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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005412-25 | EudraCT Number |
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Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secukinumab 150mg | Experimental | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. |
|
| secukinumab 300 mg | Experimental | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. |
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| Placebo | Placebo Comparator | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were administered by sub-cutaneous injections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| secukinumab 150 mg | Biological | Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). |
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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 | Birmingham | Alabama | 35205 | United States | ||
| 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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Patients who completed Period 2 & patients who prematurely discontinued treatment or withdrew from study entered the treatment-free Follow-up (FU) Period (no study treatment was administered during Period) included only 1 visit at Week 140 (End of FU), which was 8 weeks after the end of Period 2 & 12 weeks after the last dose of study drug.
Week 16 was considered the first dose of Treatment Period 2. Week 132 visit was the final visit of Treatment Period 2, and no study treatment was administered at this visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 150mg | AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks |
| FG001 | AIN457 300 mg | AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Baseline to Week 16) |
|
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| secukinumab 300 mg | Biological | Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. |
|
|
| Placebo | Biological | Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. |
|
| Week 1, week 2, week 4, week, 8, week 12, week 16 |
| Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). | Week 16, Week 20, Week 28, Week 32, Week 64, Week 132 |
| Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). | Week 16, Week 24, Week 28, Week 80 |
| Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). | Week 16, Week 32, Week 80, Week 132 |
| Number of Participants Developing Anti-secukinumab Antibodies | To investigate the development of immunogenicity against secukinumab | Over time up to week 132 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40291 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02111 | United States |
| Novartis Investigative Site | Verona | New Jersey | 07044 | United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Goodlettsville | Tennessee | 37072-2301 | United States |
| Novartis Investigative Site | Sydney | New South Wales | 2010 | Australia |
| Novartis Investigative Site | Woolloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Carlton | Victoria | 3053 | Australia |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Calgary | Alberta | T2S 3B3 | Canada |
| Novartis Investigative Site | Barrie | Ontario | L4M 6L2 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 3H7 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3Z 2S6 | Canada |
| Novartis Investigative Site | Helsinki | 00250 HUS | Finland |
| Novartis Investigative Site | Tampere | 33100 | Finland |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Miskolc | 3529 | Hungary |
| Novartis Investigative Site | Szeged | H-6725 | Hungary |
| Novartis Investigative Site | Afula | 1834111 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Tel Aviv | 6209804 | Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
| Novartis Investigative Site | Breda | CK | 4818 | Netherlands |
| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Stavanger | 4068 | Norway |
| Novartis Investigative Site | Coimbra | 3000-075 | Portugal |
| Novartis Investigative Site | Lisbon | 1649-035 | Portugal |
| Novartis Investigative Site | Lisbon | 1998 - 018 | Portugal |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Porto | 4200 319 | Portugal |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Moscow | 107076 | Russia |
| Novartis Investigative Site | Moscow | 119071 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Kosice-Saca | Slovak Republic | 040 15 | Slovakia |
| Novartis Investigative Site | Košice | 04011 | Slovakia |
| Novartis Investigative Site | Svidník | 089 01 | Slovakia |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Las Palmas de Gran Canaria | Las Palmas de G.C | 35010 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Fatih / Istanbul | Turkey | 34093 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Gaziantep | 27310 | Turkey (Türkiye) |
| Novartis Investigative Site | London | England | E11 1NR | United Kingdom |
| Novartis Investigative Site | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| FG002 | Placebo - AIN457 150 mg | all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization |
| FG003 | Placebo - AIN457 300mg | all placebo patients who were re-randomized to AIN457 300 mg at re-randomization |
| FG004 | Placebo | placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. |
| FG005 | Any AIN457 Dose | All patients who were injected with AIN457 |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 (Week 16 to Week 132) |
|
|
| Follow-up Period (Week 132 to Week 140) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 150mg | AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks |
| BG001 | AIN457 300 mg | AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks |
| BG002 | Placebo | placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. |
| BG003 | 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 |
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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 | Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment | palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline. | Full Analysis Set (FAS): The FAS comprised of all patients from the randomized set to who study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. | Posted | Number | Percentages of participants | Week 16 |
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| Secondary | Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). | FAS | Posted | Number | Percentages of participants | Week 1, week 2, week 4, week, 8, week 12, week 16 |
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| Secondary | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). | FAS | Posted | Number | Percentages of participants | Week 16, Week 20, Week 28, Week 32, Week 64, Week 132 |
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| Secondary | Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period | ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline). | FAS | Posted | Number | Percentages of participants | Week 16, Week 24, Week 28, Week 80 |
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| Secondary | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). | FAS | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). | FAS | Posted | Mean | Standard Deviation | Units on a scale | Week 16, Week 32, Week 80, Week 132 |
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| Secondary | Number of Participants Developing Anti-secukinumab Antibodies | To investigate the development of immunogenicity against secukinumab | FAS | Posted | Count of Participants | Participants | Over time up to week 132 |
|
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 treatment until Last Patient Last Visit.
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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 | Any AIN457 150 mg | AIN457 150mg subcutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks | 19 | 99 | 75 | 99 | ||
| EG001 | Any AIN457 300 mg | AIN457 300mg subcutaneous ((2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks | 13 | 100 | 68 | 100 | ||
| EG002 | Placebo | placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks. | 2 | 68 | 30 | 68 | ||
| EG003 | Any AIN457 Dose | All patients who were injected with AIN457 | 32 | 199 | 143 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cellulitis of male external genital organ | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Infective keratitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Miscarriage of partner | Social circumstances | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D011537 | Pruritus |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| study terminated by sponsor |
|
| Withdrawal by Subject |
|
| non-compliance with study treatment |
|
| Death |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Male |
|
Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).
| Cochran-Mantel-Haenszel |
| <0.0001 |
| Odds Ratio (OR) |
| 29.4 |
| 2-Sided |
| 95 |
| 4.1 |
| 211.9 |
| Superiority or Other |
|
|
| OG003 | Placebo - AIN457 300 mg | all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization. |
| OG004 | Placebo | Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks |
|
|
| OG003 | Placebo - AIN457 300 mg | all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization. |
| OG004 | Placebo | Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks |
|
|
|
|
| OG004 | Placebo | Placebo AIN457 (2sc injections) once weekly for 5 weeks followed by dosing every 4 weeks |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|