1368-0067 Extension study spesolimab in hidradenitis suppurativa
Research type
Research Study
Full title
An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)
IRAS ID
297359
Contact name
Ser-Ling Chua
Contact email
Sponsor organisation
Boehringher Ingleheim
Eudract number
2020-005587-55
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 4 months, 20 days
Research summary
Research Summary
This is an open label extension study for patients who have successfully completed the treatment period of the parent
study, 1368-0052. This trial investigates the long-term safety and efficacy of spesolimab in patients with Hidradenitis
Suppurative, with all patients receiving active treatment for up to 104 weeks, followed by a 16 week safety follow up
period.Ideally, the end of treatment visit for the preceding trial will be visit 1 for this study. Patients from the placebo arm of
the 1368-0052 trial will be given an initial 1200 mg intravenous infusion loading dose of spesolimab, plus a subcutaneous
injection placebo (inactive drug), followed by 600 mg spesolimab sub-cutaneous injection every two weeks
for the remainder of the study. Patients from the active arm of the 1368-0052 trial will be given an initial intravenous
infusion of placebo plus 600 mg spesolimab sub-cutaneous injection, followed by 600 mg spesolimab subcutaneous
injection every 2 weeks for the remainder of the study. Administration of trial medication at Visit 1 is blinded
so that no one knows at that point which patients from the parent study received active or placebo treatment.
After 12 weeks of treatment, all patients on the study will be assessed for efficacy by measuring the change of HS-PGA
grade from the grade at visit 1 of the study. Based on the individual response at week 12, it will then be decided what
further treatment regimen each patient will follow according to the dose modification table provided in the protocol.
Patients may have their dose of Spesolimab Injection increased at week 12 (or potentially week 24) depending on
their response to treatment.At the end of the treatment period, patients will enter a 16 week follow up period for safety. Approximately 45 patients
are planned to roll over into this study.Summary of Results
This Lay Summary was developed with patients who were not involved in this clinical study.
We thank all study participants. You helped us to answer important questions about spesolimab and the treatment of hidradenitis suppurativa.What was this study about?
The purpose of this study was to find out whether a medicine called spesolimab is safe for people with hidradenitis suppurativa, when taken for a long time.
Hidradenitis suppurativa, also called acne inversa, is a skin disease that causes painful lumps, boils and scarring on the skin These usually develop on the armpits, groin, and other areas of the body. An early treatment can improve the symptoms and prevent it from getting worse.Who took part in this study?
People could take part in the study if they had completed treatment in the previous study 1368-0052 for spesolimab.
45 people took part in this study. There were 18 men and 27 women.
The youngest participant was 20 years old, and the oldest participant was 60 years old. The average age was 36 years.
Participants were between 20 and 60 years old.
Participants were from different backgrounds: White, Asian, Hawaiian/Pacific Islander, Black/African American, and not stated.
This diversity makes the findings relevant to a wide range of people.How was this study done?
The study had 2 parts.
Part 1 study (from the start until week 2): participants received a single high or low dose of spesolimab. To make sure that no one knew who took which medicine, participants also got placebo. The placebo looked like spesolimab but did not contain any medicine. Participants received spesolimab or placebo either as an infusion into the vein or as an injection under the skin depending on their previous study treatment.
Part 2 study (from week 2 to week 12): all participants received a low dose of spesolimab as an injection under the skin once every 2 weeks. At the end of week 12, all participants were assessed for improvement in their symptoms. Participants continued to receive the same dose or a higher dose of spesolimab depending on how they responded to the treatment. The participants and doctors knew which treatment the participants were getting.Participants were treated in this study for up to 2 years and 4 months. Participants visited the doctors regularly. During these visits, the doctors collected information about the participants' health and noted any health problems.
What were the results of this study?
43 out of 45 participants (96%) in this study had at least one adverse event. Adverse events are any health problems that happen during the study. These health problems may or may not have been caused by the study medicine.Did participants have any unwanted effects in this study?
Yes, participants in this study had unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicine. In this study, 19 out of 45 participants (42%) on spesolimab had unwanted effects.
The listing below shows the 7 most common unwanted effects in participants on spesolimab. The listing also shows how many out of 45 participants had each of these unwanted effects.
Redness at the injection site (Injection site erythema): 3 participants (7%) Bruise at the injection site (Injection site haematoma): 2 participants (4%) Pain at the injection site (Injection site pain): 2 participants (4%) Itching at the injection site (Injection site pruritus): 2 participants (4%) Swelling at the injection site (Injection site swelling): 2 participants (4%) Infection of the sinuses (Sinusitis): 2 participants (4%) Infection of nose, sinuses, throat, and/or vocal cords (Upper respiratory tract infection): 2 participants (4%) Some unwanted effects in this study were serious because: they required a stay in hospital, or if already in the hospital, they made the stay last longer; they were life-threatening; they were fatal; they led to a disability.
In this study, 1 participant on spesolimab had serious unwanted effectsWhere did the study take place?
The following listing shows the regions and countries with the number of participants.
Europe (28): Czech Republic (2), France (4), Germany (7), Italy (4), Netherlands (4), Norway (1), Poland (5), Spain (1) North America (9): Canada (2), USA (7) Other countries (8): Australia (8) The total number of participants in the European Union was 27.Is there more information about this study?
More scientific details are available. You can find further information about this study at these websites:
1. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.mystudywindow.com%2Fcompleted&data=05%7C02%7CWales.REC5%40Wales.nhs.uk%7C1ff850e0bb964c24740808dd8406b7fd%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638811886600705688%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=16cS5K67O2Tz9Uru6HteG%2BskBr%2BIM6I12%2BTgR48G3WQ%3D&reserved=0 and search for the study number 1368-0067.
2. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7CWales.REC5%40Wales.nhs.uk%7C1ff850e0bb964c24740808dd8406b7fd%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638811886600723230%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Yr1hZ5qDNVnvR8ypSwNQC6uy67QCivoHcwBtG2z87Wk%3D&reserved=0 and search for the EudraCT number 2020-005587-55.
3. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7CWales.REC5%40Wales.nhs.uk%7C1ff850e0bb964c24740808dd8406b7fd%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638811886600742047%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=DiIdo4kJzsRUz2xN9DUN685IxRph7A26hTez%2BM4oDmo%3D&reserved=0 and search for the NCT number NCT04876391.
Boehringer Ingelheim sponsored this study. For contact details, please visit https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C02%7CWales.REC5%40Wales.nhs.uk%7C1ff850e0bb964c24740808dd8406b7fd%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638811886600759245%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=DIH6NEp5iT1q7mJH8K%2FrNjZfxcXE3GUYzp%2FzkckOJ5c%3D&reserved=0.
The full title of the study is: An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis suppurativa (HS) This was a Phase II study. This study started in August 2021 and finished in April 2024Are there additional studies?
If we do more clinical studies with spesolimab, you will find them on the websites listed above. To search for these studies, use the words spesolimab and BI 655130.Important notice
This lay summary is provided as part of Boehringer Ingelheim's commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2025 Boehringer Ingelheim International GmbHREC name
Wales REC 5
REC reference
21/WA/0201
Date of REC Opinion
25 Aug 2021
REC opinion
Further Information Favourable Opinion