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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Spesolimab i.v.; Drug: Spesolimab s.c.; Drug: Placebo matching Spesolimab i.v.; Drug: Placebo matching Spesolimab s.c.

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1023AAB
    • Stat Research
  • CABA, Argentina, C1056AB
    • Hospital Italiano de Buenos Aires
  • Capital Federal, Argentina, C1118AAT
    • Hospital Alemán
  • Mar del Plata, Argentina, 7600
    • Centro de Investigaciones Medicas Mar del Plata
  • Rosario, Argentina, 2000
    • Instituto de Especialidades de la Salud Rosario
  • San Miguel de Tucumán, Argentina, 4000
    • Sanatorio 9 de Julio S.A.
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
• Austria
  • Vienna, Austria, 1090
    • AKH - Medical University of Vienna
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center "Kordis"
  • Sofia, Bulgaria, 1606
    • Medical Military Academy MHAT Sofia
  • Sofia, Bulgaria, 1407
    • ASMC-IPSMC-skin and Veneral Diseases
  • Sofia, Bulgaria, 1431
    • Diagnostic Consultative Center Alexandrovska
  • Sofia, Bulgaria, 1463
    • DCC "Fokus-5-LZIP" OOD
  • Stara Zagora, Bulgaria, 6000
    • MHAT Prof Stoyan Kirkovich AD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta Dermasurgery Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Simcoderm Medical and Surgical Dermatology Centre
    • Guelph, Ontario, Canada, N1L 0B7
      • Guelph Dermatology Research
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S. K. Siddha Medicine Professional Corporation
    • Richmond Hill, Ontario, Canada, L4B 1L1
      • York Dermatology Clinic and Research Centre
• Chile
  • Comuna de Recoleta, Chile, 8420383
    • Centro Internacional de Estudios Clínicos (CIEC)
  • Vitacura, Chile, 7640881
    • Clinica Dermacross S.A.
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410011
    • The Second Xiangya Hospital Of Central South University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Guangzhou, China, 510091
    • Southern Medical University Dermatology Hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, Zhejiang University
  • Shanghai, China, 200000
    • Shanghai skin disease hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Ürümqi, China, 830001
    • Xinjiang Uygur Autonomous Region People's Hospital
• Czechia
  • Ostrava, Czechia, 708 00
    • University Hospital Ostrava
  • Plzen-Bory, Czechia, 30100
    • Fakultni nemocnice Plzen
  • Prague, Czechia, 18081
    • University Hospital Bulovka
  • Prague, Czechia, 100 34
    • Univ. Hospital Kralovske Vinohrady
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • København NV, Denmark, 2400
    • Bispebjerg og Frederiksberg Hospital
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital
• Finland
  • Tampere, Finland, 33100
    • Suomen Terveystalo oy Tampere
• France
  • Antony, France, 92160
    • HOP Privé Antony
  • Lyon, France, 69437
    • HOP Edouard Herriot
  • Marseille, France, 13385
    • HOP Timone
  • Nice, France, 06200
    • HOP l'Archet
  • Paris, France, 75010
    • HOP Saint-Louis
  • Poitiers, France, 86000
    • HOP la Milétrie
  • Rennes, France, 35033
    • HOP Pontchaillou
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin KöR
  • Bochum, Germany, 44791
    • Katholisches Klinikum Bochum gGmbH
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen, Georg-August-Universität
  • Merzig, Germany, 66663
    • Hautmedizin Saar
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR
• Greece
  • Athens, Greece, 124 62
    • University General Hospital Attikon
  • Athens, Greece, 12462
    • Attikon University Hospital
  • Athens, Greece, 16121
    • Andreas Syggros Hospital of Cutaneous & Venereal Diseases
  • Thessaloniki, Greece, 54643
    • General Hospital of Thessaloniki "Ippokrateio"
  • Thessaloniki, Greece, 56403
    • General Hospital Of Thessaloniki Papageorgiou
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Beilinson
  • Ramat Gan, Israel, 52621
    • Sheba MC
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
• Italy
  • Napoli, Italy, 80131
    • AOU Università degli Studi della Campania Luigi Vanvitelli
  • Pisa, Italy, 56126
    • Azienda Ospedaliera Universitaria Pisana
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
  • Roma, Italy, 00167
    • Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
• Japan
  • Aichi, Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Aichi, Nagoya, Japan, 457-8510
    • Japan Community Healthcare Organization Chukyo Hospital
  • Aichi, Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukuoka, Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Gifu, Ogaki, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Hyogo, Nishinomiya, Japan, 663-8186
    • Meiwa Hospital
  • Ibaraki, Tsukuba, Japan, 305-8576
    • University of Tsukuba Hospital
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Okayama, Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Okinawa, Ginowan, Japan, 901-2725
    • University of the Ryukyus Hospital
  • Osaka, Hirakata, Japan, 573-1191
    • Kansai Medical University Hospital
  • Shiga, Otsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital
  • Tochigi, Shimotsuga-gun, Japan, 321-0293
    • Dokkyo Medical University Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8655
    • The University of Tokyo Hospital
  • Tokyo, Itabashi-ku, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Vilnius, Lithuania, 08411
    • Vilnius University Hospital, Santariskiu
• Malaysia
  • Georgetown Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang-Pulau Pinang-21953
  • Johor Bahru, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Johor Bahru, Malaysia, 81100
    • Hospital Sultan Ismail
  • Kota Bharu, Malaysia, 15586
    • Hospital Raja Perempuan Zainab II, Kota Bharu
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Terengganu, Malaysia, 20400
    • Hospital Sultanah Nur Zahirah
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Selangor Darul Ehsan, Malaysia, 47500
    • Sunway Medical Centre
• Mexico
  • Aguascalientes, Mexico, 20127
    • Derma Norte del Bajio S.C.
  • Guadalajara, Mexico, 44638
    • Grupo Clínico CATEI S.C.
  • Monterrey, Mexico, 64460
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Monterrey, Mexico, 64718
    • Eukarya PharmaSite
  • Veracruz, Mexico, 91910
    • Arke SMO S.A. de C.V.
• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Universitair Medisch Centrum Groningen
• New Zealand
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
• Philippines
  • Davao City, Philippines, 8000
    • Southern Philippines Medical Center -Davao-62091
  • Makati City, Philippines, 1200
    • Center for Skin Research, Testing and Product Development
  • Manila, Philippines, Philippines, 1000
    • Philippine General Hospital
  • Quezon City, Philippines, 1100
    • East Avenue Medical Center
• Poland
  • Ossy, Poland, 42624
    • Non-Public Health Care Facility LABDERM
  • Poznan, Poland, 60-681
    • NSZOZ Termedica Clinical Research Center
  • Rzeszów, Poland, 35055
    • Frederic Chopin University Hospital No. 1 in Rzeszow
  • Warsaw, Poland, 02-507
    • National Medical Institute MSWiA
  • Warsaw, Poland, 01-817
    • High-Med Specialist Clinic, Warsaw
  • Warsaw, Poland, 02-647
    • Provita Clinic
  • Warsaw, Poland, 02-962
    • Royalderm
  • Wroclaw, Poland, 51-685
    • Centrum Zdrowia WroMedica
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital-Singapore-42005
• Slovakia
  • Svidník, Slovakia, 089 01
    • DOST sro - Sanatorium-Type Dermatovenereological Department
  • Trnava, Slovakia, 91702
    • FN Trnava
• South Africa
  • Cape Town, South Africa, 7530
    • TASK Applied Science
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 07441
    • Hallym University Kangnam Sacred Heart Hospital
• Spain
  • Barcelona, Spain, 08026
    • Hospital Santa Creu i Sant Pau
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía-Córdoba-40500
  • Granada, Spain, 18012
    • Hospital Universitario San Cecilio
  • Granollers, Spain, 08402
    • Hospital General De Granollers
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañón
  • Manises, Spain, 46940
    • Hospital de Manises
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Santiago de Compostela, Spain, 15706
    • Complexo Hospitalario Universitario De Santiago
  • Zaragoza, Spain, 50009
    • Hospital Miguel Servet
• Switzerland
  • Basel, Switzerland, 4055
    • Universitätsspital Basel
  • Bern, Switzerland, 3010
    • University Hospital Bern/Inselspital Bern
  • Geneva, Switzerland, 1205
    • Hopitaux Universitaires Geneve (HUG)
• Taiwan
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06011
    • SBU Gulhane Training and Research Hospital
  • Antalya, Turkey (Türkiye), 7070
    • Akdeniz University Medical Faculty
  • Samsun, Turkey (Türkiye), 55270
    • Ondokuz Mayis Universitesi Tip Fakultesi
• United Kingdom
  • Gloucester, United Kingdom, GL1 3NN
    • Gloucestershire Royal Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital-London-26733
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research-Sacramento-69402
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Florida
    • North Miami Beach, Florida, United States, 33162
      • Ziaderm Research
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research, Inc.
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research-Tampa-69560
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology, PC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, P.C.
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Axis Clinicals
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • Palmetto Clinical Trial Services
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies-Houston-58806
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spesolimab low dose group; Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Drug: Spesolimab i.v.; Weekly dose of spesolimab via i.v. for 4 weeks.; Other Names: Spevigo®; Drug: Spesolimab s.c.; Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.; Other Names: Spevigo®
Experimental: Spesolimab medium dose group; Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Drug: Spesolimab i.v.; Weekly dose of spesolimab via i.v. for 4 weeks.; Other Names: Spevigo®; Drug: Spesolimab s.c.; Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.; Other Names: Spevigo®
Experimental: Spesolimab high dose group; Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Drug: Spesolimab i.v.; Weekly dose of spesolimab via i.v. for 4 weeks.; Other Names: Spevigo®; Drug: Spesolimab s.c.; Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.; Other Names: Spevigo®
Placebo Comparator: Placebo; Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Drug: Spesolimab s.c.; Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.; Other Names: Spevigo®; Drug: Placebo matching Spesolimab i.v.; Weekly dose of placebo via i.v. for 4 weeks.; Drug: Placebo matching Spesolimab s.c.; Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8	Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline. Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.	The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16	Percent change from baseline in draining fistula/tunnel (dT) count at Week 16 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.	The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8	IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline). Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.	The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16	IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline). Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.	The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)	The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs.	From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: 1368-0098; 2022-501074-19-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

• IPD Sharing Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No