Phase
Condition
Scalp Disorders
Rosacea
Acne Inversa
Treatment
Spesolimab Formulation 1
Placebo matching Spesolimab Formulation 2
Spesolimab Formulation 2
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Of full age of consent at screening.
Signed and dated written informed consent in accordance with International Councilon Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior toadmission 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 oralantibiotics for treatment of HS in the last 1 year prior to the Baseline visit, asper investigator discretion. All participants must have previous exposure toantibiotics 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.
Exclusion
Exclusion Criteria:
Participants who must or wish to continue the intake of restricted medications orany drug considered likely to interfere with the safe conduct of the trial.
Prior exposure to any immunosuppressive/immunomodulatory biologic other than TNFifor HS.
Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
Treated with any investigational device or investigational drug of chemical orbiologic nature within a minimum of 30 days or 5 half-lives of the drug, whicheveris longer.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Participants with history of allergy/hypersensitivity to the systemicallyadministered trial medication agent or its excipients.
Participants with a transplanted organ (with exception of a corneal transplant >12weeks 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 ofmalignancy within 5 years prior to the screening visit, except appropriately treatedbasal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situcarcinoma of uterine cervix.
Further exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Hospital Italiano de Buenos Aires
Caba, C1056AB
ArgentinaSite Not Available
STAT Research
Caba, C1023AAB
ArgentinaSite Not Available
Hospital Alemán
Capital Federal, C1118AAT
ArgentinaSite Not Available
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, 7600
ArgentinaSite Not Available
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, 7600
ArgentinaActive - Recruiting
Instituto de Especialidades de la Salud Rosario
Rosario, 2000
ArgentinaSite Not Available
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, 4000
ArgentinaSite Not Available
Holdsworth House Medical Practice
Sydney, New South Wales 2010
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
AKH - Medical University of Vienna
Vienna, 1090
AustriaSite Not Available
Hospital Hietzing
Wien, 1130
AustriaSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liège
Liège, 4000
BelgiumSite Not Available
Medical Center "Cordis"
Pleven, 5800
BulgariaActive - Recruiting
Medical Center "Kordis"
Pleven, 5800
BulgariaSite Not Available
ASMC-IPSMC-skin and Veneral Diseases
Sofia, 1407
BulgariaSite Not Available
DCC "Fokus-5-LZIP" OOD
Sofia, 1463
BulgariaSite Not Available
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
BulgariaSite Not Available
Medical Military Academy MHAT Sofia
Sofia, 1606
BulgariaSite Not Available
MHAT Prof Stoyan Kirkovich AD
Stara Zagora, 6000
BulgariaSite Not Available
Alberta DermaSurgery Centre
Edmonton, Alberta T6G 1C3
CanadaSite Not Available
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Guelph Dermatology Research
Guelph, Ontario N1L 0B7
CanadaSite Not Available
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario L3Y 5G8
CanadaSite Not Available
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario L4B 1L1
CanadaSite Not Available
Centro Internacional de Estudios Clínicos (CIEC)
Comuna De Recoleta, 8420383
ChileSite Not Available
Clínica Dermacross S.A.
Vitacura, 7640881
ChileSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
The Second Xiangya Hospital Of Central South University
Changsha, 410011
ChinaSite Not Available
West China Hospital
Chengdu, 610041
ChinaSite Not Available
Southern Medical University Dermatology Hospital
Guangzhou, 510091
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
ChinaSite Not Available
Shanghai Skin Disease Hospital
Shanghai, 200000
ChinaSite Not Available
Xinjiang Uygur Autonomous Region People's Hospital
Urumqi, 830001
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
University Hospital Ostrava
Ostrava, 708 00
CzechiaSite Not Available
University Hospital Bulovka
Prague, 18081
CzechiaSite Not Available
Univ. Hospital Kralovske Vinohrady
Praha, 100 34
CzechiaSite Not Available
Aarhus University Hospital
Aarhus, 8200
DenmarkSite Not Available
Bispebjerg og Frederiksberg Hospital
København NV, 2400
DenmarkSite Not Available
Sjællands Universitetshospital
Roskilde, 4000
DenmarkSite Not Available
Suomen Terveystalo oy Tampere
Tampere, 33100
FinlandSite Not Available
HOP Privé Antony
Antony, 92160
FranceSite Not Available
HOP Edouard Herriot
Lyon, 69437
FranceSite Not Available
HOP Timone
Marseille, 13385
FranceSite Not Available
HOP l'Archet
Nice, 06200
FranceSite Not Available
HOP Saint-Louis
Paris, 75010
FranceSite Not Available
HOP la Milétrie
Poitiers, 86000
FranceSite Not Available
HOP Pontchaillou
Rennes, 35033
FranceSite Not Available
Fachklinik Bad Bentheim
Bad Bentheim, 48455
GermanySite Not Available
Charite Universitätsmedizin Berlin KöR
Berlin, 10117
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
GermanySite Not Available
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
GermanySite Not Available
Hautmedizin Saar
Merzig, 66663
GermanySite Not Available
Klinikum Oldenburg AöR
Oldenburg, 26133
GermanySite Not Available
Andreas Syggros Hospital of Cutaneous & Venereal Diseases
Athens, 16121
GreeceSite Not Available
Attikon University Hospital
Athens, 12462
GreeceSite Not Available
University General Hospital Attikon
Athens, 124 62
GreeceSite Not Available
General Hospital "G. Papageorgiou"
Thessaloniki, 56403
GreeceSite Not Available
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 54643
GreeceSite Not Available
Haemek Medical Center
Afula, 1834111
IsraelSite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Rabin Medical Center Beilinson
Petach Tikva, 49100
IsraelSite Not Available
Sheba MC
Ramat Gan, 52621
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80131
ItalySite Not Available
Università Federico II
Napoli, 80131
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
ItalySite Not Available
Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
Roma, 00167
ItalySite Not Available
Pol. Universitario Tor Vergata
Roma, 00133
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano (MI), 20089
ItalySite Not Available
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
JapanSite Not Available
Nagoya City University Hospital
Aichi, Nagoya, 467-8602
JapanSite Not Available
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
JapanSite Not Available
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
JapanSite Not Available
Kurume University Hospital
Fukuoka, Kurume, 830-0011
JapanSite Not Available
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502
JapanSite Not Available
Meiwa Hospital
Hyogo, Nishinomiya, 663-8186
JapanSite Not Available
University of Tsukuba Hospital
Ibaraki, Tsukuba, 305-8576
JapanSite Not Available
Tohoku University Hospital
Miyagi, Sendai, 980-8574
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, Okayama, 701-1192
JapanSite Not Available
Okayama University Hospital
Okayama, Okayama, 700-8558
JapanSite Not Available
University of the Ryukyus Hospital
Okinawa, Nakagami-gun, 903-0215
JapanSite Not Available
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
JapanSite Not Available
Shiga University of Medical Science Hospital
Shiga, Otsu, 520-2192
JapanSite Not Available
Dokkyo Medical University Hospital
Tochigi, Shimotsuga-gun, 321-0293
JapanSite Not Available
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655
JapanSite Not Available
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
JapanSite Not Available
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161
LithuaniaSite Not Available
Vilnius University Hospital, Santariskiu
Vilnius, 08411
LithuaniaSite Not Available
Hospital Pulau Pinang
Georgetown Pulau Pinang, 10990
MalaysiaSite Not Available
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990
MalaysiaSite Not Available
Hospital Sultan Ismail
Johor Bahru, 81100
MalaysiaSite Not Available
Hospital Sultanah Aminah
Johor Bahru, 80100
MalaysiaSite Not Available
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bahru, 15586
MalaysiaSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur, 50586
MalaysiaSite Not Available
Hospital Sultanah Nur Zahirah
Kuala Trengganu, 20400
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaSite Not Available
Sunway Medical Centre
Selangor Darul Ehsan, 47500
MalaysiaSite Not Available
Derma Norte del Bajio S.C.
Aguascalientes, 20127
MexicoSite Not Available
Grupo Clinico CATEI S.C.
Guadalajara, 44638
MexicoSite Not Available
Eukarya Pharmasite
Monterrey, 64718
MexicoSite Not Available
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
MexicoSite Not Available
Arke Estudios Clinicos SA de CV
Veracruz, 91910
MexicoSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
NetherlandsSite Not Available
Waikato Hospital
Hamilton, 3204
New ZealandSite Not Available
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011
NorwaySite Not Available
Southern Philippines Medical Center
Davao City, 8000
PhilippinesSite Not Available
Southern Philippines Medical Center -Davao-62091
Davao City, 8000
PhilippinesSite Not Available
Center for Skin Research, Testing and Product Development
Makati City, 1200
PhilippinesSite Not Available
Philippine General Hospital
Manila, Philippines, 1000
PhilippinesSite Not Available
East Avenue Medical Center
Quezon City, 1100
PhilippinesSite Not Available
Non-Public Health Care Facility LABDERM
Ossy, 42624
PolandSite Not Available
NSZOZ Termedica Clinical Research Center
Poznan, 60-681
PolandSite Not Available
Frederic Chopin University Hospital No. 1 in Rzeszow
Rzeszow, 35055
PolandSite Not Available
High-Med Specialist Clinic, Warsaw
Warsaw, 01-817
PolandSite Not Available
National Medical Institute MSWiA
Warsaw, 02-507
PolandSite Not Available
Provita Clinic
Warsaw, 02-647
PolandSite Not Available
Royalderm
Warszawa, 02-962
PolandSite Not Available
Centrum Zdrowia WroMedica
Wroclaw, 51-685
PolandSite Not Available
ULS Braga
Braga, 4710-243
PortugalSite Not Available
Hospital CUF Descobertas-Lisboa-49820
Lisboa, 1998-018
PortugalSite Not Available
ULS de Santa Maria, E.P.E
Lisboa, 1649-035
PortugalSite Not Available
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisboa, 1169-050
PortugalSite Not Available
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, 4050
PortugalSite Not Available
National University Hospital
Singapore, 119074
SingaporeSite Not Available
National University Hospital-Singapore-42005
Singapore, 119074
SingaporeSite Not Available
DOST sro - Sanatorium-Type Dermatovenereological Department
Svidnik, 089 01
SlovakiaSite Not Available
FN Trnava
Trnava, 91702
SlovakiaSite Not Available
TASK Applied Science
Cape Town, 7530
South AfricaSite Not Available
Hospital Santa Creu i Sant Pau
Barcelona, 08026
SpainSite Not Available
Hospital Universitario Reina Sofía
Córdoba, 14004
SpainActive - Recruiting
Hospital Universitario Reina Sofía-Córdoba-40500
Córdoba, 14004
SpainSite Not Available
Hospital Universitario San Cecilio
Granada, 18012
SpainSite Not Available
Hospital General de Granollers
Granollers, 08402
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28009
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital de Manises
Manises, 46940
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Miguel Servet
Zaragoza, 50009
SpainSite Not Available
University Hospital Basel
Basel, 4055
SwitzerlandSite Not Available
University Hospital Bern/Inselspital Bern
Bern, 3010
SwitzerlandSite Not Available
Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie
Geneve, 1205
SwitzerlandSite Not Available
University Hospital Zurich
Zürich, 8091
SwitzerlandSite Not Available
Chang Gung Memorial Hospital(Linkou)
TaoYuan, 333
TaiwanSite Not Available
SBU Gulhane Training and Research Hospital
Ankara, 06011
TurkeySite Not Available
Akdeniz University Medical Faculty
Antalya, 7070
TurkeySite Not Available
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55270
TurkeySite Not Available
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
United KingdomSite Not Available
St George's Hospital
London, SW17 0QT
United KingdomActive - Recruiting
St George's Hospital-London-26733
London, SW17 0QT
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
First QC Dermatology
Fountain Valley, California 92708
United StatesActive - Recruiting
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Integrative Skin Science and Research
Sacramento, California 95815
United StatesActive - Recruiting
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California 95815
United StatesSite Not Available
Clinical Trials Research Institute
Thousand Oaks, California 91320
United StatesSite Not Available
Ziaderm Research
North Miami Beach, Florida 33162
United StatesSite Not Available
ForCare Clinical Research, Inc.
Tampa, Florida 33613
United StatesSite Not Available
Olympian Clinical Research
Tampa, Florida 33615
United StatesActive - Recruiting
Olympian Clinical Research-Tampa-69560
Tampa, Florida 33615
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana 46250
United StatesSite Not Available
Indiana Clinical and Translational Sciences Institute Clinical Research Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Skin Sciences, PLLC
Louisville, Kentucky 40217
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesSite Not Available
Oakland Hills Dermatology, PC
Auburn Hills, Michigan 48326
United StatesSite Not Available
MediSearch Clinical Trials
Saint Joseph, Missouri 64506
United StatesSite Not Available
Skin Specialists, P.C.
Omaha, Nebraska 68144
United StatesSite Not Available
Advantage Clinical Trials-Bronx-69770
Bronx, New York 10467
United StatesSite Not Available
Dermatology at Lake Success
Lake Success, New York 11042
United StatesSite Not Available
AXIS Clinicals
Fargo, North Dakota 58103
United StatesSite Not Available
University Hospitals of Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
Epic Medical Research
Chickasha, Oklahoma 73018
United StatesSite Not Available
Unity Clinical Research
Oklahoma City, Oklahoma 73118
United StatesSite Not Available
Dermatology Research Center of Oklahoma
Tulsa, Oklahoma 74136
United StatesSite Not Available
Oregon Health and Sciences University
Portland, Oregon 97239
United StatesSite Not Available
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Palmetto Clinical Trial Services
Greenville, South Carolina 29615
United StatesSite Not Available
Center for Clinical Studies
Houston, Texas 77004
United StatesSite Not Available
Center for Clinical Studies-Houston-58806
Houston, Texas 77004
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
University of Utah Health
Murray, Utah 84107
United StatesSite Not Available
Dermatology Specialists of Spokane
Spokane, Washington 99202
United StatesSite Not Available
HCMC Hospital of Dermato-Venereology
Ho Chi Minh, 70000
VietnamSite Not Available
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh, 70000
VietnamSite Not Available
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