Open label long-term trial of BI 655130 in ulcerative colitis patients
Research type
Research Study
Full title
An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials.
IRAS ID
246858
Contact name
Jill Dincki
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2018-000334-35
Duration of Study in the UK
11 years, 5 months, 30 days
Research summary
Summary of Research
This is an open label, long term (7 year) safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous induction trials 1368-0004 or 1368-0005 (part I). Those patients that achieved a clinical response to study treatment (placebo or BI 655130) at completion of the original study will immediately switch to long-term subcutaneous treatment. Those patients that did not achieve a clinical response in the original study, will first receive BI 655130 high dose intravenous re-induction treatment for 12 weeks. Those patients who subsequently achieve a clinical response will be eligible to roll-over to long-term subcutaneous BI 655130 treatment.
Each participant will take part in the study for up to approximately 353 weeks, if they experience a long-lasting benefit from such treatment. This study will include 1 week of screening, 336 weeks of treatment (study drug will be given every 12 weeks) and 16 weeks of follow-up. Each participant will need to attend the study centre approximately 31 times (if they responded to treatment in the previous study), or 35 visits (if they did not respond in the previous study) and will require 12 additional weeks for intravenous re-induction.
This study will measure how safe, effective and tolerable the drug is over a long period as well as looking at pharmacokinetics, biomarkers and immunogenicity in blood, stool and colon biopsies.
Summary of Results
BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis 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 ulcerative colitis.What was this study about?
The purpose of this study was to find out whether a medicine called spesolimab (BI 655130) helps people with ulcerative colitis. Ulcerative colitis causes inflammation of the part of the gastrointestinal tract called the large intestine (colon). It can be painful and debilitating.
In this study, we wanted to find out how people with moderate to severe ulcerative colitis, who completed treatment with spesolimab in previous studies, would tolerate spesolimab over a long period of time.
The study was stopped early. This was because we decided to stop the development of spesolimab in ulcerative colitis.Who took part in this study?
Participants could take part in this study if they
• were 18 years or older
• took part in a previous study with spesolimab
• were willing to continue the treatment with spesolimab79 people took part in this study. Participants received maintenance directly or after re induction treatment, depending on the response in previous studies with spesolimab:
Maintenance treatment (MT): 34 participants received MT. There were 22 men and 12 women. The youngest participant was 22 years old, and the oldest participant was 73 years old. The average age was 41 years.
Re-induction treatment (RT): 57 participants received RT. There were 35 men and 22 women. The youngest participant was 19 years old, and the oldest participant was 73 years old. The average age was 44 years.How was this study done?
The participants either received MT directly or after RT, depending on the response in previous studies:
• Maintenance treatment: participants who had treatment improvement at the end of the previous study received a spesolimab injection under the skin of 300 mg every 4 weeks.
• Re-induction treatment: participants who did not have treatment improvement at the end of the previous study received a spesolimab infusion into a vein of 1200 mg every 4 weeks for 3 times. At week 12, participants who had treatment improvement switched to the maintenance treatment.
The participants and doctors knew which treatment the participants were getting.
Treatment was planned to last about 7 years. However the study was stopped early.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
In this study, we wanted to find out the number of participants that had at least 1 health problem during the study. 29 out of 34 participants (85%) had at least 1 health problem during the MT period. 36 out of 57 participants (63%) had at least 1 health problem during the RT period. Spesolimab was tolerated by the participants, as expected.Did participants have any unwanted effects?
Yes, participants in both treatments had unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicine.
During MT, 10 out of 34 participants (29%) had unwanted effects. During RT, 12 out of 57 participants (21%) had unwanted effects. The most common unwanted effects were: inflammation of the bowel causing ulceration and bleeding (colitis ulcerative) in MT and joint pain (arthralgia) in RT.
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 did the study take place?
The following listing shows the regions and countries with the number of participants.
Europe (56): Austria (4), Belgium (5), Germany (15), Italy (13), Poland (1), Russian Federation (6), Spain (3), United Kingdom (9) North America (13): United States (12), Canada (1) Asia (10): Japan (8), Republic of Korea (2) The total number of participants in the European Union was 41.Is there more information about this study?
You can find further information about this study at these websites:
1. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315557499%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QzcKPwFCIlj2iOiER0rbnPFFH4M2%2F4rVVDs8ZoANbkI%3D&reserved=0 and search for the EudraCT number 2018-000334-35.
2. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315576840%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=PZmWLnqw2QcDtfNdjfn3pwB4aJZXgeJde12bhSMJZFU%3D&reserved=0 and search for the NCT number NCT03648541.
Boehringer Ingelheim sponsored this study. For contact details, please visit https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315594754%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=oLa6D%2Fmp3hvsaIHefdUf8zEp%2FKFTvlECjFFudSgO1v4%3D&reserved=0.
The full title of the study is: An open-label, long-term safety trial of BI 655130 (SPESOLIMAB) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials This was a Phase 2 study. This study started in November 2018 and finished in May 2023.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.
©2024 Boehringer Ingelheim International GmbH
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: 1. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315613951%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=h4Jg0wBEqcAChi3hZnT0lhitLdfl8PfoDEdxnE6JRGU%3D&reserved=0 and search for the EudraCT number 2018-000334-35. 2. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315630488%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=VsFaBmvq0%2BbNA4AYd0PqdQOOgkFHoyjSVQ4ahC2O5tY%3D&reserved=0 and search for the NCT number NCT03648541.
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: This trial was prematurely ended due to the decision to discontinue the clinical development of spesolimab in inflammatory bowel disease. This decision was based on a lower-than-expected efficacy in previous clinical trials conducted in ulcerative colitis and fistulising Crohn's disease. The decision was not related to any safety findings. The trial was completed as described in the protocol.Internal report has been finalised.
The results are published on clinicaltrials.gov: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03648541%253Fterm%253D1368-0017%2526rank%253D1%2526tab%253Dresults%2FNBTI%2F58u3AQ%2FAQ%2F128d0d96-f3dc-4f77-8b12-0188fb027c8a%2F2%2FJwF7UrR6MH&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315647492%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=oL9yUctVo2VJzrGtYTSdYKwbEtzez%2Bjo7zLHZKOkLdQ%3D&reserved=0
Trial details published in journal: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.tandfonline.com%252Fdoi%252Ffull%252F10.1080%252F14740338.2022.2103536%253Fscroll%253Dtop%2526needAccess%253Dtrue%2FNBTI%2F58u3AQ%2FAQ%2F128d0d96-f3dc-4f77-8b12-0188fb027c8a%2F3%2FTWTn90JKOD&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315664610%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=guMkEiYEGeyu44U1r5oyXSrMkHklVv5ad807UVXQEGU%3D&reserved=0
Lay summary will also be made available online at: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.mystudywindow.com%252Ftrials%252Fdisease%252Fcompleted%252F-1%252FAll%253FtrialId%253D1368-0017%2FNBTI%2F58u3AQ%2FAQ%2F128d0d96-f3dc-4f77-8b12-0188fb027c8a%2F4%2F-EY4W7UBdk&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C76f474b3797a4ca560b008dcccf28ba4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638610589315679736%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=FgyuhFTs44tW%2BUNl7Q7XfgGrvKwdWv5Yxx243Yvc5fU%3D&reserved=0
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1387
Date of REC Opinion
3 Oct 2018
REC opinion
Further Information Favourable Opinion