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Hope for rare skin disease: new drug shows promise in trial

NCT ID NCT05856526

Disease control Sponsor: Boehringer Ingelheim 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a medicine called spesolimab for people with Netherton syndrome, a rare genetic skin condition causing severe redness and scaling. About 43 people aged 12 and older took part, receiving either the drug or a placebo. The goal was to see if spesolimab could reduce skin symptoms over 4 months, with all participants eventually receiving the drug. The trial was stopped early, but results may still offer insights for future treatments.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

43 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2025

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

12 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: * Male or female patients, aged 12 years and older (weight minimum is 35kg). * Confirmed diagnosis of Netherton syndrome (NS) (causative SPINK5 mutations) at baseline (Visit 2). * At least moderate severity of erythema at baseline (visit 2) (Ichthyosis Area Severity Index (IASI) score ≥ 16 and IASI-Erythema (E) score ≥8) and ≥ 3 on Investigator Global Assessment (IGA) score. * Signed and dated written informed consent and assent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission in the trial * Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the clinical trial protocol (CTP) as well as in the patient, parent(s) (or patient's legal guardian) information. Exclusion Criteria: * Patients who have used topical corticosteroids (medium to high, US class I-V), topical retinoids, topical calcineurin inhibitors or keratolytics within 1 week prior to randomisation * Patients who have used emollient on the area to be biopsied in the previous 24 hours * Patients who have used systemic retinoids, other systemic immunosuppressants, systemic corticosteroids or phototherapy within 4 weeks prior to randomisation * Patients who have used systemic antibiotics within 2 weeks prior to randomisation * Patients who have received live vaccines within 4 weeks prior to randomisation * Patients who have received investigational products, biologics or immunoglobulins within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation * Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold Upper Limit of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin * Patients who have any prior exposure to BI 655130 or another interleukin 36 receptor (IL-36R) inhibitor biologics * Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Netherton syndrome

As listed by the trial registrant

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

Netherton syndrome

Contacts and locations

Locations

  • ASMC-IPSMC-skin and Veneral Diseases

    Sofia, 1407, Bulgaria

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • Beijing Children's Hospital, Capital Medical University

    Beijing, 100045, China

  • Dermatology Hospital, Chinese Academy of Medical Sciences

    Nanjing, 210000, China

  • Erasmus MC Sophia Kinderziekenhuis

    Rotterdam, 3015 GD, Netherlands

  • HOP Saint-Louis

    Paris, 75010, France

  • Hospital Tunku Azizah

    Kuala Lumpur, 50300, Malaysia

  • Istituto Dermopatico Dell'Immacolata - IDI - IRCCS

    Roma, 00167, Italy

  • Juntendo University Urayasu Hospital

    Chiba, Urayasu, 279-0021, Japan

  • Klinikum der Universität München AÖR

    München, 80337, Germany

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mission Dermatology Center

    Rancho Santa Margarita, California, 92688, United States

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560, Japan

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Shanghai Skin Disease Hospital

    Shanghai, 200000, China

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Southern Medical University Dermatology Hospital

    Guangzhou, 510091, China

  • The Children's Hospital Zhejiang University School Of Medicine

    Hangzhou, 310000, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003, China

  • ULS de São José, E.P.E. - Hospital Sto. António Capuchos

    Lisbon, 1169-050, Portugal

  • University Children Hospital Zürich

    Zurich, 8032, Switzerland

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University

    Shanghai, 200092, China

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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