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

NCT03532958 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Equillium

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532958 on ClinicalTrials.gov