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This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.
This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).
During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.
K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Eligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48 |
|
| Placebo | Placebo Comparator | Eligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 | Response in skin histology/K16 expression to treatment (answered no) | 12 weeks |
| Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12 | Psoriasis Area and Severity Index 90 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52 | Response in skin histology/K16 expression to treatment (answered no) | 52 weeks |
| Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52 |
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Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed
Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
Moderate to severe plaque psoriasis as defined at baseline by:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Study Lead Novartis Pharmaceuticals | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hot Springs | Arkansas | 71913 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41774505 | Derived | Shishido-Takahashi N, Garcet S, Cueto I, Hur HB, Muscianisi E, Steadman J, Blauvelt A, Krueger JG. Cutaneous adipose tissue carries a strong inflammatory signature in patients with psoriasis. JCI Insight. 2026 Mar 3;11(7):e194171. doi: 10.1172/jci.insight.194171. eCollection 2026 Apr 8. |
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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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This is The Randomized Set; i.e., all randomized participants
A total of 133 patients were screened for the study, with 82 (61.7%) of these completing the screening phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 300 mg | Participants received secukinumab 300 mg s.c. at randomization |
| FG001 | Placebo/Secukinumab 300 mg | Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12 |
| 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 | Feb 23, 2018 | Feb 25, 2020 |
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| Placebo | Biological | Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48 |
|
Psoriasis Area and Severity Index 90 |
| 52 weeks |
| Change in Systolic Blood Pressure From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in Diastolic Blood Pressure From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in Body Weight From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in Glucose Level From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in Insulin Level From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | baseline, Week 12 |
| Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. | baseline, Week 12 |
| Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to week 12 For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes. | baseline, week 12 |
| Los Angeles |
| California |
| 90033 |
| United States |
| Novartis Investigative Site | Santa Ana | California | 92701 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | East Windsor | New Jersey | 08520 | United States |
| Novartis Investigative Site | West Orange | New Jersey | 07052 | United States |
| Novartis Investigative Site | Buffalo | New York | 14203 | United States |
| Novartis Investigative Site | New York | New York | 10025 1737 | United States |
| Novartis Investigative Site | New York | New York | 10065 | United States |
| Novartis Investigative Site | Portland | Oregon | 97223 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15213-3403 | United States |
| Novartis Investigative Site | Webster | Texas | 77004 | United States |
| Novartis Investigative Site | Murray | Utah | 84107 | United States |
| Novartis Investigative Site | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 300 mg | Participants received secukinumab 300 mg s.c. at randomization |
| BG001 | Placebo | Participants received placebo at randomization |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of participants | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | 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 | Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 | Response in skin histology/K16 expression to treatment (answered no) | Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization. | Posted | Count of Participants | Participants | 12 weeks |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12 | Psoriasis Area and Severity Index 90 | Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization. | Posted | Count of Participants | Participants | 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52 | Response in skin histology/K16 expression to treatment (answered no) | Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization. | Posted | Count of Participants | Participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52 | Psoriasis Area and Severity Index 90 | FAS | Posted | Count of Participants | Participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | mmHg | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | mmHg | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | kg | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Glucose Level From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | mmol/L | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Insulin Level From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | pmol/L | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | mg/L | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to Week 12 Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | SI units | baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12 | Vital signs: summary statistics for change from baseline to week 12 For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes. | Safety Set The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received. | Posted | Mean | Standard Deviation | scores | baseline, week 12 |
|
|
Up to 52 weeks
An adverse event (AE) is any sign or symptom that occurs during the study treatment
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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 | Secukinumab 300 mg | Secukinumab 300 mg | 0 | 54 | 1 | 54 | 39 | 54 |
| EG001 | Placebo/Secukinumab 300 mg | Participants received placebo at randomization and were started on secukinumab 300 mg at Week 12 | 0 | 28 | 1 | 28 | 25 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Eye infection bacterial | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Otitis externa candida | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Dysplastic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Testicular oedema | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
Change in Body Mass Index (BMI) was not measured
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 publication of the pooled data (i.e., 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 | May 9, 2019 | Feb 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Male |
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| Unknown |
|
| Caucasian |
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| Black |
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| Asian |
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| Other |
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