Maintenance trial of BI 655064 in patients with lupus nephritis
Research type
Research Study
Full title
An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10.
IRAS ID
248470
Contact name
Amrit Singh
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2017-003101-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 30 days
Research summary
Summary of Research
This study is an exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10. Lupus Nephritis is an inflammation of the kidney which is caused by an autoimmune disease called Systemic Lupus Erythematous (SLE). Patients will be randomised to two groups: Group 1: will involve approximately 60 patients to roll over from 1293.10; Group 2: will involve up to 90 patients from outside to be entered only if the 1293.10 interim analysis result meets the pre-defined criteria. Patient safety will be determined by assessments include physical examination, vital signs, ECG, safety laboratory tests and adverse events. Each patient's participation in the trial will last approximately 15 months and require approximately 11 visits to the trial clinic.Summary of Results
A study to test long term treatment with BI 655064 in people with lupus nephritis who took part in a previous study with BI 655064 This is a summary of results from this clinical study and a previous study of BI 655064.
We thank all study participants. You helped us to answer important questions about BI 655064 and the treatment of lupus nephritis.What was this study about?
The purpose of this study was to find out whether a medicine called BI 655064, in addition to standard of care, can help people with lupus nephritis. Lupus nephritis is an inflammation of the kidney caused by an autoimmune disease called systemic lupus erythematosus. Up to 60% of people with this disease will develop lupus nephritis. The inflammation can be severe, leading to loss of kidney function. We wanted to see if long-term treatment with different doses of BI 655064 helps to improve kidney function in people with lupus nephritis.Who took part in this study?
Adults with lupus nephritis took part in this study. They were invited to participate because they had shown a good response to treatment during a previous study 1293 0010.
A total of 69 participants took part in this study. There were 8 men and 61 women. The average age was 35 years. The youngest participant was 18 years old, and the oldest participant was 62 years old.
This study took place in Australia (less than 3 participants), Canada (less than 3 participants), Czech Republic (3 participants), Germany (less than 3 participants), Greece (5 participants), Hong Kong (less than 3 participants), Japan (6 participants), Malaysia (less than 3 participants), Mexico (13 participants), Philippines (4 participants), Poland (6 participants), Portugal (3 participants), South Korea (less than 3 participants), Thailand (13 participants), United Kingdom (3 participants), and United States (5 participants). The total number of participants in the European Union was 19.How was this study done?
Participants who achieved a meaningful response to treatment in the previous study, continued to receive the same dose as they received in the previous study (1293-0010).
The participants were divided into 4 groups. The groups were:
• Low dose BI 655064 group
• Medium dose BI 655064 group
• High dose BI 655064 group
• Placebo group
Participants received study treatment once a week as an injection under the skin. Placebo injections looked like BI 655064 but did not contain any medicine.
Participants and doctors did not know in which group the participants were. During the study, participants also received standard medication for lupus nephritis.
We wanted to see if a second year of treatment with BI 655064 helps to further improve the participants’ kidney function. To find out, we did urine and blood tests to see how well the kidneys were working. After the second year of treatment, we compared the percentage of participants with improved kidney function between treatment groups.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
We found that a second year of treatment with BI 655064 did not help to further improve kidney function.Did participants have any unwanted effects?
Yes, participants in all groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by BI 655064 or placebo.
• 4 out of 7 participants (57%) who took the low dose of BI 655064 for 2 years had unwanted effects.
• 3 out of 15 participants (20%) who took the medium dose of BI 655064 for 2 years had unwanted effects.
• 14 out of 21 participants (67%) who took the high dose of BI 655064 for 2 years had unwanted effects.
• 15 out of 26 participants (58%) who took placebo for 2 years had unwanted effects.The listings below show the most common unwanted effects in the BI 655064 group and how many participants had each of these unwanted effects.
Upper respiratory tract infection
• BI 655064 low dose (7 participants): 1 participant (14%)
• BI 655064 medium dose (15 participants): 2 participants (13%)
• BI 655064 high dose (21 participants): 3 participants (14%)
• Placebo (26 participants): 5 participants (19%)Shingles (herpes zoster)
• BI 655064 low dose (7 participants): 1 participant (14%)
• BI 655064 medium dose (15 participants): 0 participants
• BI 655064 high dose (21 participants): 3 participants (14%)
• Placebo (26 participants): 0 participants
Urinary tract infection
• BI 655064 low dose (7 participants): 0 participant
• BI 655064 medium dose (15 participants): 0 participants
• BI 655064 high dose (21 participants): 2 participants (10%)
• Placebo (26 participants): 4 participants (15%)Rash
• BI 655064 low dose (7 participants): 0 participant
• BI 655064 medium dose (15 participants): 0 participants
• BI 655064 high dose (21 participants): 2 participants (10%)
• Placebo (26 participants): 3 participants (12%)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. In this study, 4 participants (19%) in the high dose BI 655064 group had serious unwanted effects and 3 participants (12%) in the placebo group had serious unwanted effects.
1 participant (5%) in the high dose BI 655064 group died from unwanted effects.Where can I find more information about this study?
You can find further information about this study at these websites:
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0f5aa59650ab407966cf08da7b891f8c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637958126140377047%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XLrKyO214FpF2kRhDnk9zU57JSczs5NPwxJXjb8RiRU%3D&reserved=0 and search for the EudraCT number 2017-003101-17.
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0f5aa59650ab407966cf08da7b891f8c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637958126140377047%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=nOCBCLwatDbuGhWLVGGnS0vKghFws0UwSNr%2BGUCXFYE%3D&reserved=0 search for the NCT number: NCT03385564
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%7C0f5aa59650ab407966cf08da7b891f8c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637958126140377047%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=a9HFTn4fcpJ%2B6D2rgWxxkb%2FNcuacFei8p8ujlxrfS8g%3D&reserved=0.
The full title of the study is: An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10.
This was a Phase II study. This study started in January 2018 and finished in July 2021.
Are there additional studies?
If we do more clinical studies with BI 655064, you will find them on the websites listed above. To search for these studies, use word BI 655064.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
East of England - Essex Research Ethics Committee
REC reference
18/EE/0223
Date of REC Opinion
13 Jul 2018
REC opinion
Favourable Opinion