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

April 15, 2024 updated by: Boehringer Ingelheim

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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, C1023AAB
      • Caba, Argentina, C1056AB
      • Capital Federal, Argentina, C1118AAT
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata
        • Contact:
      • Rosario, Argentina, 2000
        • Recruiting
        • Instituto de Especialidades de la Salud Rosario
        • Contact:
      • San Miguel de Tucumán, Argentina, 4000
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Austria
      • Vienna, Austria, 1090
  • Belgium
      • Bruxelles, Belgium, 1200
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liège
        • Contact:
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1407
      • Sofia, Bulgaria, 1463
      • Stara Zagora, Bulgaria, 6000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C3
        • Recruiting
        • Alberta Dermasurgery Centre
        • Contact:
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • SimcoDerm Medical and Surgical Dermatology Centre
        • Contact:
      • Guelph, Ontario, Canada, N1L 0B7
        • Recruiting
        • Guelph Dermatology Research
        • Contact:
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Recruiting
        • Dr. S. K. Siddha Medicine Professional Corporation
        • Contact:
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Recruiting
        • York Dermatology Clinic and Research Centre
        • Contact:
  • Chile
      • Comuna De Recoleta, Chile, 8420383
        • Recruiting
        • Centro Internacional de Estudios Clinicos (CIEC)
        • Contact:
      • Vitacura, Chile, 7640881
        • Recruiting
        • Clinica Dermacross S.A.
        • Contact:
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Chengdu, China, 610041
      • Guangzhou, China, 510091
        • Recruiting
        • Southern Medical University Dermatology Hospital
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Shanghai, China, 200000
        • Recruiting
        • Shanghai Skin Disease Hospital
        • Contact:
      • Urumqi, China, 830001
        • Recruiting
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
  • Czechia
      • Prague, Czechia, 18081
        • Recruiting
        • University Hospital Bulovka
        • Contact:
  • Denmark
      • København NV, Denmark, 2400
        • Recruiting
        • Bispebjerg og Frederiksberg Hospital
        • Contact:
      • Roskilde, Denmark, 4000
        • Recruiting
        • Sjællands Universitetshospital
        • Contact:
  • Finland
      • Tampere, Finland, 33100
        • Recruiting
        • Suomen Terveystalo oy Tampere
        • Contact:
  • France
      • Antony, France, 92160
      • Lyon, France, 69437
      • Marseille, France, 13385
      • Nice, France, 06200
      • Paris, France, 75010
      • Poitiers, France, 86000
      • Rennes, France, 35033
  • Germany
      • Bad Bentheim, Germany, 48455
      • Berlin, Germany, 10117
      • Bochum, Germany, 44791
      • Göttingen, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen, Georg-August-Universität
        • Contact:
      • Merzig, Germany, 66663
      • Oldenburg, Germany, 26133
  • Greece
      • Athens, Greece, 124 62
        • Recruiting
        • University General Hospital Attikon
        • Contact:
      • Athens, Greece, 16121
        • Recruiting
        • Andreas Syggros Hospital of Cutaneous & Venereal Diseases
        • Contact:
      • Thessaloniki, Greece, 56403
        • Recruiting
        • General Hospital "G. Papageorgiou"
        • Contact:
      • Thessaloniki, Greece, 54643
        • Recruiting
        • General Hospital of Thessaloniki "Ippokrateio"
        • Contact:
  • Israel
      • Afula, Israel, 1834111
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
      • Petach Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center Beilinson
        • Contact:
      • Ramat Gan, Israel, 52621
      • Tel Aviv, Israel, 64239
  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Napoli, Italy, 80131
      • Napoli, Italy, 80131
        • Recruiting
        • AOU Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
      • Roma, Italy, 00133
        • Recruiting
        • Pol. Universitario Tor Vergata
        • Contact:
      • Roma, Italy, 00167
        • Recruiting
        • Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
        • Contact:
      • Rozzano (MI), Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Recruiting
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Aichi, Nagoya, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
      • Aichi, Toyoake, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Contact:
      • Fukuoka, Kurume, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
      • Gifu, Ogaki, Japan, 503-8502
        • Recruiting
        • Ogaki Municipal Hospital
        • Contact:
      • Hyogo, Nishinomiya, Japan, 663-8186
      • Ibaraki, Tsukuba, Japan, 305-8576
        • Recruiting
        • University of Tsukuba Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Okayama, Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
      • Okayama, Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Organization Okayama Medical Center
        • Contact:
      • Okinawa, Nakagami-gun, Japan, 903-0215
        • Recruiting
        • University of the Ryukyus Hospital
        • Contact:
      • Osaka, Hirakata, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Contact:
      • Shiga, Otsu, Japan, 520-2192
        • Recruiting
        • Shiga University Of Medical Science Hospital
        • Contact:
      • Tochigi, Shimotsuga-gun, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8655
        • Recruiting
        • The University of Tokyo Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07441
        • Recruiting
        • Hallym University Kangnam Sacred Heart Hospital
        • Contact:
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Contact:
      • Vilnius, Lithuania, 08411
        • Recruiting
        • Vilnius University Hospital, Santariskiu
        • Contact:
  • Malaysia
      • Georgetown Pulau Pinang, Malaysia, 10990
      • Johor Bahru, Malaysia, 81100
      • Johor Bahru, Malaysia, 80100
      • Kota Bahru, Malaysia, 15586
        • Recruiting
        • Hospital Raja Perempuan Zainab II, Kota Bharu
        • Contact:
      • Kuala Lumpur, Malaysia, 50586
      • Kuala Trengganu, Malaysia, 20400
      • Kuching, Malaysia, 93586
      • Selangor Darul Ehsan, Malaysia, 47500
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Recruiting
        • Derma Norte del Bajio S.C.
        • Contact:
      • Guadalajara, Mexico, 44638
        • Recruiting
        • Grupo Clinico CATEI S.C.
        • Contact:
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • Monterrey, Mexico, 64718
      • Veracruz, Mexico, 91910
        • Recruiting
        • Arke Estudios Clinicos Sa De Cv
        • Contact:
  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
  • New Zealand
      • Hamilton, New Zealand, 3204
  • Philippines
      • Davao City, Philippines, 8000
        • Recruiting
        • Southern Philippines Medical Center
        • Contact:
      • Makati City, Philippines, 1200
        • Recruiting
        • Center for Skin Research, Testing and Product Development
        • Contact:
      • Manila, Philippines, Philippines, 1000
      • Quezon City, Philippines, 1100
  • Poland
      • Ossy, Poland, 42624
        • Recruiting
        • Non-Public Health Care Facility LABDERM
        • Contact:
      • Poznan, Poland, 60-681
        • Recruiting
        • NSZOZ Termedica Clinical Research Center
        • Contact:
      • Rzeszow, Poland, 35055
        • Recruiting
        • Frederic Chopin University Hospital No. 1 in Rzeszow
        • Contact:
      • Warsaw, Poland, 02-507
        • Recruiting
        • National Medical Institute MSWiA
        • Contact:
      • Warsaw, Poland, 01-817
        • Recruiting
        • High-Med Specialist Clinic, Warsaw
        • Contact:
      • Warsaw, Poland, 02-647
      • Warszawa, Poland, 02-962
      • Wroclaw, Poland, 51-685
        • Recruiting
        • Centrum Zdrowia WroMedica
        • Contact:
  • Singapore
      • Singapore, Singapore, 119074
  • Slovakia
      • Svidnik, Slovakia, 089 01
        • Recruiting
        • DOST sro - Sanatorium-Type Dermatovenereological Department
        • Contact:
      • Trnava, Slovakia, 91702
  • South Africa
      • Cape Town, South Africa, 7530
  • Spain
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario San Cecilio
        • Contact:
      • Granollers, Spain, 08402
        • Recruiting
        • Hospital General de Granollers
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 De Octubre
        • Contact:
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
      • Manises, Spain, 46940
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Complexo Hospitalario Universitario De Santiago
        • Contact:
      • Zaragoza, Spain, 50009
  • Switzerland
      • Basel, Switzerland, 4055
        • Recruiting
        • University Hospital Basel
        • Contact:
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital Bern/Inselspital Bern
        • Contact:
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie
        • Contact:
  • United Kingdom
      • Gloucester, United Kingdom, GL1 3NN
      • London, United Kingdom, SW17 0QT
  • United States
    • California
      • Fountain Valley, California, United States, 92708
      • Los Angeles, California, United States, 90045
      • Sacramento, California, United States, 95815
      • Thousand Oaks, California, United States, 91320
    • Florida
      • North Miami Beach, Florida, United States, 33162
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33615
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Suspended
        • Skin Sciences, PLLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Auburn Hills, Michigan, United States, 48326
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Suspended
        • AXIS Clinicals
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Greenville, South Carolina, United States, 29615
    • Texas
      • Houston, Texas, United States, 77004
      • San Antonio, Texas, United States, 78213
  • Vietnam
      • Ho Chi Minh, Vietnam, 70000
        • Recruiting
        • HCMC Hospital of Dermato-Venereology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part I: Low dose group
Drug: Spesolimab Formulation 1
Spesolimab Formulation 1
Other Names:
  • Spevigo®
Drug: Spesolimab Formulation 2
Spesolimab Formulation 2
Other Names:
  • Spevigo®
Experimental: Part I: Medium dose group
Drug: Spesolimab Formulation 1
Spesolimab Formulation 1
Other Names:
  • Spevigo®
Drug: Spesolimab Formulation 2
Spesolimab Formulation 2
Other Names:
  • Spevigo®
Experimental: Part I: High dose group
Drug: Spesolimab Formulation 1
Spesolimab Formulation 1
Other Names:
  • Spevigo®
Drug: Spesolimab Formulation 2
Spesolimab Formulation 2
Other Names:
  • Spevigo®
Placebo Comparator: Part I: Placebo group
Drug: Placebo matching Spesolimab Formulation 1
Placebo matching Spesolimab Formulation 1
Drug: Placebo matching Spesolimab Formulation 2
Placebo matching Spesolimab Formulation 2
Experimental: Part II: Active (treatment) group
Drug: Spesolimab Formulation 2
Spesolimab Formulation 2
Other Names:
  • Spevigo®
Placebo Comparator: Part II: Placebo group
Drug: Placebo matching Spesolimab Formulation 2
Placebo matching Spesolimab Formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Percent change from baseline in Draining fistula/tunnel (dT) count at Week 8
Time Frame: At baseline and at week 8
At baseline and at week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Percent change from baseline in dT count at Week 16 (part 1)
Time Frame: At baseline and at week 16
At baseline and at week 16
Part 1: Absolute change from baseline in International hidradenitis suppurativa severity score system (IHS4) value at Week 8
Time Frame: At baseline and 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
Part 1: Absolute change from baseline in IHS4 value at Week 16
Time Frame: At baseline and at week 16
At baseline and at week 16
Part 1: Occurrence of treatment emergent adverse events (TEAEs)
Time Frame: up to 64 weeks
up to 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

July 29, 2024

Study Completion (Estimated)

August 17, 2028

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 (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms o

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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