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

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: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: Spesolimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • CABA, Argentina, C1023AAB
    • STAT Research
  • Capital Federal, Argentina, C1118AAT
    • Hospital Aleman
• 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
    • Hôpital 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

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spesolimab low dose; Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Drug: Spesolimab; Administered every 2 weeks with a subcutaneous injection.; Drug: Placebo; Administered every 2 weeks with a subcutaneous injection.
Experimental: Spesolimab high dose; Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Drug: Spesolimab; Administered every 2 weeks with a subcutaneous injection.
Experimental: Spesolimab high dose with prior placebo; Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Drug: Spesolimab; Administered every 2 weeks with a subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period	The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. TEAEs were defined as all adverse events occurring between start of treatment in the extension trial and the end of its residual effect period. Adverse events that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial were also considered as 'treatment-emergent'.	From first drug administration, up to 16 weeks after last administration, up to 39 weeks.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

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): June 17, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; spesolimab
• 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).

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

• 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