Study on Long-Term Use of Spesolimab for Patients with Hidradenitis Suppurativa Who Completed a Previous Spesolimab Study

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What is this study about?

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa (HS). HS is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The trial involves a treatment called Spesolimab, which is a solution for injection. Spesolimab is a type of medication known as a humanized monoclonal antibody, which is designed to target specific proteins in the body that may be involved in causing inflammation.

The purpose of this study is to assess the long-term safety of Spesolimab in people with HS who have already participated in a previous study with this medication. Participants in this trial will receive Spesolimab or a placebo, which is a substance with no active medication, to compare the effects. The study will monitor participants over a period to observe any side effects or changes in their condition.

Throughout the study, participants will receive regular injections of Spesolimab and will be closely monitored by healthcare professionals. The trial aims to provide valuable information on how safe and effective Spesolimab is for long-term use in treating HS. This information could help improve treatment options for people living with this challenging skin condition.

1 joining the trial

Upon joining the trial, ensure that a signed and dated written informed consent is provided. This is in accordance with guidelines for good clinical practice and local legislation.

Confirm that participation is within the defined residual effect period, which is 16 weeks since the last administration of spesolimab.

2 eligibility confirmation

Verify completion of treatment in the previous spesolimab trial (1368-0098) without premature discontinuation.

Confirm willingness and ability to continue treatment in this trial.

3 treatment administration

Receive spesolimab as a solution for injection in a pre-filled syringe. The administration is subcutaneous, meaning it is injected under the skin.

The trial aims to assess the long-term safety of spesolimab in participants with hidradenitis suppurativa (HS).

4 monitoring and assessment

The primary focus is on monitoring the occurrence of treatment emergent adverse events (TEAE).

Regular assessments will be conducted to ensure safety and effectiveness of the treatment.

5 trial duration

The estimated end date for the trial is April 17, 2030.

The recruitment for the trial is expected to start on May 6, 2024.

Who Can Join the Study?

  • You must have signed and dated a written informed consent form. This means you agree to participate in the study and understand what it involves.
  • You should be within the Residual Effect Period, which is 16 weeks since your last dose of the study medication called spesolimab.
  • You must have completed treatment in the previous study with spesolimab for Hidradenitis Suppurativa (HS), without stopping early, and be willing to continue treatment in this new study.
  • If you are a woman who can have children, you must be ready and able to use very effective birth control methods. These methods should have a very low chance of failing, less than 1% per year, if used correctly and consistently.

Who Cannot Join the Study?

  • Participants who have not completed approximately 8 to 12 months of treatment with the study medication, spesolimab, in the earlier parts of the trial.
  • Participants who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Participants who are currently taking other medications that might interfere with the study medication.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of severe allergic reactions to medications similar to spesolimab.
  • Participants who have any other skin conditions that might interfere with the study results.
  • Participants who have a history of drug or alcohol abuse that might affect their ability to follow the study procedures.
  • Participants who have participated in another clinical trial within a certain period before this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Klinik Hietzing Vienna Austria
Katholisches Klinikum Bochum gGmbH Bochum Germany
Fakultni Nemocnice Bulovka Prague Czechia
Hms GmbH Merzig Germany
Suomen Terveystalo Oy Tampere Finland
Clikejech Ufagkmxzgwrecl Skybtvrhq Woluwe-Saint-Lambert Belgium
Dywogzmurwldzlqtatnqrqd cvworh “oinbhvydyvsmjku Ekgp Sofia Bulgaria
Rvuwyw Suzdaheuh Holbæk Denmark
Flbneonrva Ilmew Cm Gziebp Oxnsfvec Mdqgxhnr Pwwblnkrwdt Milan Italy
Aydrqsoaak Pjzkhabc Htlolzug Du Mujqhcckk Marseille France
Vpebkysu uavrphqcztkl llvddivw Sweoagcz kcgcndwd Vwz Vilnius Lithuania
Fpxwwtjg Nfbsyilqb Kznktyhss Vyxssahnd Prague Czechia
Utoxvkjbqciezehip Pimjvpdltje Dpvre Mscejp Ancona Italy
Uvswkxtajkcw Dp Srmbscju Du Csfxtdqyza Santiago De Compostela Spain
Awawepz Ofpkyihxhpr Uafztwzeuilkn Ckdxlaqqsvpk Dbtzp Syzgjo E Diiil Scexvdx Dl Tjljwb Turin Italy
Axpjesx Ovapbwdydhj Ulajxttqyepur Fhyfvxge Io Dq Nxehdb Naples Italy
Regopx Mkuovgczxfg Aarhus Denmark
Hmououb Puwug D Afotzh Antony France
Cjfwgg Honnrrmvjem Upedsjyuzqmvs Da Rrxgjn Rennes France
Hmjshsoz Db Lt Sthde Cozs I Spyl Pub Barcelona Spain
Isrwxh Ihflffsq Fesgcljhpezcw Ollrjdinujo Rome Italy
Usejmhvfns Dwwgc Saskp Dv Rcth Lo Sqjaezim Rome Italy
Cdegxk hnydbxhsaym uimiztcjrwrzm dg Lkatt Liege Belgium
Ceaznd Hdcbuocdhlk Lodw Ski Pierre Benite France
Htyvibug Umetqvtxfxrss 1h Dt Otpvxzc Madrid Spain
Fhypfxdl Ncqbakddb Tktnhd Trnava Slovakia
Iehikansyc Gzkhpqg Hppxxave Oj Tponxfytkjpp Thessaloniki Greece
Mlpajkg Cjgbgw Kvhvbk Ovz Pleven Bulgaria
Umahvelsav Gpantwh Hvhsdcbn Aehdisx Athens Greece
Kdurydfw Otzrbjcvk Avy Oldenburg In Holstein Germany
Fjezgbqd Ndajuqhhv Pjurr Plzen Czechia
Acnyzwz Oxefuiwgzopuvsomfikwvrhph Pdcxivwpsyo Ga Rjfcwtmqcctq Myhru De Cyvpkxt Catania Italy
Umaydniodzoff Sikvfuz Kupovvrno Ihdnmbhmgiaw Ctshzup W Rzkzgvrhw Rzeszow Poland
Noupbsyieq Hqbgje Cgim Fuisbfcf Lyelkqs Ossy Poland
Puhuict Pppppxijztw Sku z ojnc Warsaw Poland
Gnbvtmt Hfthbwml On Tofsaudipclu Plzldqibbqnx Thessaloniki Greece
Anaj – Idgqa &hksbpx Shyc Awu Vvkqjszq Dsmflito Sofia Bulgaria
Ubjnddwtkspkbnlgo Dr Pxdw Pisa Italy
Azcymfo Symkwkp Hyahqyht Ov Veprcgrn Abp Dgfacfoqzkujzc Drblmbft Athens Greece
Pbwllntrh Ibrpvvmu Molupfqh Mhwnrtgrpera Svlpo Wpqpulnowurq I Afmdxctufxnne Warsaw Poland
Mjksshkv Mpplioi Aimggac Pleven Bulgaria
Cjdqjc Hhftszbizcl Ufqszcolvqijq Dz Pibxychr Poitiers France
Fuoygwrptc Ldjbg Mkmqx Mfean Rome Italy
Lnlrxluq syuvnrgef mheush uvvnpcqvqqaq lgzbqyws Ktnkh ksroeyrn Kaunas Lithuania
Wkjjpfimf I Bewmzbhd A Svpsmhcevzzy scxd Wroclaw Poland
Tappmfsbohy uml Sindnyewqjw Bdavycip Gvdr Bad Bentheim Germany
Ucwip &fknusv Prkag Drb Sfemgk Kvkiouroh Aj Stara Zagora Bulgaria
Hmiklfow Gwtcjxe Db Givzborurv Granollers Spain
Tgrdcnha Sth z owrq Poznan Poland
Dqxukj Bvjbvsgkevclf Hlszc Mad Pusxwdqosof Safyofjtxdvhxeb Warsaw Poland

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
06.05.2024
Belgium Belgium
Not recruiting
06.05.2024
Bulgaria Bulgaria
Not recruiting
06.05.2024
Czechia Czechia
Not recruiting
06.05.2024
Denmark Denmark
Not recruiting
06.05.2024
Finland Finland
Not recruiting
06.05.2024
France France
Not recruiting
06.05.2024
Germany Germany
Not recruiting
06.05.2024
Greece Greece
Not recruiting
06.05.2024
Italy Italy
Not recruiting
06.05.2024
Lithuania Lithuania
Not recruiting
06.05.2024
Poland Poland
Not recruiting
06.05.2024
Slovakia Slovakia
Not recruiting
06.05.2024
Spain Spain
Not recruiting
06.05.2024

Trial locations

Investigated Drugs:

Spesolimab is a medication being studied for its long-term safety in patients with Hidradenitis Suppurativa (HS). This trial is for participants who have already received spesolimab treatment for about 8 to 12 months in a previous trial. The goal is to understand how safe spesolimab is when used over a longer period.

Investigated Diseases:

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 tunnels under the skin and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. Factors such as genetics, hormones, and lifestyle may contribute to its development. The condition can significantly impact quality of life due to pain and discomfort.

Trial ID:
2023-508377-82-00
Protocol code:
1368-0130
Trial Phase:
Therapeutic use (Phase IV)

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