Alopecia AreataPhase 2NCT03532958
Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata
A Phase 2 study testing BNZ-1 and Normal saline in people with Alopecia Areata and Alopecia Totalis, run by Equillium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- BNZ-1 and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata
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
- Being tested
- BNZ-1, Normal saline
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNZ-1Drug
PEGylated peptide inhibitor of IL-2, IL-9, and IL-15
Normal salineDrug
Dose volume consistent with weight-based dosing of BNZ-1
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline Receives: Drug: Normal saline |
| Low Dose BNZ-1 | Experimental | 0.5 mg/kg QW Receives: Drug: BNZ-1 |
| Moderate Dose BNZ-1 | Experimental | 2 mg/kg QW Receives: Drug: BNZ-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline using the Severity of Alopecia Tool (SALT) score
Measured: 3 months
Treatment-Emergent Adverse Events
Safety profile defined as incidence, severity and relationship of treatment-emergent adverse events
Measured: 3 months
Secondary outcomes (8)
Alopecia Areata Investigator Global Assessment (AA-IGA)
Hair Satisfaction Scale
Measured: 3 & 6 months
Patient Global Assessment
Hair satisfaction scale
Measured: 3 & 6 months
Proportion of Patients with SALT50
Measured: 3 months & 6 months
Proportion of Patients with SALT75
Measured: 3 months & 6 months
Proportion of Patients with SALT90
Measured: 3 months & 6 months
Proportion of Patients with SALT100 (Disease-free)
Measured: 3 months & 6 months
Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS)
Measured: 3 months
Change from Baseline on Dermatology Life Quality Index (DLQI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startOct 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Transfer of study sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equillium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532958
- Sponsor's protocol ID
- BNZ1-CT-204
- Status last verified
- Sep 2022
- First submitted
- 10 May 2018
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Intravenous BNZ-1 in Patients With Moderate to Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT03532958
- Acronym / sponsor ID
- BNZ1-CT-204
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transfer of study sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EquilliumIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal salineNormal saline |
| Low Dose BNZ-1 | Experimental | Drug: BNZ-10.5 mg/kg QW |
| Moderate Dose BNZ-1 | Experimental | Drug: BNZ-12 mg/kg QW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNZ-1PEGylated peptide inhibitor of IL-2, IL-9, and IL-15 | Drug | Low Dose BNZ-1, Moderate Dose BNZ-1 |
| Normal salineDose volume consistent with weight-based dosing of BNZ-1 | Drug | Placebo |
Primary outcome
Change from baseline using the Severity of Alopecia Tool (SALT) score
Time frame: 3 months
Treatment-Emergent Adverse Events
Time frame: 3 months
Safety profile defined as incidence, severity and relationship of treatment-emergent adverse events
8 secondary outcomes
Alopecia Areata Investigator Global Assessment (AA-IGA)
Time frame: 3 & 6 months
Patient Global Assessment
Time frame: 3 & 6 months
Proportion of Patients with SALT50
Time frame: 3 months & 6 months
Proportion of Patients with SALT75
Time frame: 3 months & 6 months
Proportion of Patients with SALT90
Time frame: 3 months & 6 months
Proportion of Patients with SALT100 (Disease-free)
Time frame: 3 months & 6 months
Change from Baseline on Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: 3 months
Change from Baseline on Dermatology Life Quality Index (DLQI)
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNZ-1 and Normal saline in people with Alopecia Areata and Alopecia Totalis, run by Equillium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline using the Severity of Alopecia Tool (SALT) score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.