Study on Spesolimab for Adults with Pyoderma Gangrenosum Requiring Systemic Therapy

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What is this study about?

This clinical trial is focused on a skin condition called pyoderma gangrenosum, which is characterized by painful ulcers. The study is testing a treatment called spesolimab, also known by its code name BI 655130. Spesolimab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of spesolimab to a placebo, which is a substance with no active medication, to see if spesolimab is more effective in treating this condition.

The purpose of the study is to determine if spesolimab can help achieve complete healing of the ulcers caused by pyoderma gangrenosum. Participants in the study will receive either spesolimab or a placebo and will be monitored over a period of time to see if their ulcers heal completely. The study will last up to 52 weeks, with the main focus on the first 26 weeks to see if the ulcers close completely and remain healed for at least two weeks.

Throughout the study, participants will have regular check-ups to monitor their progress. The study aims to provide valuable information on whether spesolimab can be a safe and effective treatment option for people suffering from pyoderma gangrenosum. The ultimate goal is to find a treatment that can help reduce the area of the ulcers and improve the quality of life for those affected by this condition.

1 initial treatment phase

The trial begins with the administration of the medication spesolimab or a placebo. The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The goal of this phase is to evaluate the safety and effectiveness of spesolimab in treating the skin condition known as pyoderma gangrenosum.

2 monitoring and assessment

Throughout the trial, regular assessments are conducted to monitor the progress of the treatment. This includes checking the size and condition of the skin ulcers.

The primary aim is to achieve complete closure of the target ulcer, which means a 100% reduction in the ulcer area, by Week 26.

3 follow-up visits

Follow-up visits are scheduled to confirm the closure of the ulcer. These visits occur at least two weeks after the initial observation of complete closure.

Additional assessments may include measuring pain levels and checking for any recurrence of the ulcers.

4 secondary outcomes

Secondary outcomes include achieving complete closure of any measurable ulcer at any time up to Week 26, and a reduction in pain scores by Week 4.

The time to recurrence of the ulcers is also monitored up to Week 52 for those who achieved complete closure by Week 26.

Who Can Join the Study?

  • You must be an adult, which means you need to be at least 18 years old. If the age of consent is different where you live, those rules will be followed.
  • You need to sign a written consent form, which means you agree to participate in the study and understand what it involves.
  • You must have a confirmed diagnosis of ulcerative pyoderma gangrenosum. This is a skin condition that causes painful sores. Your condition should require treatment that affects your whole body, not just the skin. The diagnosis will be confirmed by a special committee.
  • You need to have at least one sore from pyoderma gangrenosum that is measurable, meaning it is at least 5 square centimeters in size. If you have more than one sore, the main one will be chosen by the study doctor and confirmed by a committee.
  • The sore you have should have been diagnosed within the last 6 months. If it has been longer than 6 months, the sore must still be active and getting worse, as judged by the study doctor and confirmed by a committee.
  • If you are a woman who can have children, you must be willing and able to use very effective birth control methods. These methods should have a very low chance of failing if used correctly.

Who Cannot Join the Study?

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions other than Pyoderma gangrenosum, which is a rare skin condition that causes painful ulcers.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care.
  • Patients who do not meet other specific health criteria required for the 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
Helse Stavanger HF Stavanger Norway
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Universita’ Di Pisa Pisa Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Hopital Prive D Antony Antony France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hopital Beaujon Clichy France
Paracelsus Medizinische Privatuniversitaet Salzburg Salzburg Austria
Hospital Universitario Virgen De La Victoria Malaga Spain
Ubkmdinvraoixmzuspfex Ervsn Adh Essen Germany
Iaekjl Iioudqro Fujauvayrayme Ovlniugeizk Rome Italy
Hqhhypky Ulfyxjlifh Civsfip Haamwniv Helsinki Finland
Akqhuch Onwzykvejiz Uxvbuuuqpbkam Cnxxxblipqkb Dkfrb Sgzpnp E Dovpc Swuieoo Dl Tpuxfm Turin Italy
Umdnklkodfkgpuajbrjkq Wyyizzlff Aae Wuerzburg Germany
Uymnitpfoj Dande Ssysf Dv Rlsd Lz Svsylbuc Rome Italy
Minolrx Sdignrp Zcizueqtw w Ooevvmxam Olsztyn Poland
Jptobaiw Kqvukl Ueiktiwwgt Linz Austria

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
17.01.2025
Belgium Belgium
Recruiting
17.01.2025
Finland Finland
Recruiting
17.01.2025
France France
Recruiting
17.01.2025
Germany Germany
Recruiting
17.01.2025
Italy Italy
Recruiting
17.01.2025
Norway Norway
Recruiting
17.01.2025
Poland Poland
Recruiting
17.01.2025
Portugal Portugal
Recruiting
17.01.2025
Spain Spain
Recruiting
17.01.2025
Sweden Sweden
Recruiting
17.01.2025

Trial locations

Investigated drugs:

Spesolimab is a medication being studied for its potential to help patients with ulcerative pyoderma gangrenosum, a condition that causes painful skin ulcers. The trial aims to see if spesolimab can effectively close these ulcers completely, improving the patient’s condition.

Investigated diseases:

Pyoderma gangrenosum – Pyoderma gangrenosum is a rare skin condition characterized by the rapid development of painful ulcers. It often begins as small, red bumps that quickly progress to open sores with a purplish border. The ulcers can vary in size and may merge to form larger areas of skin damage. This condition is often associated with systemic diseases like inflammatory bowel disease or arthritis. The exact cause is not well understood, but it is believed to involve an abnormal immune response. The progression of the disease can be unpredictable, with periods of healing and flare-ups.

Trial ID:
2024-514306-31-00
Protocol code:
1368-0140
Trial Phase:
Therapeutic confirmatory (Phase III)

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