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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2011-004812-40 |
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| Name | Class |
|---|---|
| MedImmune Ltd | INDUSTRY |
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | tralokinumab (CAT-354) sc injection |
|
| 2 | Placebo Comparator | placebo sc injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tralokinumab | Drug | 2 sc injections of every 2 weeks for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at Week 8 Based on Mayo Score | Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. | Eight week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mayo Score From Baseline to Week 8 | Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline. | Eight week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Berner Hansen, MD, PhD | AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden | Study Director |
| Silvio Danese, MD, PhD | IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | České Budějovice | Czechia | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304132 | Result | Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10. |
| Label | URL |
|---|---|
| D2211C00001\_Protocol\_Redacted | View source |
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Participants were enrolled for a period of 3 weeks.
147/111 patients were enrolled/randomized from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tralokinumab | Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2. |
| FG001 | Placebo | Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
2 sc injections of every 2 weeks for 12 weeks. |
|
| Mucosal Healing at Week 8 Based on Mayo Score | Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points. | Eight week treatment period |
| Clinical Remission at Week 8 Based on Mayo Score | Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. | Eight week treatment period |
| Change From Baseline in Partial Mayo Score | The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline. | From baseline to Week 4, 8, 12, 16, 20, and 24. |
| Change From Baseline in Modified Riley Score | Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration. | Eight week treatment period |
| Change From Baseline in C - Reactive Protein | From baseline to Week 4, 8, 12, 16, 20, and 24. |
| Change From Baseline in Albumin | From baseline to Week 4, 8, 12, 16, 20, and 24. |
| Change From Baseline in Calprotectin | From baseline to Week 4, 8, 12, 16, 20, and 24. |
| Serum Concentration of Tralokinumab | Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24. |
| Immunogenicity | Incidence of anti-drug antibodies (ADA) to tralokinumab in serum. | Pre-dose sampling at baseline, Week 8, 12, 16, and 24. |
| Hradec Králové |
| Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Amiens | France |
| Research Site | Caen | France |
| Research Site | Clichy | France |
| Research Site | Nice | France |
| Research Site | Pessac | France |
| Research Site | Rouen | France |
| Research Site | Vandœuvre-lès-Nancy | France |
| Research Site | Ludwigshafen | Germany |
| Research Site | Oelde | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Wangen | Germany |
| Research Site | Florence | Italy |
| Research Site | Padova | Italy |
| Research Site | Roma | Italy |
| Research Site | Rozzano | Italy |
| Research Site | Bydgoszcz | Poland |
| Research Site | Częstochowa | Poland |
| Research Site | Lodz | Poland |
| Research Site | Sopot | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Cambridge | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Oxford | United Kingdom |
| Research Site | Shrewsbury | United Kingdom |
| D2211C00001\_Study\_Synopsis | View source |
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomised participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tralokinumab | Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2. |
| BG001 | Placebo | Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Duration of disease | Mean | Standard Deviation | Years |
| |||||||||||||||
| Mayo score at baseline | Mayo score is the sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. | Mean | Full Range | Scores on scale |
| ||||||||||||||
| Partial Mayo score at baseline | The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. | Mean | Full Range | Scores on scale |
| ||||||||||||||
| Glucocorticosteroid-refractory status | Yes: if participants had received a glucocorticosteroid treatment prior to baseline and the outcome of that treatment was no improvement. No: If the outcome of the treatment was improvement or missing. Unknown: If the outcome of the treatment was unknown. | Number | Participants |
|
| 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 | Clinical Response at Week 8 Based on Mayo Score | Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. | The full analysis set consist of all randomised participants | Posted | Number | Percentage of responders | Eight week treatment period |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mayo Score From Baseline to Week 8 | Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline. | The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data. | Posted | Least Squares Mean | Standard Error | Score on scale | Eight week treatment period |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mucosal Healing at Week 8 Based on Mayo Score | Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points. | The full analysis set consist of all randomised participants | Posted | Number | Percentage of participants | Eight week treatment period |
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| Secondary | Clinical Remission at Week 8 Based on Mayo Score | Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. | The full analysis set consist of all randomised participants | Posted | Number | Percentage of participants | Eight week treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Partial Mayo Score | The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline. | The full analysis set consist of all randomised participants | Posted | Mean | Full Range | Score on scale | From baseline to Week 4, 8, 12, 16, 20, and 24. |
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| Secondary | Change From Baseline in Modified Riley Score | Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration. | The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data. | Posted | Least Squares Mean | Standard Error | Grade on scale | Eight week treatment period |
|
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| Secondary | Change From Baseline in C - Reactive Protein | The full analysis set consist of all randomised participants | Posted | Mean | Full Range | mg/L | From baseline to Week 4, 8, 12, 16, 20, and 24. |
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| Secondary | Change From Baseline in Albumin | The full analysis set consist of all randomised participants | Posted | Mean | Full Range | g/L | From baseline to Week 4, 8, 12, 16, 20, and 24. |
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| Secondary | Change From Baseline in Calprotectin | The full analysis set consist of all randomised participants | Posted | Mean | Full Range | ug/g | From baseline to Week 4, 8, 12, 16, 20, and 24. |
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| Secondary | Serum Concentration of Tralokinumab | The safety analysis set consist of all randomised participants who received at least one dose of study medication. | Posted | Mean | Full Range | ug/ml | Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24. |
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| Secondary | Immunogenicity | Incidence of anti-drug antibodies (ADA) to tralokinumab in serum. | The safety analysis set consist of all randomised participants who received at least one dose of study medication. | Posted | Number | participants | Pre-dose sampling at baseline, Week 8, 12, 16, and 24. |
|
|
24 Weeks
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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 | Placebo | Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2. | 6 | 55 | 35 | 55 | ||
| EG001 | Tralokinumab 300 mg | Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2. | 7 | 55 | 36 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| SERUM SICKNESS | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 16.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 16.0 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 16.0 | Systematic Assessment |
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| INJECTION SITE REACTION | General disorders | MedDRA 16.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 16.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| ABDOMINAL TENDERNESS | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 16.0 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Berner Hansen | AstraZeneca | +46 31 776 4794 | Mark.Berner.Hansen@astrazeneca.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C574065 | tralokinumab |
Not provided
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Not provided
| Male |
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| White |
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| Other |
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| Asian (Other than Chinese And Japanese) |
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| Not Applicable |
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| Other |
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| No |
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| Unknown |
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