A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

January 29, 2026 updated by: Boehringer Ingelheim

Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100).

The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.

Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • CABA, Argentina, C1023AAB
        • Stat Research
      • Capital Federal, Argentina, C1118AAT
        • Hospital Alemán
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Medical Center "Kordis"
      • Sofia, Bulgaria, 1407
        • ASMC-IPSMC-skin and Veneral Diseases
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Simcoderm Medical and Surgical Dermatology Centre
      • Guelph, Ontario, Canada, N1L 0B7
        • Guelph Dermatology Research
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Dr. S. K. Siddha Medicine Professional Corporation
  • France
      • Antony, France, 92160
        • HOP Privé Antony
      • Lyon, France, 69437
        • HOP Edouard Herriot
  • Germany
      • Bad Bentheim, Germany, 48455
        • Fachklinik Bad Bentheim
      • Merzig, Germany, 66663
        • Hautmedizin Saar
  • Japan
      • Fukuoka, Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Gifu, Ogaki, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8655
        • The University of Tokyo Hospital
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Tokyo, Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
      • Vilnius, Lithuania, 08411
        • Vilnius University Hospital, Santariskiu
  • Malaysia
      • Georgetown Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang-Pulau Pinang-21953
      • Johor Bahru, Malaysia, 81100
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
      • Selangor Darul Ehsan, Malaysia, 47500
        • Sunway Medical Centre
  • Poland
      • Ossy, Poland, 42624
        • Non-Public Health Care Facility LABDERM
      • Warsaw, Poland, 02-647
        • Provita Clinic
      • Warsaw, Poland, 02-962
        • Royalderm
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital-Singapore-42005
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
  • Spain
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research-Sacramento-69402
      • Thousand Oaks, California, United States, 91320
        • Clinical Trials Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients treated in Part I of parent trial 1368-0098 (NCT05819398)
Drug: Spesolimab
Spesolimab
Experimental: Patients treated in Part II of parent trial 1368-0098 (NCT05819398)
Drug: Spesolimab
Spesolimab
Experimental: Patients treated in parent trial 1368-0100
Drug: Spesolimab
Spesolimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of treatment emergent adverse events (TEAE)
Time Frame: up to 92 weeks
up to 92 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Actual)

April 11, 2025

Study Completion (Actual)

April 11, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1368-0130
  • 2023-508377-82-00 (Registry Identifier: CTIS (EU))
  • U1111-1300-2310 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents upon signing of a 'Document Sharing Agreement'. For study data 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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