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New hope for HS patients: Long-Term drug shows promise

NCT ID NCT04876391

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the long-term safety and effectiveness of the drug spesolimab for adults with hidradenitis suppurativa (HS), a painful skin condition. Participants who had already completed a previous spesolimab trial received injections every two weeks for two years. The goal was to see if the drug remains safe and helps control HS symptoms over time.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Started

Aug 2021

Finished

Apr 2024

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 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 who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation * Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Woman 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 patient information and consent form. Exclusion Criteria: * Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial * Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof * Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix * Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial * History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients * Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator * Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

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

Hidradenitis suppurativa

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • CLI Reims Bezannes

    Bezannes, 51430, France

  • Cityclinic Medical and Psychological Clinic Matusiak Partnership

    Wroclaw, 50-566, Poland

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713

    Indianapolis, Indiana, 46250, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario, L3Y 5G8, Canada

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD, Netherlands

  • HOP Edouard Herriot

    Lyon, 69437, France

  • HOP Larrey

    Toulouse, 31059, France

  • Haukeland Universitetssykehus

    Bergen, N-5021, Norway

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010, Australia

  • Hospital La Princesa

    Madrid, 28006, Spain

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Non-Public Health Care Facility LABDERM

    Ossy, 42624, Poland

  • Nordlandssykehuset HF, Bodø

    Bodø, N-8092, Norway

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372, Norway

  • Ospedali Riuniti di Ancona

    Ancona, 60123, Italy

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Städtisches Klinikum Dessau

    Dessau, 06847, Germany

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

  • University Hospital Ostrava

    Ostrava, 708 52, Czechia

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

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