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New pill could tame blistering skin disease without high steroid doses

NCT ID NCT06696716

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This phase 3 study tests an experimental drug called tirabrutinib for people with pemphigus, a rare autoimmune disease that causes painful blisters on skin and mucous membranes. The trial enrolls 34 adults whose disease is not well controlled by steroids. Participants receive either tirabrutinib or a placebo pill daily, plus a low dose of steroids. The main goal is to see if the drug helps achieve and maintain remission (no or minimal blisters) for at least 8 weeks while keeping steroid use low.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tirabrutinib (a drug taken as a pill that targets a protein involved in immune attacks)
What this could lead to
If successful, this could offer a new treatment option for people with pemphigus that doesn't respond well to steroids, potentially helping control blisters with less steroid use.
What could go wrong
This is a small early-phase 3 trial with only 34 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects like infection or allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with a diagnosis of pemphigus * Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent Exclusion Criteria: * Patients with an active infection * Patients with malignancy * Patients with past history of serious allergy or anaphylaxis

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Conditions

The condition(s) this trial relates to.

pemphigus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pemphigus Steroid-resistant pemphigus

Contacts and locations

Locations

  • Ehime University Hospital

    Ehime, Japan

  • Fukushima Medical University Hospital

    Fukushima, Japan

  • Gunma University Hospital

    Gunma, Japan

  • Hokkaido University Hospital

    Hokkaido, Japan

  • Ichinomiya Municipal Hospital

    Aichi, Japan

  • Jichi Medical University Hospital

    Tochigi, Japan

  • Kagoshima University Hospital

    Kagoshima, Japan

  • Kawasaki Medical School Hospital

    Okayama, Japan

  • Keio University Hospital

    Tokyo, Japan

  • Kindai university hospital

    Osaka, Japan

  • Kumamoto University Hospital

    Kumamoto, Japan

  • Kurume University Hospital

    Fukuoka, Japan

  • Nagoya City University Hospital

    Aichi, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Japan

  • Saitama Medical Center

    Saitama, Japan

  • Shiga University of Medical Science Hospital

    Shiga, Japan

  • St.Marianna University School of Medicine Hospital

    Kanagawa, Japan

  • Tokai University Hospital

    Kanagawa, Japan

  • Tokyo Medical and Dental University Hospital

    Tokyo, Japan

  • Tokyo Women'ｓ Medical University Hospital

    Tokyo, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Japan

  • University of the Ryukyus Hospital

    Okinawa, Japan

  • Yamagata University Hospital

    Yamagata, Japan

  • Yokohama City University Hospital

    Kanagawa, Japan

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