Hidradenitis SuppurativaPhase 2/3NCT05819398
Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
A Phase 2/3 study testing Spesolimab i.v. and Spesolimab s.c. in people with Hidradenitis Suppurativa, run by Boehringer Ingelheim at 162 sites in 35 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Spesolimab i.v. and Spesolimab s.c.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 162 sitesin 35 countries
- Study dates
- 17 Apr 2023to 31 Mar 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 in the last 1 year prior to the Baseline visit, as per investigator discretion. All participants must have previous exposure to antibiotics 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.
Who cannot join
- 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/immunomodulatory 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.
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- 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 exclusion criteria apply.
Trial locations and contacts
162 sites in 35 countries.
162 sites in 35 countries
United States19 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, 48326
Medical University of South Carolina
Charleston, South Carolina, 29425
AXIS Clinicals
Fargo, North Dakota, 58103
First OC Dermatology
Fountain Valley, California, 92708
Palmetto Clinical Trial Services
Greenville, South Carolina, 29615
Center for Clinical Studies-Houston-58806
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, 46250
Dermatology Research Associates
Los Angeles, California, 90045
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Ziaderm Research
North Miami Beach, Florida, 33162
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Skin Specialists, P.C.
Omaha, Nebraska, 68144
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Integrative Skin Science and Research-Sacramento-69402
Sacramento, California, 95815
Progressive Clinical Research
San Antonio, Texas, 78213
ForCare Clinical Research, Inc.
Tampa, Florida, 33613
Olympian Clinical Research-Tampa-69560
Tampa, Florida, 33615
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Japan18 sites
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Nagoya City University Hospital
Aichi, Nagoya, 467-8602
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502
Meiwa Hospital
Hyogo, Nishinomiya, 663-8186
University of Tsukuba Hospital
Ibaraki, Tsukuba, 305-8576
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Okayama University Hospital
Okayama, Okayama, 700-8558
National Hospital Organization Okayama Medical Center
Okayama, Okayama, 701-1192
University of the Ryukyus Hospital
Okinawa, Ginowan, 901-2725
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
Shiga University of Medical Science Hospital
Shiga, Otsu, 520-2192
Dokkyo Medical University Hospital
Tochigi, Shimotsuga-gun, 321-0293
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Spain10 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitario Reina Sofía-Córdoba-40500
Córdoba, 14004
Hospital Universitario San Cecilio
Granada, 18012
Hospital General de Granollers
Granollers, 08402
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital de Manises
Manises, 46940
Hospital Universitario de Salamanca
Salamanca, 37007
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706
Hospital Miguel Servet
Zaragoza, 50009
China9 sites
Peking University First Hospital
Beijing, 100034
The First Hospital of Jilin University
Changchun, 130021
The Second Xiangya Hospital Of Central South University
Changsha, 410011
West China Hospital of Sichuan University
Chengdu, 610041
Southern Medical University Dermatology Hospital
Guangzhou, 510091
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Shanghai Skin Disease Hospital
Shanghai, 200000
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, 830001
Wuhan Union Hospital
Wuhan, 430022
Malaysia8 sites
Hospital Pulau Pinang-Pulau Pinang-21953
Georgetown Pulau Pinang, 10990
Hospital Sultanah Aminah
Johor Bahru, 80100
Hospital Sultan Ismail
Johor Bahru, 81100
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bharu, 15586
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Sultanah Nur Zahirah
Kuala Terengganu, 20400
Sarawak General Hospital
Kuching, 93586
Sunway Medical Centre
Selangor Darul Ehsan, 47500
Poland8 sites
Non-Public Health Care Facility LABDERM
Ossy, 42624
NSZOZ Termedica Clinical Research Center
Poznan, 60-681
Frederic Chopin University Hospital No. 1 in Rzeszow
Rzeszów, 35055
High-Med Specialist Clinic, Warsaw
Warsaw, 01-817
National Medical Institute MSWiA
Warsaw, 02-507
Provita Clinic
Warsaw, 02-647
Royalderm
Warsaw, 02-962
Centrum Zdrowia WroMedica
Wroclaw, 51-685
France7 sites
HOP Privé Antony
Antony, 92160
HOP Edouard Herriot
Lyon, 69437
HOP Timone
Marseille, 13385
HOP l'Archet
Nice, 06200
HOP Saint-Louis
Paris, 75010
HOP la Milétrie
Poitiers, 86000
HOP Pontchaillou
Rennes, 35033
Argentina6 sites
STAT Research
CABA, C1023AAB
Hospital Italiano de Buenos Aires
CABA, C1056AB
Hospital Alemán
Capital Federal, C1118AAT
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, 7600
Instituto de Especialidades de la Salud Rosario
Rosario, 2000
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán, 4000
Bulgaria6 sites
Medical Center "Kordis"
Pleven, 5800
ASMC-IPSMC-skin and Veneral Diseases
Sofia, 1407
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
DCC "Fokus-5-LZIP" OOD
Sofia, 1463
Medical Military Academy MHAT Sofia
Sofia, 1606
MHAT Prof Stoyan Kirkovich AD
Stara Zagora, 6000
Germany6 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Charite Universitätsmedizin Berlin KöR
Berlin, 10117
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Hautmedizin Saar
Merzig, 66663
Klinikum Oldenburg AöR
Oldenburg, 26133
Canada5 sites
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4B 1L1
Greece5 sites
University General Hospital Attikon
Athens, 124 62
Attikon University Hospital
Athens, 12462
Andreas Syggros Hospital of Cutaneous & Venereal Diseases
Athens, 16121
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 54643
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, 56403
Israel5 sites
Haemek Medical Center
Afula, 1834111
Rambam Health Care Campus
Haifa, 3109601
Rabin Medical Center Beilinson
Petah Tikva, 49100
Sheba MC
Ramat Gan, 52621
Sourasky Medical Center
Tel Aviv, 64239
Mexico5 sites
Derma Norte del Bajio S.C.
Aguascalientes, 20127
Grupo Clinico CATEI S.C.
Guadalajara, 44638
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Eukarya Pharmasite
Monterrey, 64718
Arke SMO S.A. de C.V.
Veracruz, 91910
Czechia4 sites
University Hospital Ostrava
Ostrava, 708 00
Fakultni Nemocnice Plzen
Plzen-Bory, 30100
Univ. Hospital Kralovske Vinohrady
Prague, 100 34
University Hospital Bulovka
Prague, 18081
Italy4 sites
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Pol. Universitario Tor Vergata
Roma, 00133
Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
Roma, 00167
Philippines4 sites
Southern Philippines Medical Center -Davao-62091
Davao City, 8000
Center for Skin Research, Testing and Product Development
Makati City, 1200
Philippine General Hospital
Manila, Philippines, 1000
East Avenue Medical Center
Quezon City, 1100
Australia3 sites
Alfred Hospital
Melbourne, Victoria, 3004
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Westmead Hospital
Westmead, New South Wales, 2145
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
Bispebjerg og Frederiksberg Hospital
København NV, 2400
Sjællands Universitetshospital
Roskilde, 4000
South Korea3 sites
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Switzerland3 sites
Universitätsspital Basel
Basel, 4055
University Hospital Bern/Inselspital Bern
Bern, 3010
Hôpitaux Universitaires Genève (HUG)
Geneva, 1205
Turkey (Türkiye)3 sites
SBU Gulhane Training and Research Hospital
Ankara, 06011
Akdeniz University Medical Faculty
Antalya, 7070
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55270
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Centre Hospitalier Universitaire de Liège
Liège, 4000
Chile2 sites
Centro Internacional de Estudios Clínicos (CIEC)
Comuna de Recoleta, 8420383
Clínica Dermacross S.A.
Vitacura, 7640881
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161
Vilnius University Hospital, Santariskiu
Vilnius, 08411
Slovakia2 sites
DOST sro - Sanatorium-Type Dermatovenereological Department
Svidník, 089 01
FN Trnava
Trnava, 91702
United Kingdom2 sites
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
St George's Hospital-London-26733
London, SW17 0QT
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
Singapore1 site
National University Hospital-Singapore-42005
Singapore, 119074
Vietnam1 site
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City, 70000
About this study
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.
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.
Read more
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.
Read the detailed description
Main endpoints for Part 2 will be supported by Part 1 results available at time of primary analysis.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Spesolimab i.v., Spesolimab s.c., Placebo matching Spesolimab i.v., Placebo matching Spesolimab s.c.
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spesolimab i.v.Drug
Also called Spevigo®
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab s.c.Drug
Also called Spevigo®
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.
Placebo matching Spesolimab i.v.Drug
Weekly dose of placebo via i.v. for 4 weeks.
Placebo matching Spesolimab s.c.Drug
Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab low dose group | Experimental | 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. Receives: Drug: Spesolimab i.v.; Drug: Spesolimab s.c. |
| Spesolimab medium dose group | Experimental | 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). Receives: Drug: Spesolimab i.v.; Drug: Spesolimab s.c. |
| Spesolimab high dose group | Experimental | 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). Receives: Drug: Spesolimab i.v.; Drug: Spesolimab s.c. |
| Placebo | Placebo comparator | 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). Receives: Drug: Spesolimab s.c.; Drug: Placebo matching Spesolimab i.v.; Drug: Placebo matching Spesolimab s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 Apr 2023
- Primary completion1 Aug 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819398
- Sponsor's protocol ID
- 1368-0098
- Other IDs
- 2022-501074-19-00
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2023
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05819398
- Acronym / sponsor ID
- 1368-0098
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spesolimab low dose group | Experimental | Drug: Spesolimab i.v., Drug: Spesolimab s.c.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. |
| Spesolimab medium dose group | Experimental | Drug: Spesolimab i.v., Drug: Spesolimab s.c.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). |
| Spesolimab high dose group | Experimental | Drug: Spesolimab i.v., Drug: Spesolimab s.c.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). |
| Placebo | Placebo comparator | Drug: Spesolimab s.c., Drug: Placebo matching Spesolimab i.v., Drug: Placebo matching Spesolimab s.c.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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/immunomodulatory 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spesolimab i.v.Also: Spevigo®Weekly dose of spesolimab via i.v. for 4 weeks. | Drug | Spesolimab high dose group, Spesolimab low dose group, Spesolimab medium dose group |
| Spesolimab s.c.Also: Spevigo®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. | Drug | Placebo, Spesolimab high dose group, Spesolimab low dose group, Spesolimab medium dose group |
| Placebo matching Spesolimab i.v.Weekly dose of placebo via i.v. for 4 weeks. | Drug | Placebo |
| Placebo matching Spesolimab s.c.Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks. | Drug | Placebo |
Primary outcome
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8
Time frame: 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.
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.
4 secondary outcomes
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
162 sites in 35 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Spesolimab i.v. and Spesolimab s.c. in people with Hidradenitis Suppurativa, run by Boehringer Ingelheim at 162 sites in 35 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 162 sites in United States, Japan, Spain, China, Malaysia and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.