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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000100-20 | EudraCT Number |
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The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC
Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | 12 weeks treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value < 0.01 and a fold change ≤ -1.3 or ≥ 1.3. | Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 | Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85). | Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
| Percent Change in Faecal Calprotectin From Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium | |||
| Asklepios Kliniken Westklinikum Hamburg |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was an Phase IIa multi-centre, non-randomised, uncontrolled single arm), open-label, exploratory trial to assess biomarker changes in response to Interleukin-36 signalling blockade induced by treatment with spesolimab in patients with moderate to severe active Ulcerative colitis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spesolimab 1200 mg Intravenous (i.v.) | 1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2019 | Sep 9, 2020 |
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Percent change in faecal calprotectin from baseline to week 12 (day 85). |
| Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
| Percent Change in Faecal Lactoferrin From Baseline to Week 12 | Percent change in faecal lactoferrin from baseline to week 12 (day 85). | Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
| Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 | Number of participants with clinical remission (defined as Mayo score ≤2 points, and all subscores ≤1 point) at Week 12. The Mayo score is a composite disease activity score consisting of 4 items or subscores: stool frequency (relative to normal), rectal bleeding, physician's global assessment (PGA), and endoscopic appearance. The overall range of the Mayo score was 0 to 12 (higher scores being worse) and each subscore had a range of 0 to 3. | Week 12 (day 85) following start of treatment. |
| Number of Patients With Drug Related Adverse Events (AEs) | Number of patients with drug related adverse events (AEs) during the on-treatment period. | Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days. |
| Hamburg |
| 22559 |
| Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): patients who received at least 1 dose of study drug, who had a baseline and at least 1 post baseline measurement for any clinical efficacy or biomarker endpoint without any Important protocol deviation flagged for exclusion or rescue use on or after Visit 1b but prior to administration of the first dose of spesolimab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spesolimab 1200 mg Intravenous (i.v.) | 1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 | The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value < 0.01 and a fold change ≤ -1.3 or ≥ 1.3. | Completers analysis set: completed the trial medication through to end of trial visit, had a baseline and at least 1 post baseline measurement for any clinical efficacy or biomarker endpoint without any Important protocol deviation flagged for exclusion or rescue use on or after Visit 1b but prior to administration of the first dose of spesolimab. | Posted | Number | deregulated genes | Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12). |
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| Secondary | Percent Change in C-reactive Protein (CRP) From Baseline to Week 12 | Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | Posted | Median | Full Range | percentage change (%) | Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
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| Secondary | Percent Change in Faecal Calprotectin From Baseline to Week 12 | Percent change in faecal calprotectin from baseline to week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | Posted | Median | Full Range | percentage change (%) | Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
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| Secondary | Percent Change in Faecal Lactoferrin From Baseline to Week 12 | Percent change in faecal lactoferrin from baseline to week 12 (day 85). | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | Posted | Median | Full Range | percentage change (%) | Measurements done at baseline (day -8 to -6) and week 12 (day 85). |
|
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| Secondary | Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12 | Number of participants with clinical remission (defined as Mayo score ≤2 points, and all subscores ≤1 point) at Week 12. The Mayo score is a composite disease activity score consisting of 4 items or subscores: stool frequency (relative to normal), rectal bleeding, physician's global assessment (PGA), and endoscopic appearance. The overall range of the Mayo score was 0 to 12 (higher scores being worse) and each subscore had a range of 0 to 3. | Full analysis set (FAS): patients who received at least 1 dose of study drug, who had a baseline and at least 1 post baseline measurement for any clinical efficacy or biomarker endpoint without any Important protocol deviation flagged for exclusion or rescue use on or after Visit 1b but prior to administration of the first dose of spesolimab. | Posted | Number | 95% Confidence Interval | Participants | Week 12 (day 85) following start of treatment. |
|
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| Secondary | Number of Patients With Drug Related Adverse Events (AEs) | Number of patients with drug related adverse events (AEs) during the on-treatment period. | Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days. |
|
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Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days.
Safety analysis set (SAF): This patient set included all entered patients who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spesolimab 1200 mg Intravenous (i.v.) | 1200 milligram Spesolimab (infusion solution, BI 655130) was given for 12 weeks intravenously with a concentration of 20 milligram/milliliter every four weeks (on Day 1, Week 4, and Week 8). | 0 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2019 | Sep 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Change from baseline to Day 57 (week 8) |
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| Change from baseline to Day 85 (week 12) |
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