NCT05205070

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2023

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

January 11, 2022

Last Update Submit

May 5, 2022

Conditions

Alopecia Areata

Keywords

PD-1 receptorRosnilimab

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24

    Week 24

Study Arms (2)

Rosnilimab (ANB030)

EXPERIMENTAL

ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks

Biological: Rosnilimab

Placebo solution

PLACEBO COMPARATOR

Placebo solution, SC injections every 4 weeks

Biological: Placebo

Interventions

RosnilimabBIOLOGICAL

humanized monoclonal antibody

Also known as: ANB030
Rosnilimab (ANB030)
PlaceboBIOLOGICAL

Placebo solution

Placebo solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

10-105

Birmingham, Alabama, 35205, United States

RECRUITING

Site10-103

Encinitas, California, 92024, United States

RECRUITING

Site 10-113

Northridge, California, 91324, United States

RECRUITING

Site 10-115

Chicago, Illinois, 60611, United States

RECRUITING

10-104

Indianapolis, Indiana, 46250, United States

RECRUITING

Site 10-109

Plainfield, Indiana, 46168, United States

RECRUITING

Site 10-116

Louisville, Kentucky, 40241, United States

RECRUITING

Site 10-117

Clarkston, Michigan, 48346, United States

RECRUITING

Site 10-111

New York, New York, 10029, United States

RECRUITING

Site 10-101

Charlotte, North Carolina, 28277, United States

RECRUITING

Site 10-102

Bexley, Ohio, 43208, United States

RECRUITING

Site 10-106

Tulsa, Oklahoma, 74136, United States

RECRUITING

10-107

Upper Saint Clair, Pennsylvania, 15241, United States

RECRUITING

10-110

Houston, Texas, 77056, United States

RECRUITING

Site 10-108

San Antonio, Texas, 78229, United States

RECRUITING

Site 10-114

Kenosha, Wisconsin, 53144, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bruce Randazzo, MD

    AnaptysBio, Inc.

    STUDY DIRECTOR

Central Study Contacts

AnaptysBio Inc.

CONTACT

(858)362-6295clinicaltrialinfo@anaptysbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 24, 2022

Study Start

December 22, 2021

Primary Completion

January 19, 2023

Study Completion

March 19, 2023

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(16)