Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Randomised, Double-blind, Placebo-controlled, Phase IIb/Phase III Study to Evaluate the Efficacy and Safety of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa. Lunsayil 1.
2 other identifiers
interventional
209
34 countries
161
Brief Summary
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedResults Posted
Study results publicly available
November 5, 2025
CompletedNovember 5, 2025
October 1, 2025
1.3 years
April 6, 2023
July 31, 2025
October 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8
Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline. Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
Secondary Outcomes (4)
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8
The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16
The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.
Study Arms (4)
Spesolimab low dose group
EXPERIMENTALPatients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
Spesolimab medium dose group
EXPERIMENTALPatients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Spesolimab high dose group
EXPERIMENTALPatients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Placebo
PLACEBO COMPARATORPatients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Interventions
Weekly dose of spesolimab via i.v. for 4 weeks.
Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.
Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.
Eligibility Criteria
You may qualify if:
- Of full age of consent at screening.
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
- Moderate to severe HS.
- HS lesions in at least 2 distinct anatomic areas.
- Biologic naive or Tumor Necrosis Factor inhibitor (TNFi)-exposed for HS.
- For biologic naïve, inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year prior to the Baseline visit, as per investigator discretion. All participants must have previous exposure to antibiotics for HS.
- Total AN count of greater than or equal to 5.
You may not qualify if:
- Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Prior exposure to any immunosuppressive/immunomodulatory biologic other than TNFi for HS.
- Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
- Treated with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
- Participants with a transplanted organ (with exception of a corneal transplant \>12 weeks prior to screening) or who has ever received stem cell therapy (e.g., Remestemcel-L).
- Participants with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (162)
First OC Dermatology
Fountain Valley, California, 92708, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, 95815, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Ziaderm Research
North Miami Beach, Florida, 33162, United States
ForCare Clinical Research, Inc.
Tampa, Florida, 33613, United States
Olympian Clinical Research-Tampa-69560
Tampa, Florida, 33615, United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, 46250, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, 48326, United States
Skin Specialists, P.C.
Omaha, Nebraska, 68144, United States
AXIS Clinicals
Fargo, North Dakota, 58103, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Palmetto Clinical Trial Services
Greenville, South Carolina, 29615, United States
Center for Clinical Studies-Houston-58806
Houston, Texas, 77004, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
STAT Research
CABA, C1023AAB, Argentina
Hospital Italiano de Buenos Aires
CABA, C1056AB, Argentina
Hospital Alemán
Capital Federal, C1118AAT, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, 7600, Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, 2000, Argentina
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, 4000, Argentina
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
AKH - Medical University of Vienna
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Medical Center "Kordis"
Pleven, 5800, Bulgaria
ASMC-IPSMC-skin and Veneral Diseases
Sofia, 1407, Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, 1431, Bulgaria
DCC "Fokus-5-LZIP" OOD
Sofia, 1463, Bulgaria
Medical Military Academy MHAT Sofia
Sofia, 1606, Bulgaria
MHAT Prof Stoyan Kirkovich AD
Stara Zagora, 6000, Bulgaria
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4B 1L1, Canada
Centro Internacional de Estudios Clínicos (CIEC)
Comuna de Recoleta, 8420383, Chile
Clínica Dermacross S.A.
Vitacura, 7640881, Chile
Peking University First Hospital
Beijing, 100034, China
The First Hospital of Jilin University
Changchun, 130021, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Southern Medical University Dermatology Hospital
Guangzhou, 510091, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Shanghai Skin Disease Hospital
Shanghai, 200000, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, 830001, China
Wuhan Union Hospital
Wuhan, 430022, China
University Hospital Ostrava
Ostrava, 708 00, Czechia
Fakultni Nemocnice Plzen
Plzen-Bory, 30100, Czechia
Univ. Hospital Kralovske Vinohrady
Prague, 100 34, Czechia
University Hospital Bulovka
Prague, 18081, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Bispebjerg og Frederiksberg Hospital
København NV, 2400, Denmark
Sjællands Universitetshospital
Roskilde, 4000, Denmark
Suomen Terveystalo oy Tampere
Tampere, 33100, Finland
HOP Privé Antony
Antony, 92160, France
HOP Edouard Herriot
Lyon, 69437, France
HOP Timone
Marseille, 13385, France
HOP l'Archet
Nice, 06200, France
HOP Saint-Louis
Paris, 75010, France
HOP la Milétrie
Poitiers, 86000, France
HOP Pontchaillou
Rennes, 35033, France
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Charite Universitätsmedizin Berlin KöR
Berlin, 10117, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, 44791, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075, Germany
Hautmedizin Saar
Merzig, 66663, Germany
Klinikum Oldenburg AöR
Oldenburg, 26133, Germany
University General Hospital Attikon
Athens, 124 62, Greece
Attikon University Hospital
Athens, 12462, Greece
Andreas Syggros Hospital of Cutaneous & Venereal Diseases
Athens, 16121, Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 54643, Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, 56403, Greece
Haemek Medical Center
Afula, 1834111, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Rabin Medical Center Beilinson
Petah Tikva, 49100, Israel
Sheba MC
Ramat Gan, 52621, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Pol. Universitario Tor Vergata
Roma, 00133, Italy
Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
Roma, 00167, Italy
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510, Japan
Nagoya City University Hospital
Aichi, Nagoya, 467-8602, Japan
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502, Japan
Meiwa Hospital
Hyogo, Nishinomiya, 663-8186, Japan
University of Tsukuba Hospital
Ibaraki, Tsukuba, 305-8576, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama, 701-1192, Japan
University of the Ryukyus Hospital
Okinawa, Ginowan, 901-2725, Japan
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191, Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, 520-2192, Japan
Dokkyo Medical University Hospital
Tochigi, Shimotsuga-gun, 321-0293, Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023, Japan
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161, Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, 08411, Lithuania
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990, Malaysia
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bharu, 15586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, 20400, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, 47500, Malaysia
Derma Norte del Bajio S.C.
Aguascalientes, 20127, Mexico
Grupo Clinico CATEI S.C.
Guadalajara, 44638, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Eukarya Pharmasite
Monterrey, 64718, Mexico
Arke SMO S.A. de C.V.
Veracruz, 91910, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
Waikato Hospital
Hamilton, 3204, New Zealand
Southern Philippines Medical Center -Davao-62091
Davao City, 8000, Philippines
Center for Skin Research, Testing and Product Development
Makati City, 1200, Philippines
Philippine General Hospital
Manila, Philippines, 1000, Philippines
East Avenue Medical Center
Quezon City, 1100, Philippines
Non-Public Health Care Facility LABDERM
Ossy, 42624, Poland
NSZOZ Termedica Clinical Research Center
Poznan, 60-681, Poland
Frederic Chopin University Hospital No. 1 in Rzeszow
Rzeszów, 35055, Poland
High-Med Specialist Clinic, Warsaw
Warsaw, 01-817, Poland
National Medical Institute MSWiA
Warsaw, 02-507, Poland
Provita Clinic
Warsaw, 02-647, Poland
Royalderm
Warsaw, 02-962, Poland
Centrum Zdrowia WroMedica
Wroclaw, 51-685, Poland
National University Hospital-Singapore-42005
Singapore, 119074, Singapore
DOST sro - Sanatorium-Type Dermatovenereological Department
Svidník, 089 01, Slovakia
FN Trnava
Trnava, 91702, Slovakia
TASK Applied Science
Cape Town, 7530, South Africa
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Universitario Reina Sofía-Córdoba-40500
Córdoba, 14004, Spain
Hospital Universitario San Cecilio
Granada, 18012, Spain
Hospital General de Granollers
Granollers, 08402, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital de Manises
Manises, 46940, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Universitätsspital Basel
Basel, 4055, Switzerland
University Hospital Bern/Inselspital Bern
Bern, 3010, Switzerland
Hôpitaux Universitaires Genève (HUG)
Geneva, 1205, Switzerland
Chang Gung Memorial Hospital Linkou
Taoyuan District, 333, Taiwan
SBU Gulhane Training and Research Hospital
Ankara, 06011, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 7070, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55270, Turkey (Türkiye)
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
St George's Hospital-London-26733
London, SW17 0QT, United Kingdom
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City, 70000, Vietnam
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The Part 2 was not initiated due to discontinuation of this trial according to protocol. The interim analysis in Part 1 was done after all patients reached Week 16 milestone, and following the analysis, the decision to discontinue was taken.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 19, 2023
Study Start
April 17, 2023
Primary Completion
August 1, 2024
Study Completion
March 31, 2025
Last Updated
November 5, 2025
Results First Posted
November 5, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
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