Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Hidradenitis Suppurativa
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria: 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. Total AN count of greater than or equal to 5. Total dT count of at least 1 at Baseline visit. Further criteria apply. Exclusion Criteria: 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 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 criteria apply.
Sites / Locations
- First QC DermatologyRecruiting
- Dermatology Research AssociatesRecruiting
- Integrative Skin Science and ResearchRecruiting
- Clinical Trials Research InstituteRecruiting
- ForCare Clinical Research, Inc.Recruiting
- Olympian Clinical ResearchRecruiting
- Dawes Fretzin Clinical Research Group, LLCRecruiting
- Skin Specialists, P.C.Recruiting
- Medical University of South CarolinaRecruiting
- Palmetto Clinical Trial ServicesRecruiting
- Center for Clinical StudiesRecruiting
- Progressive Clinical ResearchRecruiting
- STAT ResearchRecruiting
- Hospital Italiano de Buenos AiresRecruiting
- Hospital AlemánRecruiting
- Centro de Investigaciones Médicas Mar del PlataRecruiting
- Instituto de Especialidades de la Salud RosarioRecruiting
- Sanatorio 9 de Julio S.A.Recruiting
- Holdsworth House Medical PracticeRecruiting
- Westmead HospitalRecruiting
- Alfred HospitalRecruiting
- Brussels - UNIV Saint-LucRecruiting
- Centre Hospitalier Universitaire de LiègeRecruiting
- Medical Center "Cordis"Recruiting
- ASMC-IPSMC-skin and Veneral DiseasesRecruiting
- Medical Military Academy MHAT SofiaRecruiting
- MHAT Prof Stoyan Kirkovich ADRecruiting
- Alberta DermaSurgery CentreRecruiting
- SimcoDerm Medical and Surgical Dermatology CentreRecruiting
- Guelph Dermatology ResearchRecruiting
- Dr. S. K. Siddha Medicine Professional CorporationRecruiting
- York Dermatology Clinic and Research CentreRecruiting
- Centro Internacional de Estudios Clínicos (CIEC)Recruiting
- Clínica Dermacross S.A.Recruiting
- Bispebjerg og Frederiksberg HospitalRecruiting
- Sjællands UniversitetshospitalRecruiting
- Suomen Terveystalo oy TampereRecruiting
- HOP Privé AntonyRecruiting
- HOP Edouard HerriotRecruiting
- HOP TimoneRecruiting
- HOP l'ArchetRecruiting
- HOP Saint-LouisRecruiting
- HOP la MilétrieRecruiting
- HOP PontchaillouRecruiting
- Fachklinik Bad BentheimRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- Katholisches Klinikum Bochum gGmbHRecruiting
- Universitätsmedizin Göttingen, Georg-August-UniversitätRecruiting
- Hautmedizin SaarRecruiting
- Klinikum Oldenburg AöRRecruiting
- Haemek Medical CenterRecruiting
- Sheba MCRecruiting
- Pol. Universitario Tor VergataRecruiting
- Istituto Dermopatico Dell'Immacolata - IDI - IRCCSRecruiting
- Japan Community Healthcare Organization Chukyo HospitalRecruiting
- Nagoya City University HospitalRecruiting
- Fujita Health University HospitalRecruiting
- Fukuoka University HospitalRecruiting
- Kurume University HospitalRecruiting
- Ogaki Municipal HospitalRecruiting
- Meiwa HospitalRecruiting
- University of Tsukuba HospitalRecruiting
- Tohoku University HospitalRecruiting
- Okayama University HospitalRecruiting
- National Hospital Organization Okayama Medical CenterRecruiting
- University of the Ryukyus HospitalRecruiting
- Kansai Medical University HospitalRecruiting
- Shiga University of Medical Science HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- The University of Tokyo HospitalRecruiting
- Nihon University Itabashi HospitalRecruiting
- Tokyo Medical University HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Hallym University Kangnam Sacred Heart HospitalRecruiting
- Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
- Vilnius University Hospital, SantariskiuRecruiting
- Hospital Pulau PinangRecruiting
- Hospital Sultanah AminahRecruiting
- Hospital Sultan IsmailRecruiting
- Hospital Raja Perempuan Zainab II, Kota BharuRecruiting
- Hospital Kuala LumpurRecruiting
- Hospital Sultanah Nur ZahirahRecruiting
- Sarawak General HospitalRecruiting
- Sunway Medical CentreRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Waikato HospitalRecruiting
- Center for Skin Research, Testing and Product DevelopmentRecruiting
- Non-Public Health Care Facility LABDERMRecruiting
- High-Med Specialist Clinic, WarsawRecruiting
- National Medical Institute MSWiARecruiting
- Provita ClinicRecruiting
- RoyaldermRecruiting
- Centrum Zdrowia WroMedicaRecruiting
- National University HospitalRecruiting
- DOST sro - Sanatorium-Type Dermatovenereological DepartmentRecruiting
- TASK Applied ScienceRecruiting
- Hospital Santa Creu i Sant PauRecruiting
- Hospital Universitario Reina SofíaRecruiting
- Hospital Universitario San CecilioRecruiting
- Hospital General de GranollersRecruiting
- Hospital General Universitario Gregorio MarañónRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital de ManisesRecruiting
- Hospital Universitario de SalamancaRecruiting
- Complexo Hospitalario Universitario De SantiagoRecruiting
- Hospital Miguel ServetRecruiting
- University Hospital Bern/Inselspital BernRecruiting
- Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Part I: Low dose group
Part I: Medium dose group
Part I: High dose group
Part I: Placebo group
Part II: Active (treatment) group
Part II: Placebo group