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New drug spesolimab shows promise for painful skin condition

NCT ID NCT05819398

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether spesolimab, a drug already approved for another skin condition, can help people with moderate to severe hidradenitis suppurativa (HS), a painful skin disease that causes abscesses and tunnels. 209 adults participated, receiving either spesolimab or a placebo through injections. The trial aimed to see if the drug reduces draining tunnels and improves symptoms over several months. Results will show if spesolimab is a safe and effective new option for HS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spesolimab (Spevigo®)
What this could lead to
If successful, spesolimab could offer a new treatment option for people with moderate to severe hidradenitis suppurativa who haven't responded to other therapies.
What could go wrong
This is a mid-stage trial with only 209 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

209 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • AKH - Medical University of Vienna

    Vienna, 1090, Austria

  • AOU Università degli Studi della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • ASMC-IPSMC-skin and Veneral Diseases

    Sofia, 1407, Bulgaria

  • AXIS Clinicals

    Fargo, North Dakota, 58103, United States

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Akdeniz University Medical Faculty

    Antalya, 7070, Turkey (Türkiye)

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3, Canada

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Andreas Syggros Hospital of Cutaneous & Venereal Diseases

    Athens, 16121, Greece

  • Arke SMO S.A. de C.V.

    Veracruz, 91910, Mexico

  • Attikon University Hospital

    Athens, 12462, Greece

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • Bispebjerg og Frederiksberg Hospital

    København NV, 2400, Denmark

  • Center for Clinical Studies-Houston-58806

    Houston, Texas, 77004, United States

  • Center for Skin Research, Testing and Product Development

    Makati City, 1200, Philippines

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Centro Internacional de Estudios Clínicos (CIEC)

    Comuna de Recoleta, 8420383, Chile

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, 7600, Argentina

  • Centrum Zdrowia WroMedica

    Wroclaw, 51-685, Poland

  • Chang Gung Memorial Hospital Linkou

    Taoyuan, 333, Taiwan

  • Charite Universitätsmedizin Berlin KöR

    Berlin, 10117, Germany

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica Dermacross S.A.

    Vitacura, 7640881, Chile

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, 15706, Spain

  • DCC "Fokus-5-LZIP" OOD

    Sofia, 1463, Bulgaria

  • DOST sro - Sanatorium-Type Dermatovenereological Department

    Svidník, 089 01, Slovakia

  • Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995

    Indianapolis, Indiana, 46250, United States

  • Derma Norte del Bajio S.C.

    Aguascalientes, 20127, Mexico

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Diagnostic Consultative Center Alexandrovska

    Sofia, 1431, Bulgaria

  • Dokkyo Medical University Hospital

    Tochigi, Shimotsuga-gun, 321-0293, Japan

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario, L3Y 5G8, Canada

  • East Avenue Medical Center

    Quezon City, 1100, Philippines

  • Eukarya Pharmasite

    Monterrey, 64718, Mexico

  • FN Trnava

    Trnava, 91702, Slovakia

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • Fakultni Nemocnice Plzen

    Plzen-Bory, 30100, Czechia

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • ForCare Clinical Research, Inc.

    Tampa, Florida, 33613, United States

  • Frederic Chopin University Hospital No. 1 in Rzeszow

    Rzeszów, 35055, Poland

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192, Japan

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56403, Greece

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54643, Greece

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN, United Kingdom

  • Grupo Clinico CATEI S.C.

    Guadalajara, 44638, Mexico

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B7, Canada

  • HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092

    Ho Chi Minh City, 70000, Vietnam

  • HOP Edouard Herriot

    Lyon, 69437, France

  • HOP Pontchaillou

    Rennes, 35033, France

  • HOP Privé Antony

    Antony, 92160, France

  • HOP Saint-Louis

    Paris, 75010, France

  • HOP Timone

    Marseille, 13385, France

  • HOP l'Archet

    Nice, 06200, France

  • HOP la Milétrie

    Poitiers, 86000, France

  • Haemek Medical Center

    Afula, 1834111, Israel

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441, South Korea

  • Hautmedizin Saar

    Merzig, 66663, Germany

  • High-Med Specialist Clinic, Warsaw

    Warsaw, 01-817, Poland

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010, Australia

  • Hospital Alemán

    Capital Federal, C1118AAT, Argentina

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital General de Granollers

    Granollers, 08402, Spain

  • Hospital Italiano de Buenos Aires

    CABA, C1056AB, Argentina

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Pulau Pinang-Pulau Pinang-21953

    Georgetown Pulau Pinang, 10990, Malaysia

  • Hospital Raja Perempuan Zainab II, Kota Bharu

    Kota Bharu, 15586, Malaysia

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, 80100, Malaysia

  • Hospital Sultanah Nur Zahirah

    Kuala Terengganu, 20400, Malaysia

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Hospital Universitario Reina Sofía-Córdoba-40500

    Córdoba, 14004, Spain

  • Hospital Universitario San Cecilio

    Granada, 18012, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de Manises

    Manises, 46940, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161, Lithuania

  • Hôpitaux Universitaires Genève (HUG)

    Geneva, 1205, Switzerland

  • Instituto de Especialidades de la Salud Rosario

    Rosario, 2000, Argentina

  • Integrative Skin Science and Research-Sacramento-69402

    Sacramento, California, 95815, United States

  • Istituto Dermopatico Dell'Immacolata - IDI - IRCCS

    Roma, 00167, Italy

  • Japan Community Healthcare Organization Chukyo Hospital

    Aichi, Nagoya, 457-8510, Japan

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191, Japan

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Klinikum Oldenburg AöR

    Oldenburg, 26133, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011, Japan

  • MHAT Prof Stoyan Kirkovich AD

    Stara Zagora, 6000, Bulgaria

  • Medical Center "Kordis"

    Pleven, 5800, Bulgaria

  • Medical Military Academy MHAT Sofia

    Sofia, 1606, Bulgaria

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meiwa Hospital

    Hyogo, Nishinomiya, 663-8186, Japan

  • NSZOZ Termedica Clinical Research Center

    Poznan, 60-681, Poland

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama, 701-1192, Japan

  • National Medical Institute MSWiA

    Warsaw, 02-507, Poland

  • National University Hospital-Singapore-42005

    Singapore, 119074, Singapore

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610, Japan

  • Non-Public Health Care Facility LABDERM

    Ossy, 42624, Poland

  • Oakland Hills Dermatology, PC

    Auburn Hills, Michigan, 48326, United States

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502, Japan

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Olympian Clinical Research-Tampa-69560

    Tampa, Florida, 33615, United States

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55270, Turkey (Türkiye)

  • Palmetto Clinical Trial Services

    Greenville, South Carolina, 29615, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Philippine General Hospital

    Manila, Philippines, 1000, Philippines

  • Pol. Universitario Tor Vergata

    Roma, 00133, Italy

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Provita Clinic

    Warsaw, 02-647, Poland

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Royalderm

    Warsaw, 02-962, Poland

  • SBU Gulhane Training and Research Hospital

    Ankara, 06011, Turkey (Türkiye)

  • STAT Research

    CABA, C1023AAB, Argentina

  • Sanatorio 9 de Julio S.A.

    San Miguel de Tucumán, 4000, Argentina

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, 200000, China

  • Sheba MC

    Ramat Gan, 52621, Israel

  • Shiga University of Medical Science Hospital

    Shiga, Otsu, 520-2192, Japan

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Sjællands Universitetshospital

    Roskilde, 4000, Denmark

  • Skin Sciences, PLLC

    Louisville, Kentucky, 40217, United States

  • Skin Specialists, P.C.

    Omaha, Nebraska, 68144, United States

  • Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Southern Medical University Dermatology Hospital

    Guangzhou, 510091, China

  • Southern Philippines Medical Center -Davao-62091

    Davao City, 8000, Philippines

  • St George's Hospital-London-26733

    London, SW17 0QT, United Kingdom

  • Sunway Medical Centre

    Selangor Darul Ehsan, 47500, Malaysia

  • Suomen Terveystalo oy Tampere

    Tampere, 33100, Finland

  • TASK Applied Science

    Cape Town, 7530, South Africa

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • The University of Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8655, Japan

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB, Netherlands

  • University General Hospital Attikon

    Athens, 124 62, Greece

  • University Hospital Bern/Inselspital Bern

    Bern, 3010, Switzerland

  • University Hospital Bulovka

    Prague, 18081, Czechia

  • University Hospital Ostrava

    Ostrava, 708 00, Czechia

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Tsukuba Hospital

    Ibaraki, Tsukuba, 305-8576, Japan

  • University of the Ryukyus Hospital

    Okinawa, Ginowan, 901-2725, Japan

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075, Germany

  • Universitätsspital Basel

    Basel, 4055, Switzerland

  • Vilnius University Hospital, Santariskiu

    Vilnius, 08411, Lithuania

  • Waikato Hospital

    Hamilton, 3204, New Zealand

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, 830001, China

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4B 1L1, Canada

  • Ziaderm Research

    North Miami Beach, Florida, 33162, United States

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