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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000985-39 | EudraCT Number |
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CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 150 mg - Fixed Interval (FI) | Experimental | 1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks |
|
| AIN457 150 mg - Start of relapse (SoR) | Experimental | Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks |
|
| AIN457 300 mg - Fixed Interval (FI) | Experimental | 2 s.c. Secukinumab 150 mg PFS injections every 4 weeks |
|
| AIN457 300 mg - Start of Relapse (SoR) | Experimental | Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks |
|
| AIN457 300 mg - Open Label (OL) | Experimental | Open Label - Secukinumab 300mg every 4 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 150 mg | Drug | (1 injection per dose) and placebo to Secukinumab 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety and Tolerability of Secukinumab | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) | Week 268 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) |
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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 | Fresno | California | 93710 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28580579 | Derived | Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4. |
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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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At Week 156, subjects who rolled over from the CAIN457A2304 study were unblinded and provided an option to switch to one of the treatment options described below upon investigator judgment; subjects from the CAIN457A2307 study could administer study drug at home every 4 weeks, but were required to come for office visits every 12-16 weeks.
675 subjects from the core studies (CAIN457A2304 and CAIN457A2307) were enrolled at 112 sites. Subjects enrolled in the secukinumab 300 mg Open-Label (OL) arm came only from the CAIN457A2307 study, as such they were partial responders at Week 12, while all other subjects in the extension were PASI 75 responders at Week 12 in the core study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN150FI | AIN457 150 mg - Fixed Interval (FI) |
| FG001 | AIN150 FI_AIN300 FI | AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW) |
| 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 29, 2015 | Apr 23, 2018 |
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|
| AIN457 300 mg | Drug | Secukinumab 150 mg (2 injections per dose) |
|
|
| Placebo | Drug |
|
| Week 52, Week 104, Week 156, Week 208, Week 260 |
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) | Week 52, Week 104, Week 156, Week 208, Week 260 |
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) | Baseline, Week 52, Week 104, Week 156, Week 208, Week 260 |
| Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 | The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe. | Week 52, Week 104, Week 156, Week 208, Week 260 |
| Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions | Baseline, Week 52, Week 104, Week 156, Week 208, Week 260 |
| Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions | Week 52, Week 104, Week 156, Week 208, Week 260 |
| EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156 | ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state) | Baseline, Week 52, Week 104, Week 156 |
| Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA) | The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. | Week 268 |
| Percentage of Patients With Experiencing a Relapse | Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement. | Week 260 |
| Percentage of Patients With Experiencing a Rebound | Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event). PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement. | Up to Week 264 (8 weeks post last dose) |
| Pasadena |
| California |
| 91105 |
| United States |
| Novartis Investigative Site | San Francisco | California | 94118 | United States |
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| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
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| Novartis Investigative Site | Salt Lake City | Utah | 84124 | United States |
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| Novartis Investigative Site | Barrie | Ontario | L4M 6L2 | Canada |
| Novartis Investigative Site | Oakville | Ontario | L6J 7W5 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Windsor | Ontario | N8W 1E6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2K 4L5 | Canada |
| Novartis Investigative Site | Brno-Bohunice | Czech Republic | 625 00 | Czechia |
| Novartis Investigative Site | Hradec Králové | CZE | 500 05 | Czechia |
| Novartis Investigative Site | Prague | CZE | 180 81 | Czechia |
| Novartis Investigative Site | České Budějovice | 370 01 | Czechia |
| Novartis Investigative Site | Nový Jičín | 741 01 | Czechia |
| Novartis Investigative Site | Prague | 100 34 | Czechia |
| Novartis Investigative Site | Antony | 92160 | France |
| Novartis Investigative Site | Nice | 06202 | France |
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| Novartis Investigative Site | Rouen | 76031 | France |
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| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| Novartis Investigative Site | Bochum | 44793 | Germany |
| Novartis Investigative Site | Buchholz I. D. Nordheide | 21244 | Germany |
| Novartis Investigative Site | Dippoldiswalde-Schmiedeberg | 01744 | Germany |
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| Novartis Investigative Site | Hamburg | 20246 | Germany |
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| Novartis Investigative Site | Roma | RM | 00133 | Italy |
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| Novartis Investigative Site | Siena | SI | 53100 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan |
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| Novartis Investigative Site | Fukuoka | Fukuoka | 815-8588 | Japan |
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| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160-0023 | Japan |
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| Novartis Investigative Site | Lodz | 90-265 | Poland |
| Novartis Investigative Site | Poznan | 60 529 | Poland |
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| Novartis Investigative Site | Singapore | 119074 | Singapore |
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| Novartis Investigative Site | Košice | Slovak Republic | 040 15 | Slovakia |
| Novartis Investigative Site | Košice | 04011 | Slovakia |
| Novartis Investigative Site | Poprad | 05845 | Slovakia |
| Novartis Investigative Site | Svidník | 089 01 | Slovakia |
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| Novartis Investigative Site | Bern | 3010 | Switzerland |
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| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2WB | United Kingdom |
| Novartis Investigative Site | Blackpool | FY3 7EN | United Kingdom |
| Novartis Investigative Site | Leicester | LE7 5WW | United Kingdom |
| Novartis Investigative Site | Poole | BH15 2JB | United Kingdom |
| Novartis Investigative Site | Ho Chi Minh City | VNM | 700000 | Vietnam |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Novartis Investigative Site | Hanoi | 1000 | Vietnam |
| Novartis Investigative Site | Ho Chi Minh City | 7000 | Vietnam |
| FG002 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| FG003 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| FG004 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| FG005 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| FG006 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| FG007 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIN150FI | AIN457 150 mg - Fixed Interval (FI) |
| BG001 | AIN150 FI_AIN300 FI | AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW) |
| BG002 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| BG003 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| BG004 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| BG005 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| BG006 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| BG007 | AIN300 OL | AIN457 300 mg Open-label (OL) |
| BG008 | 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 (NIH/OMB) | Count of Participants | 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 | Long-term Safety and Tolerability of Secukinumab | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) | Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done. | Posted | Number | Percentage of participants | Week 268 |
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| Secondary | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 | The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe. | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Median | 95% Confidence Interval | Percent change | Baseline, Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 | The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | Percentage of participants | Week 52, Week 104, Week 156, Week 208, Week 260 |
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| Secondary | EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156 | ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state) | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 52, Week 104, Week 156 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA) | The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done. | Posted | Number | Participants | Week 268 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Experiencing a Relapse | Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement. | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Week 260 |
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| Secondary | Percentage of Patients With Experiencing a Rebound | Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event). PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement. | The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 264 (8 weeks post last dose) |
|
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 4 years and 7 months.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Not provided
| 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 | Any AIN457 150 mg | 0 | 132 | 25 | 132 | 93 | 132 |
| EG001 | Any AIN457 300 mg | Any AIN457 300 mg | 4 | 543 | 119 | 543 | 449 | 543 |
| EG002 | Any AIN457 Dose | Any AIN457 dose | 4 | 675 | 144 | 675 | 542 | 675 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LYMPHOID TISSUE HYPERPLASIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| AORTIC VALVE DISEASE | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BUNDLE BRANCH BLOCK LEFT | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CONGESTIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CORONARY OSTIAL STENOSIS | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LONG QT SYNDROME | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MYOCARDITIS | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ANAL INCONTINENCE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LEUKOPLAKIA ORAL | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATITIS ALCOHOLIC | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACUTE HEPATITIS B | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| BURSITIS INFECTIVE STAPHYLOCOCCAL | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CHRONIC TONSILLITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| MENINGITIS STREPTOCOCCAL | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| OSTEOMYELITIS BACTERIAL | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| PERITONSILLITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| BRAIN CONTUSION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| LIGAMENT INJURY | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| LIMB CRUSHING INJURY | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| SPLENIC INJURY | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| LIVER FUNCTION TEST INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| BENIGN LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| BLADDER ADENOCARCINOMA STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| DYSPLASTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| ENDOMETRIAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CAUDA EQUINA SYNDROME | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CERVICOBRACHIAL SYNDROME | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| CUBITAL TUNNEL SYNDROME | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| NERVE COMPRESSION | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PERONEAL NERVE PALSY | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DEVICE MALFUNCTION | Product Issues | MedDRA (20.0) | Systematic Assessment |
| |
| ADJUSTMENT DISORDER | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| RENAL INFARCT | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| RENAL INJURY | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| RENAL TUBULAR NECROSIS | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MENOMETRORRHAGIA | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| VULVA CYST | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PULMONARY CAVITATION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| RESPIRATORY SYMPTOM | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| THORACIC HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ALCOHOL USE | Social circumstances | MedDRA (20.0) | Systematic Assessment |
| |
| AORTIC DILATATION | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TACHYCARDIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| FURUNCLE | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| TINEA PEDIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (20.0) | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2018 | Apr 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D058225 | Plaque, Amyloid |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| SAEs by Primary System Organ Class (SOC) |
|
| Deaths by Primary System Organ Class (SOC) |
|
AIN457 150 mg - Fixed Interval combined non-switch and switch
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
AIN457 150 mg - Fixed Interval combined non-switch and switch
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
AIN457 150 mg - Fixed Interval combined non-switch and switch
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
| AIN300 FI |
AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
| OG003 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG004 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG005 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG006 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG007 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG008 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)
| OG005 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG006 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG007 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
AIN457 300 mg - Fixed Interval (FI)
| OG003 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG004 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG005 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG006 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG007 | AIN300 OL | AIN457 300 mg Open-label (OL) |
|
|
AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)
| OG002 | AIN300 FI | AIN457 300 mg - Fixed Interval (FI) |
| OG003 | AIN150 SoR | AIN457 150 mg - Start of Relapse (SoR) |
| OG004 | AIN150 SOR_AIN300 FI | AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW) |
| OG005 | AIN300 SoR | AIN457 300 mg - Start of Relapse (SoR) |
| OG006 | AIN300 SoR _ AIN300 FI | AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW) |
| OG007 | AIN300 OL | AIN457 300 mg Open-label (OL) |
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