BI 655130 in patients with Palmoplantar Pustulosis
Research type
Research Study
Full title
Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP)
IRAS ID
265764
Contact name
Andrew Pink
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2018-003078-28
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Research Summary
This study will test how effective and safe different doses of an investigational drug called BI655130 are in patients with a moderate to severe form of the skin disease Palmoplantar Pustulosis (PPP). Eligible participants will be assigned by random selection to receive either BI655130 (at one of four dosing regimens) or an inactive substance called placebo. The clinical effect will be measured, as well as the safety and tolerability of treatment with BI655130 over 52 weeks. After 16 weeks of treatment all participants who are receiving placebo will be switched over to receive active BI655130, so that from week 16 to week 52 all participants are receiving active drug. The study is double-blinded which means no one (including the participants and the study team) will know which patient receives placebo and which receives active investigational drug. Approximately 3 people will participate in this study in the United Kingdom and approximately 140 people will participate world-wide.
Summary of Results
A study to test how effective and safe different doses of spesolimab are in patients with a moderate to severe form of the skin disease palmoplantar pustulosis 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 palmoplantar pustulosis.
What was this study about?
The purpose of this study was to find out whether a medicine called spesolimab helps people with palmoplantar pustulosis.
Palmoplantar pustulosis is a skin disease that causes blisters filled with pus on the palms of the hands and soles of the feet. It can be very painful and can make using the hands or walking difficult. The available treatment options are not very effective in reducing the duration and severity of the disease, and there is currently no cure. Hence, there is a need for new treatments for palmoplantar pustulosis.Who took part in this study?
Adults with active moderate to severe palmoplantar pustulosis could take part in this study.
152 participants took part in this study. There were 110 women and 42 men. The youngest participant was 22 years old and the oldest participant was 75 years old. The average age was 54 years.
This study took place in Korea (7 participants), Taiwan (less than 3 participants), Japan (52 participants), Australia (6 participants), Belgium (4 participants), Canada (8 participants), Czech Republic (less than 3 participants), France (11 participants), Germany (16 participants), Hungary (5 participants), Poland (13 participants), Netherlands (less than 3 participants), Russia (10 participants), United Kingdom (less than 3 participants), and the United States (14 participants).
The total number of participants in each country is mentioned within parenthesis.
The total number of participants in the European Union was 52.How was this study done?
The study tested 4 different doses of spesolimab received as an injection under the skin. At the start of the study, participants were put into 5 groups. It was decided by chance who gets into which group. 4 groups got different doses of spesolimab as an injection under the skin. The 5th group got placebo as an injection under the skin. The placebo injection looked like the spesolimab injection but did not contain any medicine.
During the study, participants received a spesolimab or placebo injection every week and later every 4 weeks for the first 16 weeks. After 16 weeks, all participants, including those on placebo before, received a spesolimab injection every 4 or 8 weeks. Participants received their assigned treatment for 1 year.
The participants and doctors did not know in which group the participants were.
We wanted to see if the different doses of spesolimab helped participants with palmoplantar pustulosis more than placebo. To do this, we compared the change in participants’ symptoms and the area of skin that was affected by palmoplantar pustulosis before taking spesolimab and 16 weeks later.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
After 16 weeks of treatment, we found that there was similar improvement of palmoplantar pustulosis among the participants who received the different doses of spesolimab. When compared to the participants who received placebo, palmoplantar pustulosis improved more for the participants who received spesolimab. But statistical tests showed that the difference between the treatment groups may be due to chance.
After the end of the study, we looked at the results in more detail. We found certain groups of participants taking spesolimab whose symptoms appeared to improve more than for participants who took placebo. But this needs to be checked in future studies.Did participants have any unwanted effects?
Yes, participants in all the groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by spesolimab.
Until Week 16
In this study until Week 16, 39 out of 109 participants (36%) in the spesolimab groups had unwanted effects. 13 out of 43 participants (30%) in the placebo group had unwanted effects.
The listing below shows the most common unwanted effects in the spesolimab high dose group. The listing also shows how many participants in each group had each of these unwanted effects.Injection site reaction
• Spesolimab low dose (22 participants): 2 participants (9%)
• Spesolimab medium-low dose (21 participants): 0 participants (0%)
• Spesolimab medium-high dose (22 participants): 3 participants (14%)
• Spesolimab high dose (44 participants): 14 participants (32%)
• Placebo (43 participants): 0 participants (0%)
Redness at the injection site (Injection site erythema)
• Spesolimab low dose (22 participants): 3 participants (14%)
• Spesolimab medium-low dose (21 participants): 0 participants (0%)
• Spesolimab medium-high dose (22 participants): 2 participants (9%)
• Spesolimab high dose (44 participants): 3 participants (7%)
• Placebo (43 participants): 0 participants (0%)Headache
• Spesolimab low dose (22 participants): 1 participant (5%)
• Spesolimab medium-low dose (21 participants): 0 participants (0%)
• Spesolimab medium-high dose (22 participants): 0 participants (0%)
• Spesolimab high dose (44 participants): 2 participants (5%)
• Placebo (43 participants): 1 participant (2%)Nausea
• Spesolimab low dose (0 participants): 0 participants (0%)
• Spesolimab medium-low dose (21 participants): 1 participant (5%)
• Spesolimab medium-high dose (22 participants): 0 participants (0%)
• Spesolimab high dose (44 participants): 2 participants (5%)
• Placebo (43 participants): 0 participants (0%)Irritation at the injection site
• Spesolimab low dose (22 participants): 0 participants (0%)
• Spesolimab medium-low dose (21 participants): 0 participants (0%)
• Spesolimab medium-high dose (22 participants): 0 participants (0%)
• Spesolimab high dose (44 participants): 2 participants (5%)
• Placebo (43 participants): 0 participants (0%)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.
After Week 16
In this study after Week 16, 39 out of 101 participants (39%) in the spesolimab groups had unwanted effects. 15 out of 38 participants (39%) in the group that moved from placebo to spesolimab had unwanted effects.
The listing below shows the most common unwanted effect in the spesolimab high dose group. The listing also shows how many participants in each group had this unwanted effect. Other unwanted effects happened in a lower number of participants.Injection site reaction
• Spesolimab low dose (21 participants): 3 participants (14%)
• Spesolimab medium-low dose (20 participants): 5 participants (25%)
• Spesolimab medium-high dose (20 participants): 4 participants (20%)
• Spesolimab high dose (40 participants): 14 participants (35%)
• Placebo (38 participants): 4 participants (11%)Some unwanted effects were serious because they required a stay in hospital or a longer stay in hospital. Unwanted effects were also serious if the doctor thought they were serious for any other reason. 2 participants (5%) in the spesolimab high dose group had serious unwanted effects.
Where can I find more information about this study?
You can find further information about this study at these websites:
• Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C01%7Capprovals%40hra.nhs.uk%7C70d89d010b194dd34a2708da81fa8b74%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637965210326273177%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=M5%2FrYB4G0x5de3T3Q6opXzbEXeTvYLDscXz26Gyhba0%3D&reserved=0 and search for the EudraCT number
018-003078-28.
• Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C70d89d010b194dd34a2708da81fa8b74%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637965210326273177%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=aEO6%2BjThnYXpLPsjI4u5FX7VGkMTQKAvZO4%2FRJuoixs%3D&reserved=0 and search for the NCT number NCT04015518.
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%7C01%7Capprovals%40hra.nhs.uk%7C70d89d010b194dd34a2708da81fa8b74%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637965210326273177%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sEOnEEWNu6qFy6uNTLGW3ZeY19plg4ikdr92jBHswwQ%3D&reserved=0.
The full title of the study is: Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP) This study started in August 2019 and finished in July 2021.
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.
People with palmoplantar pustulosis who took part in this study with spesolimab were also able to take part in an additional study with spesolimab (1368-0024).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.
©2022 Boehringer Ingelheim International GmbHREC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1021
Date of REC Opinion
25 Jul 2019
REC opinion
Further Information Favourable Opinion