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Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.
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This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 | Experimental | AIN457 10 mg/kg |
|
| Placebo | Placebo Comparator | Placebo intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 (secukinumab) | Drug | Secukinumab intravenous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores. | Baseline and 85 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mainz | Germany | 55131 | Germany | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 | AIN457 10 mg/kg |
| FG001 | Placebo | Placebo intravenous injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 | AIN457 10 mg/kg |
| BG001 | Placebo | Placebo intravenous injection |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores. | The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received. | Posted | Least Squares Mean | 90% Confidence Interval | Score | Baseline and 85 Days |
|
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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 | AIN457 10 mg/kg | AIN457 10 mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TINNITUS | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Placebo |
| Drug |
Placebo intravenous injection |
|
| Wiesbaden |
| Germany |
| 65187 |
| Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Großhansdorf | 22927 | Germany |
| Novartis Investigative Site | London | United Kingdom | SE11YR | United Kingdom |
| Novartis Investigative Site | Leicester | LE3 9QP | United Kingdom |
| Novartis Investigative Site | London | SW3 6PH | United Kingdom |
| Novartis Investigative Site | Manchester | M23 9QZ | United Kingdom |
| Administrative problems |
|
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo intravenous injection
|
|
|
| 1 |
| 31 |
| 21 |
| 31 |
| EG001 | Placebo | Placebo | 2 | 15 | 13 | 15 |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ABDOMINAL RIGIDITY | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA | Systematic Assessment |
|
| VESSEL PUNCTURE SITE BRUISE | General disorders | MedDRA | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| OTITIS EXTERNA | Infections and infestations | MedDRA | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| NAIL INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| PERIORBITAL CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| BODY TEMPERATURE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| XANTHOMA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |