Clinical trial NCT05819398: Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hidradenitis Suppurativa
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Of full age of consent at screening.
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.
8. Total dT count of at least 1 at Baseline visit. Further inclusion criteria apply.

Exclusion Criteria:

1. 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.
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.

Further exclusion criteria apply.

Primary outcomes:
measure: Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8
timeFrame: At baseline and at week 8
Secondary outcomes:
measure: Part 1: Percent change from baseline in dT count at Week 16 (part 1)
timeFrame: At baseline and at week 16
measure: Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8
timeFrame: At baseline and at week 8
measure: Part 1: Absolute change from baseline in IHS4 value at Week 16
timeFrame: At baseline and at week 16
measure: Part 1: Occurrence of treatment emergent adverse events (TEAEs)
timeFrame: up to 64 weeks
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research-Sacramento-69402
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: North Miami Beach
country: United States
facility: Ziaderm Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research-Tampa-69560
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology, PC
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Fargo
country: United States
facility: AXIS Clinicals
state: North Dakota
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Houston
country: United States
facility: Center for Clinical Studies-Houston-58806
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Caba
country: Argentina
facility: STAT Research
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Capital Federal
country: Argentina
facility: Hospital Alemán
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
city: Rosario
country: Argentina
facility: Instituto de Especialidades de la Salud Rosario
city: San Miguel de Tucumán
country: Argentina
facility: Sanatorio 9 de Julio S.A.
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Pleven
country: Bulgaria
facility: Medical Center "Kordis"
city: Sofia
country: Bulgaria
facility: ASMC-IPSMC-skin and Veneral Diseases
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Alexandrovska
city: Sofia
country: Bulgaria
facility: DCC "Fokus-5-LZIP" OOD
city: Sofia
country: Bulgaria
facility: Medical Military Academy MHAT Sofia
city: Stara Zagora
country: Bulgaria
facility: MHAT Prof Stoyan Kirkovich AD
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Comuna De Recoleta
country: Chile
facility: Centro Internacional de Estudios Clínicos (CIEC)
city: Vitacura
country: Chile
facility: Clínica Dermacross S.A.
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: Southern Medical University Dermatology Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: University Hospital Bulovka
city: Praha
country: Czechia
facility: Univ. Hospital Kralovske Vinohrady
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: København NV
country: Denmark
facility: Bispebjerg og Frederiksberg Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Tampere
country: Finland
facility: Suomen Terveystalo oy Tampere
city: Antony
country: France
facility: HOP Privé Antony
city: Lyon
country: France
facility: HOP Edouard Herriot
city: Marseille
country: France
facility: HOP Timone
city: Nice
country: France
facility: HOP l'Archet
city: Paris
country: France
facility: HOP Saint-Louis
city: Poitiers
country: France
facility: HOP la Milétrie
city: Rennes
country: France
facility: HOP Pontchaillou
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
city: Merzig
country: Germany
facility: Hautmedizin Saar
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Athens
country: Greece
facility: Attikon University Hospital
city: Athens
country: Greece
facility: Andreas Syggros Hospital of Cutaneous & Venereal Diseases
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ippokrateio"
city: Thessaloniki
country: Greece
facility: General Hospital "G. Papageorgiou"
city: Afula
country: Israel
facility: Haemek Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Ramat Gan
country: Israel
facility: Sheba MC
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania Luigi Vanvitelli
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Roma
country: Italy
facility: Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
city: Aichi, Nagoya
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
city: Aichi, Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Aichi, Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Gifu, Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Hyogo, Nishinomiya
country: Japan
facility: Meiwa Hospital
city: Ibaraki, Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Okayama, Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama, Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Okinawa, Ginowan
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka, Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Shiga, Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Tochigi, Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo, Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital, Santariskiu
city: Georgetown Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang-Pulau Pinang-21953
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kota Bahru
country: Malaysia
facility: Hospital Raja Perempuan Zainab II, Kota Bharu
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Trengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Selangor Darul Ehsan
country: Malaysia
facility: Sunway Medical Centre
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajio S.C.
city: Guadalajara
country: Mexico
facility: Grupo Clinico CATEI S.C.
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite
city: Veracruz
country: Mexico
facility: Arke Estudios Clinicos SA de CV
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Davao City
country: Philippines
facility: Southern Philippines Medical Center -Davao-62091
city: Makati City
country: Philippines
facility: Center for Skin Research, Testing and Product Development
city: Manila, Philippines
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
city: Ossy
country: Poland
facility: Non-Public Health Care Facility LABDERM
city: Poznan
country: Poland
facility: NSZOZ Termedica Clinical Research Center
city: Rzeszow
country: Poland
facility: Frederic Chopin University Hospital No. 1 in Rzeszow
city: Warsaw
country: Poland
facility: High-Med Specialist Clinic, Warsaw
city: Warsaw
country: Poland
facility: National Medical Institute MSWiA
city: Warsaw
country: Poland
facility: Provita Clinic
city: Warszawa
country: Poland
facility: Royalderm
city: Wroclaw
country: Poland
facility: Centrum Zdrowia WroMedica
city: Singapore
country: Singapore
facility: National University Hospital-Singapore-42005
city: Svidnik
country: Slovakia
facility: DOST sro - Sanatorium-Type Dermatovenereological Department
city: Trnava
country: Slovakia
facility: FN Trnava
city: Cape Town
country: South Africa
facility: TASK Applied Science
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía-Córdoba-40500
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granollers
country: Spain
facility: Hospital General de Granollers
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Manises
country: Spain
facility: Hospital de Manises
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario De Santiago
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern/Inselspital Bern
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie
city: TaoYuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
city: Ankara
country: Turkey
facility: SBU Gulhane Training and Research Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: St George's Hospital-London-26733
city: Ho Chi Minh
country: Vietnam
facility: HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Study officials:
References: