1368-0052 Phase IIa spesolimab in hidradenitis suppurativa
Research type
Research Study
Full title
Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa
IRAS ID
291302
Contact name
Ser-Ling Chua
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2020-003672-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 5 days
Research summary
Research Summary
This is a phase II trial of an experimental drug, called spesolimab, in patients with moderate to severe hidradenitis suppurativa. After signing informed consent, participants will complete an initial 4-week screening period, where they will be assessed to see if they are suitable for the study. Patients found to be suitable will be assigned at random to receive either spesolimab, or a placebo, and both the patient and the study/sponsor team will not be aware of which one the patient is assigned to. Patients will be assigned to a treatment arm and receive an initial higher dose, 3600mg, of intravenous spesolimab/or placebo for the first 3 weeks, followed by injections of a lower dose, 1200mg, spesolimab/placebo every 2 weeks, for a total treatment duration of 12 weeks. At week 12, patients will attend for an end of treatment visit. At this point eligible patients, who are willing, will enter an open label extension study to receive spesolimab, with no placebo arm. Patients who permanently discontinue trial drug earlier than week 12, or do not qualify to enter the extension trial for any other reason, will be invited to do the end of treatment visit instead of the next planned visit, and will then enter a 16 weeks safety follow-up period. After 16 weeks patients will attend the end of study visit and will finish their participation in the study after completing this visit.
Approximately 45 patients will be entered into the study, with a sufficient number screened to reach this target. Patients will be assigned to their treatment arm in a 2:1 ratio to either spesolimab or placebo. Patients will also be stratified on whether previous treatment of those of the TNFi-naive population (Tumor necrosis factor inhibitors) versus those of the TNFi-failure population. Approximately 33 patients from TNFi-naive population and 12 patients from TNFi-failure population are planned to be randomized respectively.
Summary of Results
This is a summary of results from 1 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 helps people with moderate to severe hidradenitis suppurativa. Hidradenitis suppurativa, also called acne inversa, is a skin disease that causes painful lumps, boils and scarring on the skin, as well as mental distress. 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.
Spesolimab is already used to treat another skin disease called generalised pustular psoriasis (GPP).
Who took part in this study?
People could take part in this study if they were 18 years of age or older and had hidradenitis suppurativa for at least 1 year.
A total of 52 people took part in the study. This included 21 men and 31 women. The average age of the participants was 35 years. The youngest participant was 20 years old and the oldest participant was 61 years old.
This study was done in 12 different countries.
The following listing shows the numbers of participants in the study in different countries:
• Europe (35 participants): Belgium, Czech Republic, France, Germany, Italy, Netherlands, Norway, Poland, Spain
• North America (9 participants): Canada, USA
• Asia (8 participants): Australia
How was this study done?
The participants were divided into 2 groups. The groups were:
• Spesolimab group
• Placebo group
All participants got an infusion of 1200 milligrams (mg) of spesolimab or placebo into a vein once per week for 3 weeks. After that, they got a total of 4 injections under the skin of 1200 mg of spesolimab or placebo, one every 2 weeks for a total of 9 weeks.
Placebo infusions and injections looked like spesolimab infusions and injections but did not contain any medicine. We compared spesolimab with placebo to find out how well spesolimab works.
Every participant had twice the chance of being placed in the spesolimab group than in the placebo group. The participants and doctors did not know whether the participants were in the spesolimab group or in the placebo group.
Participants were treated for 12 weeks. After this time, they were offered the chance to join another clinical study, in which all the participants got spesolimab, or to stay in this study for 16 more weeks (without taking spesolimab or placebo).
Participants visited the doctors regularly. At this study, doctors measured the number of lumps and boils on the skin of all participants. During these visits, the doctors also collected information about the participants’ health.
What were the results of this study?
After taking spesolimab for 3 months, the reduction in the total number of lumps and boils on the skin of the participants was similar in the spesolimab and placebo groups. There were other signs that skin damage tended to improve in participants receiving spesolimab. Therefore, it is worth doing further research to find out whether spesolimab helps people with hidradenitis suppurativa.
Did participants have any unwanted effects?
Yes, participants in both groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by spesolimab or placebo. In this study, 15 out of 36 participants (42%) in the spesolimab group had unwanted effects. 3 out of 16 participants (19%) in the placebo group had unwanted effects.
The listing below shows the most common unwanted effects in the spesolimab group. The listing also shows how many participants had each of these unwanted effects:
Headache
• Spesolimab (36 participants): 3 participants (8%)
• Placebo (16 participants): 2 participants (13%)
Pain at the injection site
• Spesolimab (36 participants): 3 participants (8%)
• Placebo (16 participants): 1 participant (6%)
Redness at the injection site (injection site erythema)
• Spesolimab (36 participants): 3 participants (8%)
• Placebo (16 participants): 0 participants
Acne
• Spesolimab (36 participants): 2 participants (6%)
• Placebo (16 participants): 0 participants
Fatigue
• Spesolimab (36 participants): 2 participants (6%)
• Placebo (16 participants): 0 participants
Nausea
• Spesolimab (36 participants): 2 participants (6%)
• Placebo (16 participants): 0 participants
None of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, that they were not life-threatening, and that they did not lead to a disability.
Where can I find more information about this study?
You can find further information about this study at these websites:
1. Go to www.mystudywindow.com and search for the study number 1368-0052.
2. Go to www.clinicaltrialsregister.eu/ctr-search and search for the EudraCT number 2020-003672-40.
3. Go to www.clinicaltrials.gov and search for the NCT number NCT04762277.
Boehringer Ingelheim sponsored this study. For contact details, please visit www.boehringer-ingelheim.com/contact-us.
The full title of the study is: Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate to severe hidradenitis suppurativa
This was a Phase IIa study. This study started in May 2021 and finished in April 2022.
Are 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.
©2023 Boehringer Ingelheim International GmbHREC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0116
Date of REC Opinion
7 Jun 2021
REC opinion
Further Information Favourable Opinion