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Trial record 24 of 50 for:    Recruiting, Not yet recruiting, Available Studies | "Alopecia"

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

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ClinicalTrials.gov Identifier: NCT03532958
Recruitment Status : Not yet recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bioniz Therapeutics

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Alopecia Totalis Alopecia Universalis Drug: BNZ-1 Drug: Normal saline Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline
Drug: Normal saline
Random volume of 1 to 5 mL, consistent with weight-based dosing of BNZ-1

Experimental: Lowest Dose BNZ-1 Drug: BNZ-1
PEGylated peptide inhibitor of IL-2, IL-9, and IL-15

Experimental: Low Dose BNZ-1 Drug: BNZ-1
PEGylated peptide inhibitor of IL-2, IL-9, and IL-15

Experimental: Moderate Dose BNZ-1 Drug: BNZ-1
PEGylated peptide inhibitor of IL-2, IL-9, and IL-15

Experimental: High Dose BNZ-1 Drug: BNZ-1
PEGylated peptide inhibitor of IL-2, IL-9, and IL-15




Primary Outcome Measures :
  1. Change from baseline using the Severity of Alopecia Tool (SALT) score [ Time Frame: 3 months ]
  2. Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
    Safety profile defined as incidence, severity and relationship of treatment-emergent adverse events


Secondary Outcome Measures :
  1. Patient Global Assessment [ Time Frame: 3 & 6 months ]
    Hair satisfaction scale

  2. Investigator Global Assessment [ Time Frame: 3 & 6 months ]
    Hair Satisfaction Scale

  3. Proportion of Patients with SALT50 [ Time Frame: 3 months & 6 months ]
  4. Proportion of Patients with SALT75 [ Time Frame: 3 months & 6 months ]
  5. Proportion of Patients with SALT90 [ Time Frame: 3 months & 6 months ]
  6. Proportion of Patients with SALT100 (Disease-free) [ Time Frame: 3 months & 6 months ]
  7. Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS) [ Time Frame: 3 months ]
  8. Change from Baseline on Dermatology Life Quality Index (DLQI) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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.
  3. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Any ongoing topical treatment for alopecia areata
  5. History of or currently active primary or secondary immunodeficiency.
  6. 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.
  7. Received other investigational products or therapy in the 60 days prior to study drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532958


Contacts
Contact: Paul Frohna, MD, PhD 858-205-5285 paul@bioniz.com

Sponsors and Collaborators
Bioniz Therapeutics

Responsible Party: Bioniz Therapeutics
ClinicalTrials.gov Identifier: NCT03532958     History of Changes
Other Study ID Numbers: BNZ1-CT-202
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical