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NCT03532958 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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