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Bullous PemphigoidPhase 2NCT03286582

A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid

A Phase 2 study testing AC-203 1% Topical Ointment and Clobetasol 0.05% Topical Ointment in people with Bullous Pemphigoid, run by TWi Biotechnology, Inc. at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Bullous pemphigoid (BP) is a chronic, inflammatory, subepidermal, autoimmune blistering disease which mainly develops in the elderly, with onset usually in the late 70s and a substantial increase in incidence in people older than 80 years. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Bullous Pemphigoid
What is being tested?
AC-203 1% Topical Ointment and Clobetasol 0.05% Topical Ointment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTaiwan
Study dates
5 Sep 2017to 22 Jan 2019
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 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20 to 90 years old, inclusive, at enrollment.
  • Diagnosis of bullous pemphigoid confirmed by histopathology and one of following assessments:
  • Direct immunofluorescence (DIF)
  • Indirect immunofluorescence (IIF)
  • ELISA test (ELISA detection of immunoglobulin G (IgG) anti-BP180 autoantibodies in serum more than 9 U/mL).
  • Localized or limited BP with the occurrence of <10 new blisters per day in the week prior to enrollment.
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  • Is male, or is female and meets all the following criteria:
  • Not breastfeeding
  • If of childbearing potential (defined as non-post hysterectomy or non-post-menopausal [≥50 years of age and amenorrheic for at least 1 year]), must have a negative pregnancy test result (human chorionic gonadotropin, beta subunit [bhCG]) at Visit 1, and must practice and be willing to continue to practice appropriate birth control (abstinence, double barrier methods, hormonal contraceptives, intrauterine device, or tubal ligation) during the entire duration of the study
  • Is able to understand and sign the Informed Consent Form (ICF), communicate with the investigator, and understand and comply with protocol requirements.

Who cannot join

  • Diagnosis of pemphigus, dermatitis, eczema, psoriasis, or other skin condition which in the opinion of the investigator may confound diagnosis, treatment, or evaluation of bullous pemphigoid.
  • Use of oral steroids in the 2 weeks prior to enrollment at a dose greater than prednisolone equivalent dose (PED) of 10 mg/day.
  • Use of topical steroids for more than 3 consecutive days in the 2 weeks prior to enrollment.
  • Use of non-steroid immunosuppressants including but not limited to azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, tacrolimus, or cyclosporine in the 2 weeks prior to enrollment.
  • Use of systemic antibiotics in the 2 weeks prior to enrollment.
  • Use of oral dapsone in the 2 weeks prior to enrollment.
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  • Treatment with intravenous immunoglobulin (IVIG) in the 8 weeks prior to enrollment.
  • Any prior use of approved or investigational biologic anti-inflammatory therapy within 6 months prior to enrollment, including but not limited to: anakinra, rilonacept, canakinumab, etanercept, adalimumab, infliximab, rituximab, certolizumab, golimumab, tocilizumab, bertilimumab, or abatacept.
  • Presence of active systemic infections.
  • Any clinically significant medical condition or laboratory value that could potentially affect study participation and/or personal well-being, as judged by the investigator.
  • History of allergy or hypersensitivity to any component of study medication or clobetasol.
  • Has participated in a clinical study within 30 days prior to enrollment.
  • Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site.
  • Is employed by the sponsor (i.e., is an employee, temporary contract worker, or designee responsible for the conduct of the study).

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Randomized, Open-Label, Controlled Trial of Topical AC-203 in Subjects With Bullous Pemphigoid

Bullous pemphigoid (BP) is a chronic, inflammatory, subepidermal, autoimmune blistering disease which mainly develops in the elderly, with onset usually in the late 70s and a substantial increase in incidence in people older than 80 years. If untreated, it can persist for months or years, with periods of spontaneous remissions and exacerbations. It has been found that blisters and sera of BP patients contain abnormally high levels of pro-inflammatory cytokines such as interleukin-6 (IL-6) and IL-8. Recently, it also has been demonstrated that NLRP3 (NACHT, LRR and PYD domains-containing protein 3) inflammasome components (the NLRP3-caspase-1-IL-18 axis) were significantly up-regulated in peripheral blood mononuclear cells from BP patients and positively correlated with disease activity. AC-203 is a topical formulation of an oral modulator of inflammasome and IL-1beta pathways. In vitro studies have demonstrated that AC-203 significantly reduced secretion of IL-6 and moderately reduced IL-8 secretion in HaCaT cells treated with specific anti-BP180 IgG. This study is designed to test the safety, tolerability, efficacy, and pharmacokinetics of AC-203 ointment (vs. a topical steroid comparator representing standard of care) ointment in subjects with BP.

Being tested
AC-203 1% Topical Ointment, Clobetasol 0.05% Topical Ointment
Medical subject headings
Pemphigoid, Bullous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC-203 1% Topical OintmentDrug

    AC-203 1% ointment BID (twice daily)

  • Clobetasol 0.05% Topical OintmentDrug

    Clobetasol 0.05% Topical Ointment BID

Study groups in NCT03286582
Study groupRoleWhat they receive
AC-203ExperimentalNot described
Receives: Drug: AC-203 1% Topical Ointment
ClobetasolActive comparatorNot described
Receives: Drug: Clobetasol 0.05% Topical Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events during the treatment period

    Measured: 10 Weeks

Secondary outcomes (8)

  1. Proportion achieving disease control (no new blisters within prior week)

    Measured: 2, 4, 5, 6, 8, 10 Weeks

  2. New blister count

    Measured: 2, 4, 5, 6, 8, 10 Weeks

  3. Time to disease control

    Measured: 2, 4, 5, 6, 8, 10 Weeks

  4. Proportion of subjects who require rescue therapy prior to Week 6

    Measured: 2, 4, 5, 6 Weeks

  5. BPDAI (BP Disease Area Index) score

    Measured: 2, 4, 5, 6, 8, 10 Weeks

  6. Pruritus VAS (Visual Analogue Scale) score change from baseline

    Measured: 2, 4, 5, 6, 8, 10 Weeks

  7. DLQI (Dermatology Life Quality Index) score change from baseline

    Measured: 6, 10 Weeks

  8. Inflammation marker

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2017
  2. Study start5 Sep 2017
  3. Primary completion25 Dec 2018
  4. Study completion22 Jan 2019

Why it stopped: Terminated with partial enrollment completed

Resources

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
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03286582
Sponsor's protocol ID
AC-203-BP-001
Status last verified
Sep 2019
First submitted
14 Sep 2017
Last updated
19 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cho YT, Lee CH, Lee JY, Chu CY. Targeting antibody-mediated complement-independent mechanism in bullous pemphigoid with diacerein. J Dermatol Sci. 2024 Apr;114(1):44-51. doi: 10.1016/j.jdermsci.2024.03.001. Epub 2024 Mar 6.

    PubMed 38508975

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC-203 1% Topical Ointment and Clobetasol 0.05% Topical Ointment in people with Bullous Pemphigoid, run by TWi Biotechnology, Inc. at 1 site in Taiwan.

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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 stopped early (reason given: Terminated with partial enrollment completed). Results are not available in the source record.

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?

Incidence of adverse events during the treatment period (time frame: 10 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03286582, which also lists 1 linked publication.

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 19 Sep 2019.

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