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Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016. |
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| Measure | Description | Time Frame |
|---|---|---|
| proSPI (s) at Week 16 Compared to Baseline | The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study. | Week 0 (baseline) to 16 weeks |
| Changes of saSPI (s) at Week 16 Compared to Baseline | The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition | Week 0 (baseline) to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PASI (Psoriasis Area Severity Index) Score | PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease) | week 0, 16, 52 |
| Correlation Between PASI and proSPI (s) | Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PHILIPPE CELERIER | HOPITAL SAINT LOUIS - LA ROCHELLE | Principal Investigator |
| MARIE-ALETH RICHARD | HOPITAL TIMONES - MARSEILLE | Principal Investigator |
| SELIM ARACTINGI | HOPITAL COCHIN - PARIS | Principal Investigator |
| PIERRE ANDRE BECHEREL | HOPITAL PRIVE D'ANTONY - ANTONY | Principal Investigator |
| EMMANUEL MAHE | CH VICTOR DUPOUY - ARGENTEUIL | Principal Investigator |
| PHILIPPE LACOUR | HOPITAL L'ARCHET - NICE | Principal Investigator |
| MIREILLE RUER MULARD | CABINET BATEAU BLANC - MARTIGUES | Principal Investigator |
| THIERRY BOYE | HIA SAINTE ANNE - TOULON | Principal Investigator |
| ANNE DUVAL-MODESTE | HOPITAL CHARLES NICOLLE - ROUEN | Principal Investigator |
| MARIE BEYLOT-BARRY |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Le Mans | Cedex 09 | 72037 | France | ||
| 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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No significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to the treatment arm
Study centers: This study involved 17 active centers who enrolled (or recruited) patients in France
First patient enrolled: 20-May-2015
Last patient completed: 09-Feb-2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Secukinumab | Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit. |
| 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 | Mar 22, 2016 | Dec 7, 2018 |
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This was an open label single-arm study; therefore treatment blinding was not necessary.
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| week 0, 16, 52 |
| proSPI (s, p and i) Over Time | Professional Version of Simplified Psoriasis Index (proSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
| weeks 0, 16, 52 |
| saSPI (s, p and i) Over Time | Self-administered Simplified Psoriasis Index (saSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
| weeks 0, 16, 52 |
| DLQI (Dermatology Life Quality Index) Over Time | DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life | weeks 0, 16, 52 |
| Self-administered PASI (SA-PASI) | self-administered PASI (SA-PASI) score | weeks 0, 16, 52 |
| Psoriasis Symptom Diary (PSD) Score | assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling | weeks 0, 16, 52 |
| Correlation Between proSPI (for Each Component: s, p and i) and DLQI | Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below | weeks 0, 16, 52 |
| Correlation Between proSPI (for Components p and i) and PASI | Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below | Over time (from Week 0 to Week 52) |
| HOPITAL SAINT ANDRE - BORDEAUX |
| Principal Investigator |
| LAURENT MISERY | HOPITAL MORVAN - BREST | Principal Investigator |
| VINCENT DESCAMPS | HOPITAL BICHAT CLAUDE BERNARD - PARIS | Principal Investigator |
| GUILLAUME CHABY | CHU AMIENS NORD - AMIENS | Principal Investigator |
| CARLE PAUL | HOPITAL LARREY - TOULOUSE | Principal Investigator |
| CHRISTOPHE BEDANE | HOPITAL DUPUYTREN - LIMOGES | Principal Investigator |
| HERVÉ MAILLARD | CENTRE HOSPITALIER LE MANS - LE MANS | Principal Investigator |
| JEAN-FRANCOIS CUNY | HIA LEGOUEST - METZ | Principal Investigator |
| Limoges |
| Haute Vienne |
| 87000 |
| France |
| Novartis Investigative Site | Toulon | Val De Marne | 83800 | France |
| Novartis Investigative Site | Amiens | 80054 | France |
| Novartis Investigative Site | Antony | 92160 | France |
| Novartis Investigative Site | Argenteuil | 95107 | France |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Brest | 29609 | France |
| Novartis Investigative Site | La Rochelle | 17019 | France |
| Novartis Investigative Site | Marseille | 13885 | France |
| Novartis Investigative Site | Martigues | 13500 | France |
| Novartis Investigative Site | Metz | 57077 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Paris | 75014 | France |
| Novartis Investigative Site | Paris | 75877 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Toulouse | 31400 | France |
| COMPLETED |
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| NOT COMPLETED |
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FAS
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Secukinumab | Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||||
| proSPI (s) | proSPI (s) score range is 0 to 50. Higher score means worse condition | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| saSPI (s) | Mean | Standard Deviation | score on a scale for each domain of SPI |
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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 | proSPI (s) at Week 16 Compared to Baseline | The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study. | The primary analysis was performed on the FAS. To assess for robustness of the results, the primary analysis was repeated for the FAS (on observed data). | Posted | Mean | Standard Deviation | scores on a scale | Week 0 (baseline) to 16 weeks |
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| Secondary | PASI (Psoriasis Area Severity Index) Score | PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease) | Full Analysis Set (observed) | Posted | Mean | Standard Deviation | scores on a scale | week 0, 16, 52 |
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| Secondary | Correlation Between PASI and proSPI (s) | Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score | Full Analysis Set (observed) | Posted | Number | 95% Confidence Interval | Spearman Correlation coefficient | week 0, 16, 52 |
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| Secondary | proSPI (s, p and i) Over Time | Professional Version of Simplified Psoriasis Index (proSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
| Full Analysis Set (observed) | Posted | Mean | Standard Deviation | scores on a scale | weeks 0, 16, 52 |
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| Secondary | saSPI (s, p and i) Over Time | Self-administered Simplified Psoriasis Index (saSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
| Full Analysis Set (observed) | Posted | Mean | Standard Deviation | saSPI score | weeks 0, 16, 52 |
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| Secondary | DLQI (Dermatology Life Quality Index) Over Time | DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life | Full Analysis Set (observed) | Posted | Mean | Standard Deviation | DLQI score (range : 0 - 30) | weeks 0, 16, 52 |
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| Secondary | Self-administered PASI (SA-PASI) | self-administered PASI (SA-PASI) score | Full Analysis Set (observed) | Posted | Mean | Standard Deviation | saPASI score (range: 0 to 72) | weeks 0, 16, 52 |
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| Secondary | Psoriasis Symptom Diary (PSD) Score | assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling | Full Analysis Set (observed) | Posted | Mean | Standard Deviation | scores on a scale | weeks 0, 16, 52 |
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| Secondary | Correlation Between proSPI (for Each Component: s, p and i) and DLQI | Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below | Full Analysis Set (observed) | Posted | Number | 95% Confidence Interval | Spearman correlation coefficient | weeks 0, 16, 52 |
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| Secondary | Correlation Between proSPI (for Components p and i) and PASI | Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below | Full Analysis Set (observed) | Posted | Number | 95% Confidence Interval | Spearman correlation coefficient | Over time (from Week 0 to Week 52) |
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| Primary | Changes of saSPI (s) at Week 16 Compared to Baseline | The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition | Full Analysis Set (FAS): The FAS comprised all patients from the IS who were administered at least one dose of investigational drug with at least one Baseline and one post-baseline SPI evaluation. | Posted | Mean | Standard Deviation | scores on a scale | Week 0 (baseline) to 16 weeks |
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baseline to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIN457 300mg | Listed below are the most frequent treatment emergent adverse events irrespective of causality | 2 | 120 | 13 | 120 | 86 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Face oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
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| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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The two deaths (i.e.; head injury and lymphoma) were not related to the study treatment
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 | +1(862)778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2017 | Dec 7, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| D012008 | Recurrence |
| D058225 | Plaque, Amyloid |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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| WO |
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| W16 |
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| W52 |
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