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

NCT03532958 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: BNZ1-CT-204
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from baseline using the Severity of Alopecia Tool (SALT) score

  3 months

• Treatment-Emergent Adverse Events

  Safety profile defined as incidence, severity and relationship of treatment-emergent adverse events

  3 months

Secondary Outcomes (8)

• Alopecia Areata Investigator Global Assessment (AA-IGA)

  3 & 6 months

• Patient Global Assessment

  3 & 6 months

• Proportion of Patients with SALT50

  3 months & 6 months

• Proportion of Patients with SALT75

  3 months & 6 months

• Proportion of Patients with SALT90

  3 months & 6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Low Dose BNZ-1

EXPERIMENTAL

0.5 mg/kg QW

Drug: BNZ-1

Moderate Dose BNZ-1

EXPERIMENTAL

2 mg/kg QW

Drug: BNZ-1

Interventions

BNZ-1 DRUG

PEGylated peptide inhibitor of IL-2, IL-9, and IL-15

Low Dose BNZ-1; Moderate Dose BNZ-1

Normal saline DRUG

Dose volume consistent with weight-based dosing of BNZ-1

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a diagnosis of moderate to severe AA defined as the presence of ≥50% total terminal hair loss at baseline as measured using the SALT score for \> 6 months, but \<10 yrs. Includes Alopecia Totalis and Alopecia Universalis
• Patients may be naïve to treatment or have been treated with intralesional (IL) steroids or other treatments for AA, with a washout of at least 30 days or 5 times the elimination half-life prior to Day 1.
• Prior treatment with a janus kinase (JAK) inhibitor (e.g., tofacitinib, ruxolitnib) is allowed, but patients considered refractory to a JAK inhibitor are excluded from this trial.

You may not qualify if:

• e subjects from this study if any of the following criteria are met:
• Patients with active inflammatory skin disease on the scalp, including but not limited to psoriasis, seborrheic dermatitis or folliculitis, which cannot be adequately controlled prior to screening.
• Ongoing treatment with an immune system modulator or suppressant that cannot be discontinued prior to screening and at least 30 days or 5-times the elimination half-life prior to treatment.
• Any ongoing topical treatment for alopecia areata
• History of or currently active primary or secondary immunodeficiency.
• Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including latent tuberculosis \[TB\] unless treatment is documented or atypical mycobacterial disease \[but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions\]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 60 days of study drug administration or oral antibiotics within 30 days prior to study drug administration.
• Received other investigational products or therapy in the 60 days prior to study drug administration.

Sponsors & Collaborators

• Equillium: lead

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 22, 2018
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09