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The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 |
|
| Placebo | Placebo Comparator | Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | 150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus Intensity Visual Analogue Scale Score at Week 32 | On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus. | Week 32 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Lead | Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bad Bentheim | 48455 | Germany | |||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Of the 132 subjects enrolled in the study, 130 entered the Run-In phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12 |
| FG001 | Secukinumab | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Phase (Week 0 to 16) |
|
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| Placebo | Biological | Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe) |
|
| Berlin |
| 10117 |
| Germany |
| Novartis Investigative Site | Bielefeld | 33647 | Germany |
| Novartis Investigative Site | Bochum | 44803 | Germany |
| Novartis Investigative Site | Dippoldiswalde-Schmiedeberg | 01744 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Gelsenkirchen | 45883 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Hamburg | 22391 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Leipzig | 04105 | Germany |
| Novartis Investigative Site | Mannheim | 68167 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Osnabrück | 49074 | Germany |
| Novartis Investigative Site | Selters | 56242 | Germany |
| Novartis Investigative Site | Stuttgart | 70176 | Germany |
| Novartis Investigative Site | Stuttgart | 70178 | Germany |
| FG002 | Placebo | Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 |
| COMPLETED |
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| NOT COMPLETED |
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| Randomized Withdrawal (Wk 16 to 32) |
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Full analysis set (randomized withdrawal phase) (FAS-R). All patients that received at least one dose of blinded study drug during the randomized withdrawal phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 |
| BG001 | Placebo | Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 |
| 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, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Pruritus Intensity Visual Analogue Scale Score at Week 32 | On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus. | FAS-R, LOCF | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 32 |
|
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Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year, 3 months.
The safety set included all patients that received at least one 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 | Run-In | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12 | 6 | 130 | 43 | 130 | ||
| EG001 | Secukinumab | 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 | 2 | 42 | 16 | 42 | ||
| EG002 | Placebo | Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 | 0 | 38 | 19 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ANEURYSM RUPTURED | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | (862) 778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Subject/guardian decision |
|
| Title | Measurements |
|---|---|
|
| Male |
|
| Black |
|