Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819398
• Other study ID #: 1368-0098
• Secondary ID: 2022-501074-19-0
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 10, 2023
• Est. completion date: August 29, 2028

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Main endpoints for Part 2 will be supported by Part 1 results available at time of primary analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 29, 2028
• Est. primary completion date: September 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Spesolimab Formulation 1
Spesolimab Formulation 1
• Spesolimab Formulation 2
Spesolimab Formulation 2
• Placebo matching Spesolimab Formulation 1
Placebo matching Spesolimab Formulation 1
• Placebo matching Spesolimab Formulation 2
Placebo matching Spesolimab Formulation 2

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Caba
Argentina	STAT Research	Caba
Argentina	Hospital Alemán	Capital Federal
Argentina	Centro de Investigaciones Médicas 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
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	AKH - Medical University of Vienna	Vienna
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Bulgaria	Medical Center "Kordis"	Pleven
Bulgaria	ASMC-IPSMC-skin and Veneral Diseases	Sofia
Bulgaria	DCC "Fokus-5-LZIP" OOD	Sofia
Bulgaria	Diagnostic Consultative Center Alexandrovska	Sofia
Bulgaria	Medical Military Academy MHAT Sofia	Sofia
Bulgaria	MHAT Prof Stoyan Kirkovich AD	Stara Zagora
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Barrie	Ontario
Canada	Alberta DermaSurgery Centre	Edmonton	Alberta
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
Chile	Centro Internacional de Estudios Clínicos (CIEC)	Comuna De Recoleta
Chile	Clínica Dermacross S.A.	Vitacura
China	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	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	Urumqi
China	Wuhan Union Hospital	Wuhan
Czechia	University Hospital Ostrava	Ostrava
Czechia	University Hospital Bulovka	Prague
Czechia	Univ. Hospital Kralovske Vinohrady	Praha
Denmark	Aarhus University Hospital	Aarhus
Denmark	Bispebjerg og Frederiksberg Hospital	København NV
Denmark	Sjællands Universitetshospital	Roskilde
Finland	Suomen Terveystalo oy Tampere	Tampere
France	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
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Katholisches Klinikum Bochum gGmbH	Bochum
Germany	Universitätsmedizin Göttingen, Georg-August-Universität	Göttingen
Germany	Hautmedizin Saar	Merzig
Germany	Klinikum Oldenburg AöR	Oldenburg
Greece	Andreas Syggros Hospital of Cutaneous & Venereal Diseases	Athens
Greece	Attikon University Hospital	Athens
Greece	University General Hospital Attikon	Athens
Greece	General Hospital "G. Papageorgiou"	Thessaloniki
Greece	General Hospital of Thessaloniki "Ippokrateio"	Thessaloniki
Israel	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
Italy	Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico	Milano
Italy	AOU Università degli Studi della Campania Luigi Vanvitelli	Napoli
Italy	Università Federico II	Napoli
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Istituto Dermopatico Dell'Immacolata - IDI - IRCCS	Roma
Italy	Pol. Universitario Tor Vergata	Roma
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Japan	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	National Hospital Organization Okayama Medical Center	Okayama, Okayama
Japan	Okayama University Hospital	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	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
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas
Lithuania	Vilnius University Hospital, Santariskiu	Vilnius
Malaysia	Hospital Pulau Pinang	Georgetown Pulau Pinang
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	Hospital Sultanah Aminah	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
Mexico	Derma Norte del Bajio S.C.	Aguascalientes
Mexico	Grupo Clinico CATEI S.C.	Guadalajara
Mexico	Eukarya Pharmasite	Monterrey
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Mexico	Arke Estudios Clinicos SA de CV	Veracruz
Netherlands	Universitair Medisch Centrum Groningen	Groningen
New Zealand	Waikato Hospital	Hamilton
Philippines	Southern Philippines Medical Center	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
Poland	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
Singapore	National University Hospital	Singapore
Slovakia	DOST sro - Sanatorium-Type Dermatovenereological Department	Svidnik
Slovakia	FN Trnava	Trnava
South Africa	TASK Applied Science	Cape Town
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Reina Sofía	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
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Bern/Inselspital Bern	Bern
Switzerland	Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie	Geneve
Taiwan	Chang Gung Memorial Hospital(Linkou)	TaoYuan
Turkey	SBU Gulhane Training and Research Hospital	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi	Samsun
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	St George's Hospital	London
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Oakland Hills Dermatology, PC	Auburn Hills	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	AXIS Clinicals	Fargo	North Dakota
United States	First OC Dermatology	Fountain Valley	California
United States	Palmetto Clinical Trial Services	Greenville	South Carolina
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Dermatology Research Associates	Los Angeles	California
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Ziaderm Research	North Miami Beach	Florida
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Skin Specialists, P.C.	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Integrative Skin Science and Research	Sacramento	California
United States	Progressive Clinical Research	San Antonio	Texas
United States	ForCare Clinical Research, Inc.	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Clinical Trials Research Institute	Thousand Oaks	California
Vietnam	HCMC Hospital of Dermato-Venereology	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Philippines,  Poland,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8		At baseline and at week 8
Secondary	Part 1: Percent change from baseline in dT count at Week 16 (part 1)		At baseline and at week 16
Secondary	Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value 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.	At baseline and at week 8
Secondary	Part 1: Absolute change from baseline in IHS4 value at Week 16		At baseline and at week 16
Secondary	Part 1: Occurrence of treatment emergent adverse events (TEAEs)		up to 64 weeks

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