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TerminatedPhase 2/3

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

Key facts

Who runs it
Boehringer Ingelheim
Where
Fountain Valley, Los Angeles, Sacramento, and Thousand Oaks, United StatesSee the 4 sitesAlso in 21 other countries, 88 sites
Trial code
Status
Terminated
Phase
Phase 2/3
People taking part
39 people enrolled
Started
8 May 2024
Ended
11 Apr 2025
Type of study
Interventional, 3 groups
Treatments tested
  • Spesolimab
  • Placebo
Record updated
17 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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
  • Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration
  • 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
  • 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

Who cannot take part

  • 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
  • Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials
  • Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial
  • 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
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Where in United States

Also in 21 other countries, 88 sites

  • First OC DermatologyFountain Valley, United StatesNo longer taking part
  • Dermatology Research AssociatesLos Angeles, United StatesNo longer taking part
  • Integrative Skin Science and Research-Sacramento-69402Sacramento, United StatesNo longer taking part
  • Clinical Trials Research InstituteThousand Oaks, United StatesNo longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Spesolimab low doseTreatment being tested

    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.

    Treatment: Spesolimab and Placebo

  • Spesolimab high doseTreatment being tested

    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.

    Treatment: Spesolimab

  • Spesolimab high dose with prior placeboTreatment being tested

    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.

    Treatment: Spesolimab

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
Record updated
17 June 2026