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New shot could help patients with severe blistering skin disease ditch steroids

NCT ID NCT07210554

Disease control Sponsor: Chengdu Kangnuoxing Biopharma,Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an injection called stapokibart for people with moderate to severe bullous pemphigoid, a painful blistering skin condition. The goal is to see if it can help patients stop taking steroids and keep the disease under control for 36 weeks. About 200 adults aged 18 to 90 will participate, receiving either the drug or a placebo.

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 200 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

May 2028

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

18 to 90 years

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: * Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF). * Aged between 18 and 90 years, inclusive, regardless of gender. * Confirmed diagnosis of bullous pemphigoid prior to randomization. * Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization. * Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization. * Karnofsky Performance Status score ≥50% at the screening visit. Exclusion Criteria: * Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases. * Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid. * Insufficient washout period for prior treatments. * Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.

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Conditions

The condition(s) this trial relates to.

bullous pemphigoid

As listed by the trial registrant

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

Bullous pemphigoid (BP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.