NCT03532958

Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Equillium · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to characterize the efficacy and safety of BNZ-1 administered by slow IV push weekly for 3 months to adults diagnosed with moderate to severe alopecia areata, defined as having a \>50% loss of terminal hair on the scalp. The study has three periods: * 30-Day Screening Period * 3-Month Treatment Period * 3-Month Follow-up Period The study will be conducted at approximately 15-20 clinical sites in the United States.

Conditions

• Alopecia Areata
• Alopecia Totalis
• Alopecia Universalis

Interventions

Type	Name	Description
DRUG	BNZ-1	PEGylated peptide inhibitor of IL-2, IL-9, and IL-15
DRUG	Normal saline	Dose volume consistent with weight-based dosing of BNZ-1

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2018-05-22
• Last updated: 2022-09-16

Regulatory

• FDA-regulated drug study