Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
NCT ID: NCT05819398
Last Updated: 2025-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
209 participants
INTERVENTIONAL
2023-04-17
2025-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Spesolimab low dose group
Patients 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 i.v.
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab s.c.
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.
Spesolimab medium dose group
Patients 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 i.v.
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab s.c.
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.
Spesolimab high dose group
Patients 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).
Spesolimab i.v.
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab s.c.
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.
Placebo
Patients 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).
Spesolimab s.c.
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.
Placebo matching Spesolimab i.v.
Weekly dose of placebo via i.v. for 4 weeks.
Placebo matching Spesolimab s.c.
Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.
Interventions
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Spesolimab i.v.
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab s.c.
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.
Placebo matching Spesolimab i.v.
Weekly dose of placebo via i.v. for 4 weeks.
Placebo matching Spesolimab s.c.
Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Moderate to severe HS.
4. HS lesions in at least 2 distinct anatomic areas.
5. Biologic naive or Tumor Necrosis Factor inhibitor (TNFi)-exposed for HS.
6. 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.
7. Total AN count of greater than or equal to 5.
Exclusion Criteria
2. Prior exposure to any immunosuppressive/immunomodulatory biologic other than TNFi for HS.
3. Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
4. 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.
5. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
6. Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
7. 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).
8. 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Suomen Terveystalo oy Tampere
Tampere, , Finland
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
Ziaderm Research
North Miami Beach, Florida, United States
ForCare Clinical Research, Inc.
Tampa, Florida, United States
Olympian Clinical Research-Tampa-69560
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, United States
Skin Specialists, P.C.
Omaha, Nebraska, United States
AXIS Clinicals
Fargo, North Dakota, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Clinical Trial Services
Greenville, South Carolina, United States
Center for Clinical Studies-Houston-58806
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
STAT Research
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Hospital Alemán
Capital Federal, , Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, , Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, , Argentina
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, , Argentina
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
AKH - Medical University of Vienna
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Medical Center "Kordis"
Pleven, , Bulgaria
ASMC-IPSMC-skin and Veneral Diseases
Sofia, , Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, , Bulgaria
DCC "Fokus-5-LZIP" OOD
Sofia, , Bulgaria
Medical Military Academy MHAT Sofia
Sofia, , Bulgaria
MHAT Prof Stoyan Kirkovich AD
Stara Zagora, , Bulgaria
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Centro Internacional de Estudios Clínicos (CIEC)
Comuna de Recoleta, , Chile
Clínica Dermacross S.A.
Vitacura, , Chile
Peking University First Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Southern Medical University Dermatology Hospital
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, , China
Wuhan Union Hospital
Wuhan, , China
University Hospital Ostrava
Ostrava, , Czechia
Fakultni Nemocnice Plzen
Plzen-Bory, , Czechia
Univ. Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Bulovka
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Bispebjerg og Frederiksberg Hospital
København NV, , Denmark
Sjællands Universitetshospital
Roskilde, , Denmark
HOP Privé Antony
Antony, , France
HOP Edouard Herriot
Lyon, , France
HOP Timone
Marseille, , France
HOP l'Archet
Nice, , France
HOP Saint-Louis
Paris, , France
HOP la Milétrie
Poitiers, , France
HOP Pontchaillou
Rennes, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Katholisches Klinikum Bochum gGmbH
Bochum, , Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, , Germany
Hautmedizin Saar
Merzig, , Germany
Klinikum Oldenburg AöR
Oldenburg, , Germany
University General Hospital Attikon
Athens, , Greece
Attikon University Hospital
Athens, , Greece
Andreas Syggros Hospital of Cutaneous & Venereal Diseases
Athens, , Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, , Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, , Greece
Haemek Medical Center
Afula, , Israel
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Sheba MC
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
Roma, , Italy
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, , Japan
Nagoya City University Hospital
Aichi, Nagoya, , Japan
Fujita Health University Hospital
Aichi, Toyoake, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Kurume University Hospital
Fukuoka, Kurume, , Japan
Ogaki Municipal Hospital
Gifu, Ogaki, , Japan
Meiwa Hospital
Hyogo, Nishinomiya, , Japan
University of Tsukuba Hospital
Ibaraki, Tsukuba, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama, , Japan
University of the Ryukyus Hospital
Okinawa, Ginowan, , Japan
Kansai Medical University Hospital
Osaka, Hirakata, , Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, , Japan
Dokkyo Medical University Hospital
Tochigi, Shimotsuga-gun, , Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, , Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, , Lithuania
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, , Malaysia
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Hospital Sultan Ismail
Johor Bahru, , Malaysia
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bharu, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, , Malaysia
Derma Norte del Bajio S.C.
Aguascalientes, , Mexico
Grupo Clinico CATEI S.C.
Guadalajara, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
Eukarya Pharmasite
Monterrey, , Mexico
Arke SMO S.A. de C.V.
Veracruz, , Mexico
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Waikato Hospital
Hamilton, , New Zealand
Southern Philippines Medical Center -Davao-62091
Davao City, , Philippines
Center for Skin Research, Testing and Product Development
Makati City, , Philippines
Philippine General Hospital
Manila, Philippines, , Philippines
East Avenue Medical Center
Quezon City, , Philippines
Non-Public Health Care Facility LABDERM
Ossy, , Poland
NSZOZ Termedica Clinical Research Center
Poznan, , Poland
Frederic Chopin University Hospital No. 1 in Rzeszow
Rzeszów, , Poland
High-Med Specialist Clinic, Warsaw
Warsaw, , Poland
National Medical Institute MSWiA
Warsaw, , Poland
Provita Clinic
Warsaw, , Poland
Royalderm
Warsaw, , Poland
Centrum Zdrowia WroMedica
Wroclaw, , Poland
National University Hospital-Singapore-42005
Singapore, , Singapore
DOST sro - Sanatorium-Type Dermatovenereological Department
Svidník, , Slovakia
FN Trnava
Trnava, , Slovakia
TASK Applied Science
Cape Town, , South Africa
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofía-Córdoba-40500
Córdoba, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital General de Granollers
Granollers, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital de Manises
Manises, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Universitätsspital Basel
Basel, , Switzerland
University Hospital Bern/Inselspital Bern
Bern, , Switzerland
Hôpitaux Universitaires Genève (HUG)
Geneva, , Switzerland
Chang Gung Memorial Hospital Linkou
Taoyuan District, , Taiwan
SBU Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, , Turkey (Türkiye)
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
St George's Hospital-London-26733
London, , United Kingdom
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City, , Vietnam
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2022-501074-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
1368-0098
Identifier Type: -
Identifier Source: org_study_id
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