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Study to Evaluate the Effectiveness of Spesolimab for Patients with Moderate to Severe Hidradenitis Suppurativa

4 1

What is this study about?

This clinical trial is focused on studying a skin condition called hidradenitis suppurativa, which is characterized by painful lumps under the skin, often in areas like the armpits or groin. The study is testing a treatment called spesolimab, which is a type of medication known as a humanized monoclonal antibody. This medication is being tested in two forms: a solution for infusion and a solution for injection in a pre-filled syringe. The purpose of the study is to evaluate how effective and safe spesolimab is for people with moderate to severe hidradenitis suppurativa.

The study is divided into two parts. The first part aims to find the best dose of spesolimab for treating moderate to severe hidradenitis suppurativa. The second part will confirm how well the treatment works and how safe it is for patients. Participants in the study may receive either spesolimab or a placebo, which is a substance with no active medication. The study will monitor changes in the condition of the skin over time to assess the treatment’s effectiveness.

Participants will receive the treatment over a period of time, with regular check-ups to monitor their progress and any side effects. The study is designed to ensure that the treatment is both effective and safe for those with hidradenitis suppurativa. The results of this study could provide valuable information about a new potential treatment option for this challenging skin condition.

1 joining the study

Upon joining the study, you will be required to provide a signed and dated written informed consent. This is to ensure that you understand the study and agree to participate.

You must be of full age of consent and have moderate to severe hidradenitis suppurativa, with lesions in at least two distinct anatomic areas.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your medical history and current health status.

You must have a total AN count of greater than or equal to 5 and a total dT count of at least 1 at the baseline visit.

3 treatment phase

The treatment phase consists of two parts: Phase IIb and Phase III. The purpose is to find the optimal dose and assess the efficacy and safety of spesolimab.

You may receive spesolimab or a placebo. The medication is administered as a solution for infusion or injection in a pre-filled syringe.

4 medication administration

During the trial, you will receive the medication at specified intervals. The exact dosage and frequency will be determined by the study protocol.

The duration of administration will be communicated to you by the study team.

5 monitoring and follow-up

Regular monitoring will be conducted to assess your response to the treatment and any side effects.

You will be required to attend follow-up visits as scheduled by the study team.

6 completion of the study

Upon completion of the study, a final assessment will be conducted to evaluate the overall outcomes.

You will be informed about the results and any further steps, if necessary.

Who Can Join the Study?

  • You must be of full age of consent at the time of screening.
  • You need to provide a signed and dated written informed consent, which means you agree to participate in the study after understanding all the details.
  • You must have moderate to severe Hidradenitis suppurativa (HS).
  • You should have HS lesions in at least two different areas of your body.
  • You can participate if you have never used biologic treatments for HS or if you have used TNFi (a type of biologic treatment) before.
  • If you have never used biologic treatments, you must have tried an adequate course of oral antibiotics for HS and found them not effective enough. All participants must have used antibiotics for HS before.
  • You need to have a total AN count (a way to measure the severity of HS) of 5 or more.
  • You must have a total dT count (another measure related to HS) of at least 1 at the start of the study.
  • Additional criteria may apply.

Who Cannot Join the Study?

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients with certain infections that are not well controlled.
  • Patients who have had a major surgery recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are taking medications that might interfere with the study.
  • Patients with certain immune system disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Universitario De Salamanca Salamanca Spain
Bispebjerg Hospital Copenhagen Denmark
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Royalderm Agnieszka Nawrocka Warsaw Poland
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Klinik Hietzing Vienna Austria
Hospices Civils De Lyon Lyon France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Prive D Antony Antony France
Helse Stavanger HF Stavanger Norway
Hospital Cuf Descobertas S.A. Lisbon Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Region Midtjylland Aarhus Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Fondazione Luigi Maria Monti Rome Italy
Charite Research Organisation GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Katholisches Klinikum Bochum gGmbH Bochum Germany
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Fakultni Nemocnice Bulovka Prague Czechia
Fakultna Nemocnica Trnava Trnava Slovakia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Hms GmbH Merzig Germany
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Hospital General De Granollers Granollers Spain
Termedia Sp. z o.o. Poznan Poland
University Hospital Ostrava Ostrava Czechia
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Hôpital Pontchaillou-CHU Rennes Rennes France
Zealand University Hospital Koege Denmark
Fakultni Nemocnice Plzen Plzen Czechia
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
DOST (dermatovenerologicke oddelenie sanatorneho typu) Svidnik Slovakia
Suomen Terveystalo Oy Tampere Finland
Anbsdtlqid Pxtkhslr Hiecfbac Dx Pubpk Paris France
Pclucbzlh Iawouuhd Mncrfwpx Meqousfeasij Svhmv Wmtolwvbzepv I Ajkruetikifbf Warsaw Poland
Puulzcq Pkqnqnlunlp Warsaw Poland
Nvziwpxzhg Hehwhn Cuuj Fikxdwfz Lxxxtiy Ossy Poland
Uxoballhyctgxdrck Dfmzb Sjsbs Dl Rjzr Lq Sapcomqx Terracina Italy
Cjhswoaun Upblfmndssobdu Saswzfjhf Woluwe-Saint-Lambert Belgium
Atkgdztpja Pfemhwce Htbapzuo Dw Mmhvkhant Marseille France
Ajzanox Oetujzcemkn Uhmwwgznevpht Cbdecctsyolx Djyvl Sukcut E Dttes Smayrqb Dj Toxulh Turin Italy
Mtxooriz Mcgdtjc Aseonyh Pleven Bulgaria
Hoxrtkvm Dt Ls Sbfdj Chhq I Shah Pob Barcelona Spain
Izqgzb Ithzsgem Fmhekrtmpbsdx Ohkaltllccr Rome Italy
Uqwiccjxumxk Mhdoucn Cyjluxo Ggiqzjbuk Groningen The Netherlands
Tmncfgixicg uhi Sjlivbwbtbb Bwmvuelu Gyoz Bad Bentheim Germany
Mfhuglj Cqwvfo Kcmezl Ogh Pleven Bulgaria
Ugjzeucucb Gcvlylt Hhvpeuwd Akujqeo Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.05.2023
Belgium Belgium
Not recruiting
22.05.2023
Bulgaria Bulgaria
Not recruiting
22.05.2023
Czechia Czechia
Not recruiting
22.05.2023
Denmark Denmark
Not recruiting
22.05.2023
Finland Finland
Not recruiting
22.05.2023
France France
Not recruiting
22.05.2023
Germany Germany
Not recruiting
22.05.2023
Greece Greece
Not recruiting
22.05.2023
Italy Italy
Not recruiting
22.05.2023
Lithuania Lithuania
Not recruiting
22.05.2023
Norway Norway
Not recruiting
22.05.2023
Poland Poland
Not recruiting
22.05.2023
Portugal Portugal
Not recruiting
22.05.2023
Slovakia Slovakia
Not recruiting
22.05.2023
Spain Spain
Not recruiting
22.05.2023
The Netherlands The Netherlands
Not recruiting
22.05.2023

Trial locations

Investigated drugs:

Spesolimab is a medication being studied for its potential to help people with a skin condition called hidradenitis suppurativa, which causes painful lumps under the skin. This medication works by targeting specific parts of the immune system that are thought to play a role in causing the inflammation and symptoms of this condition. The goal of using spesolimab in this trial is to see if it can reduce the severity of the symptoms and improve the quality of life for patients with moderate to severe forms of this condition.

Hidradenitis suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause of hidradenitis suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.

Trial ID:
2022-501074-19-00
Protocol code:
1368-0098
Trial Phase:
Therapeutic use (Phase IV)

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