Hidradenitis Suppurativa (HS)Phase 2/3NCT06241573
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
A Phase 2/3 study testing Spesolimab in people with Hidradenitis Suppurativa (HS), run by Boehringer Ingelheim at 36 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Spesolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 36 sitesin 14 countries
- Study dates
- 8 May 2024to 11 Apr 2025
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- 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.
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
Japan5 sites
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Malaysia5 sites
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990
Hospital Sultan Ismail
Johor Bahru, 81100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Sarawak General Hospital
Kuching, 93586
Sunway Medical Centre
Selangor Darul Ehsan, 47500
United States4 sites
First OC Dermatology
Fountain Valley, California, 92708
Dermatology Research Associates
Los Angeles, California, 90045
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, 95815
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Argentina3 sites
STAT Research
CABA, C1023AAB
Hospital Italiano de Buenos Aires
CABA, C1199ABB
Hospital Alemán
Capital Federal, C1118AAT
Canada3 sites
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
Poland3 sites
Non-Public Health Care Facility LABDERM
Ossy, 42624
Provita Clinic
Warsaw, 02-647
Royalderm
Warsaw, 02-962
Australia2 sites
Alfred Hospital
Melbourne, Victoria, 3004
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Bulgaria2 sites
Medical Center "Kordis"
Pleven, 5800
ASMC-IPSMC-skin and Veneral Diseases
Sofia, 1407
France2 sites
HOP Privé Antony
Antony, 92160
Hôpital Edouard Herriot
Lyon, 69437
Germany2 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Hautmedizin Saar
Merzig, 66663
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161
Vilnius University Hospital, Santariskiu
Vilnius, 08411
Singapore1 site
National University Hospital-Singapore-42005
Singapore, 119074
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Spesolimab, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Administered every 2 weeks with a subcutaneous injection.
PlaceboDrug
Administered every 2 weeks with a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab low dose | Experimental | 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. Receives: Drug: Spesolimab; Drug: Placebo |
| Spesolimab high dose | Experimental | 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. Receives: Drug: Spesolimab |
| Spesolimab high dose with prior placebo | Experimental | 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. Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: From first drug administration, up to 16 weeks after last administration, up to 39 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start8 May 2024
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241573
- Sponsor's protocol ID
- 1368-0130
- Other IDs
- 2023-508377-82-00, U1111-1300-2310, 2023
- Status last verified
- May 2026
- First submitted
- 29 Jan 2024
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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