Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Drug: Placebo matching Spesolimab Formulation 1Drug: Placebo matching Spesolimab Formulation 2
- Registration Number
- NCT05819398
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Main endpoints for Part 2 will be supported by Part 1 results available at time of primary analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- 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.
- Total dT count of at least 1 at Baseline visit. Further inclusion criteria apply.
- 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.
Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I: Low dose group Spesolimab Formulation 1 - Part I: Low dose group Spesolimab Formulation 2 - Part I: Medium dose group Spesolimab Formulation 1 - Part I: Medium dose group Spesolimab Formulation 2 - Part I: High dose group Spesolimab Formulation 1 - Part I: High dose group Spesolimab Formulation 2 - Part I: Placebo group Placebo matching Spesolimab Formulation 1 - Part I: Placebo group Placebo matching Spesolimab Formulation 2 - Part II: Active (treatment) group Spesolimab Formulation 2 - Part II: Placebo group Placebo matching Spesolimab Formulation 2 -
- Primary Outcome Measures
Name Time Method Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8 At baseline and at week 8
- Secondary Outcome Measures
Name Time Method Part 1: Percent change from baseline in dT count at Week 16 (part 1) At baseline and at week 16 Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8 At baseline and at week 8 The IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).
A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.Part 1: Absolute change from baseline in IHS4 value at Week 16 At baseline and at week 16 Part 1: Occurrence of treatment emergent adverse events (TEAEs) up to 64 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (158)
Dokkyo Medical University Hospital
🇯🇵Tochigi, Shimotsuga-gun, Japan
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
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
University Hospital Bulovka
🇨🇿Prague, Czechia
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
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, 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
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
Univ. Hospital Kralovske Vinohrady
🇨🇿Praha, Czechia
The First Hospital of Jilin University
🇨🇳Changchun, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, China
West China Hospital
🇨🇳Chengdu, China
Southern Medical University Dermatology Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
HOP Pontchaillou
🇫🇷Rennes, France
Xinjiang Uygur Autonomous Region People's Hospital
🇨🇳Urumqi, China
Wuhan Union Hospital
🇨🇳Wuhan, China
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Bispebjerg og Frederiksberg Hospital
🇩🇰København NV, Denmark
Sjællands Universitetshospital
🇩🇰Roskilde, Denmark
HOP la Milétrie
🇫🇷Poitiers, France
Suomen Terveystalo oy Tampere
🇫🇮Tampere, Finland
HOP Privé Antony
🇫🇷Antony, France
HOP Edouard Herriot
🇫🇷Lyon, France
HOP Timone
🇫🇷Marseille, France
HOP l'Archet
🇫🇷Nice, France
HOP Saint-Louis
🇫🇷Paris, 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 "G. Papageorgiou"
🇬🇷Thessaloniki, Greece
Haemek Medical Center
🇮🇱Afula, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Rabin Medical Center Beilinson
🇮🇱Petach 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, Nakagami-gun, Japan
Kansai Medical University Hospital
🇯🇵Osaka, Hirakata, Japan
Shiga University of Medical Science Hospital
🇯🇵Shiga, Otsu, 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
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
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 Bahru, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Hospital Sultanah Nur Zahirah
🇲🇾Kuala Trengganu, 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 Estudios Clinicos SA de CV
🇲🇽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
🇵🇱Rzeszow, Poland
High-Med Specialist Clinic, Warsaw
🇵🇱Warsaw, Poland
National Medical Institute MSWiA
🇵🇱Warsaw, Poland
Provita Clinic
🇵🇱Warsaw, Poland
Royalderm
🇵🇱Warszawa, Poland
Centrum Zdrowia WroMedica
🇵🇱Wroclaw, Poland
National University Hospital-Singapore-42005
🇸🇬Singapore, Singapore
DOST sro - Sanatorium-Type Dermatovenereological Department
🇸🇰Svidnik, Slovakia
FN Trnava
🇸🇰Trnava, Slovakia
TASK Applied Science
🇿🇦Cape Town, South Africa
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
University Hospital Basel
🇨🇭Basel, Switzerland
University Hospital Bern/Inselspital Bern
🇨🇭Bern, Switzerland
Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie
🇨🇭Geneve, Switzerland
Chang Gung Memorial Hospital(Linkou)
🇨🇳TaoYuan, Taiwan
SBU Gulhane Training and Research Hospital
🇹🇷Ankara, Turkey
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi
🇹🇷Samsun, Turkey
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, Vietnam