NCT05205070

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: AnaptysBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
BIOLOGICAL	Rosnilimab	humanized monoclonal antibody
BIOLOGICAL	Placebo	Placebo solution

Timeline

• Start date: 2021-12-22
• Primary completion: 2023-01-19
• Completion: 2023-03-19
• First posted: 2022-01-24
• Last updated: 2022-05-10

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study