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New hope for HS sufferers: Long-Term drug trial shows promise

NCT ID NCT06241573

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at the long-term safety and effectiveness of spesolimab for people with hidradenitis suppurativa (HS), a painful skin condition. Participants who completed a prior spesolimab study receive injections under the skin every 2 weeks for about 1.5 years. The goal is to see how well the drug is tolerated and if it helps control HS 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 2/3

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

Participants

39 people

The number who actually took part.

Started

May 2024

Finished

Apr 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

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: 1. 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. 2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration. 3. Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial. 4. 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. Exclusion Criteria: 1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. 2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials. 3. Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials. 4. Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. 5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection. 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 (HS)

Contacts and locations

Locations

  • ASMC-IPSMC-skin and Veneral Diseases

    Sofia, 1407, Bulgaria

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario, L3Y 5G8, Canada

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B7, Canada

  • HOP Privé Antony

    Antony, 92160, France

  • Hautmedizin Saar

    Merzig, 66663, Germany

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010, Australia

  • Hospital Alemán

    Capital Federal, C1118AAT, Argentina

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB, Argentina

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang-Pulau Pinang-21953

    Georgetown Pulau Pinang, 10990, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161, Lithuania

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Integrative Skin Science and Research-Sacramento-69402

    Sacramento, California, 95815, United States

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011, Japan

  • Medical Center "Kordis"

    Pleven, 5800, Bulgaria

  • National University Hospital-Singapore-42005

    Singapore, 119074, Singapore

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610, Japan

  • Non-Public Health Care Facility LABDERM

    Ossy, 42624, Poland

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502, Japan

  • Provita Clinic

    Warsaw, 02-647, Poland

  • Royalderm

    Warsaw, 02-962, Poland

  • STAT Research

    CABA, C1023AAB, Argentina

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Sunway Medical Centre

    Selangor Darul Ehsan, 47500, Malaysia

  • The University of Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8655, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • Vilnius University Hospital, Santariskiu

    Vilnius, 08411, Lithuania

More trials for these conditions

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