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

Primary Purpose

Alopecia Areata, Alopecia Totalis, Alopecia Universalis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

BNZ-1

Normal saline

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

e subjects from this study if any of the following criteria are met:

Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator. Other active dermatologic conditions, including but not limited to vitiligo, atopic dermatitis, or non-scalp psoriasis are not exclusionary.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low Dose BNZ-1

Moderate Dose BNZ-1

Arm Description

Normal saline

0.5 mg/kg QW

2 mg/kg QW

Outcomes

Primary Outcome Measures

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

Treatment-Emergent Adverse Events

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

Secondary Outcome Measures

Alopecia Areata Investigator Global Assessment (AA-IGA)

Hair Satisfaction Scale

Patient Global Assessment

Hair satisfaction scale

Proportion of Patients with SALT50

Proportion of Patients with SALT75

Proportion of Patients with SALT90

Proportion of Patients with SALT100 (Disease-free)

Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS)

Change from Baseline on Dermatology Life Quality Index (DLQI)

Full Information

NCT ID

NCT03532958

First Posted

May 10, 2018

Last Updated

September 14, 2022

Sponsor

Equillium

1. Study Identification

Unique Protocol Identification Number

NCT03532958

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Transfer of study sponsor

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Equillium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata, Alopecia Totalis, Alopecia Universalis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline

Arm Title

Low Dose BNZ-1

Arm Type

Experimental

Arm Description

0.5 mg/kg QW

Arm Title

Moderate Dose BNZ-1

Arm Type

Experimental

Arm Description

2 mg/kg QW

Intervention Type

Drug

Intervention Name(s)

BNZ-1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

Treatment-Emergent Adverse Events

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Alopecia Areata Investigator Global Assessment (AA-IGA)

Description

Hair Satisfaction Scale

Time Frame

3 & 6 months

Title

Patient Global Assessment

Description

Hair satisfaction scale

Time Frame

3 & 6 months

Title

Proportion of Patients with SALT50

Time Frame

3 months & 6 months

Title

Proportion of Patients with SALT75

Time Frame

3 months & 6 months

Title

Proportion of Patients with SALT90

Time Frame

3 months & 6 months

Title

Proportion of Patients with SALT100 (Disease-free)

Time Frame

3 months & 6 months

Title

Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS)

Time Frame

3 months

Title

Change from Baseline on Dermatology Life Quality Index (DLQI)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: e subjects from this study if any of the following criteria are met: Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator. Other active dermatologic conditions, including but not limited to vitiligo, atopic dermatitis, or non-scalp psoriasis are not exclusionary. 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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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