inc.

Last update posted

May 10, 2022

Last verified

May, 2022

Keywords

  • PD-1 receptor
  • Rosnilimab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AnaptysBio, Inc. on 2022-05-10.