A Phase 4 interventional study of Secukinumab and Life-style intervention in Psoriasis and Metabolic Syndrome, sponsored by Novartis Pharmaceuticals. Completed at 75 sites in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment
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Among 68 studies in Psoriasis by Novartis — 3 open to participants now, 4 under way, none of them phase 3. Psoriasis · Novartis.
Among the 68 studies in Psoriasis by Novartis, this one is the 6th largest by enrollment of the 53 interventional ones that give a count, is one of 3 that started in 2018, is one of 6 in phase 4, and was the 48th registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →3 of the 68 studies in Psoriasis by Novartis are open now, in 3 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–100
Novartis Pharmaceuticals · Sites in Spain
Ages 18–100
Novartis Pharmaceuticals · Sites in Canada
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 30 · Phase 4 6
First in 2004; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 781 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 177 across the 53 interventional studies, 255 across the 14 observational. Of the 61 that completed or were terminated, 41 (67%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
3 of the studies in Psoriasis by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06382051Novartis PharmaceuticalsModifying PEST for Psoriatic Arthritis Screening | 2026-12-31 |
| NCT07683065Novartis PharmaceuticalsA Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD | 2027-01-15 |
| NCT06142357Novartis PharmaceuticalsSecukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis | 2027-08-31 |
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Among the 68 studies in Psoriasis by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.
This study included Core study with a duration of 28 weeks followed by an Extension period (exploratory period) with a duration of 28 weeks.
Core study:
After providing informed consent, patients were screened for eligibility for a period of 1 to 4 weeks prior to inclusion in the study. Eligible patients were randomized to one of the two treatment arms, which were the following:
A biomarker sub-study was conducted during the core study in a subgroup of 100 patients (50 from each treatment arm).
The core study ended at Week 28.
Extension period (exploratory period):
After 28 weeks, the study continued with an extension period, during which lifestyle intervention was offered to all patients, irrespective of their prior treatment arm. This meant that patients of arm B, who were willing to, could continue their previously started lifestyle intervention program, and patients of arm A, who were willing to, could start the lifestyle intervention program at the beginning of the extension period. All patients, irrespective of their decision whether to start/continue lifestyle intervention or not, had to participate in the extension period and visit their dermatologic study center for scheduled visits. The extension period ended at Week 56, where all patients completed the study. No study drug was supplied during the extension period. The treating physician could choose psoriasis therapy freely according to their discretion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with moderate to severe plaque-type psoriasis who are candidates for systemic therapy, diagnosed at least 6 month before randomization and baseline value of
Fulfillment of Metabolic Syndrome definition (Alberti et al., 2009), which means fulfillment of ≥3 of the following criteria at screening visit:
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
Patients with diagnosed type 2 diabetes, if they fulfill one or more of the following conditions:
Women of , defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of during dosing of investigational drug for at least 20 weeks after the end of Secukinumab treatment. Basic contraception methods include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).
Drug: Secukinumab
Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Drug: Secukinumab · Behavioral: Life-style intervention
Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24)
A structured program to guide weight loss and increased physical activity
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 90 represents patients achieving \>= 90% improvement (reduction) in PASI score compared to Baseline. Patients with missing PASI at Week 28 were counted as non-responders.
Time frame: Baseline, Week 28
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 75 represents patients achieving \>= 75% improvement (reduction) in PASI score compared to Baseline.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 90 represents patients achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 100 response/remission represents patients achieving complete clearing of psoriasis (PASI = 0) compared to Baseline.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time
The Psoriasis Area and Severity Index (PASI) combines lesion severity and the extent of affected area into a single score ranging from 0 (no disease) to 72 (maximum disease). The body is divided into four regions for scoring: head, trunk, upper limbs, and lower limbs. Each region is scored individually, and these scores are then combined to calculate the final PASI. For each region, the percentage of skin involved is estimated on a scale from 0 (0%) to 6 (90-100%), and severity is assessed based on clinical signs such as erythema, induration, and desquamation, on a scale from 0 (none) to 4 (maximum). The final PASI is the sum of the severity parameters for each area multiplied by the area score weight of the section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change in the absolute PASI score indicates a reduction in psoriasis severity, signifying an improvement in the patient's condition.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
High-sensitivity C-reactive Protein (hsCRP) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 28
Mean Change From Baseline in Fructosamine
Fructosamine was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Fasting Plasma Glucose (FPG)
Fasting Plasma Glucose (FPG) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 28
Mean Change From Baseline in Total Cholesterol
Total cholesterol was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 28
Mean Change From Baseline in Low-Density Lipoprotein (LDL)
Low-Density Lipoprotein (LDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 28
Mean Change From Baseline in High-Density Lipoprotein (HDL)
High-Density Lipoprotein (HDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 28
Mean Change From Baseline in Triglycerides
Triglycerides were evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 8, Week 16, Week 28
Mean Change From Baseline in Waist Circumference
Waist circumference was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Body Weight
Body weight was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Body Mass Index (BMI)
Body Mass Index (BMI) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Systolic Blood Pressure (SBP)
Systolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Dermatology Life Quality Index (DLQI) Total Score Over Time
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient's life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient's life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response
All patients with DLQI score 0 and 1 were considered as responders and patients with DLQI score \>=2 were considered as non-responders. Subjects with missing DLQI score were counted as non-responders.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
World Health Organization Well-Being Index (WHO-5) Total Score Over Time
The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 ("the whole time") to 0 ("at no time point"). The WHO-5 total score is the sum of the 5 questions and ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time
The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 ("the whole time") to 0 ("at no time point"). The WHO-5 total score is the sum of the 5 questions and ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Participant's Self-assessed Pain, Itching and Scaling Over Time
A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject's assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling
A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject's assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
This study was conducted at 81 centers in Germany.
| Milestone | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Extension Period: Lifestyle Intervention | Extension Period: Lifestyle Intervention + Secukinumab | Extension Period: Secukinumab |
|---|---|---|---|---|---|
| Started | 371 | 410 | 0 | 0 | 0 |
| Full analysis set (fas) | 371 | 409 | 0 | 0 | 0 |
| Safety set (saf) | 371 | 409 | 0 | 0 | 0 |
| Completed | 342 | 375 | 0 | 0 | 0 |
| Not completed | 29 | 35 | 0 | 0 | 0 |
| Withdrew: Adverse event | 8 | 7 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 3 | 0 | 0 | 0 |
| Withdrew: Non-compliance with study treatment | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 4 | 4 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 8 | 0 | 0 | 0 |
| Withdrew: Physician decision | 2 | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 9 | 10 | 0 | 0 | 0 |
| Withdrew: Subject discontinued the study due to emergency | 1 | 0 | 0 | 0 | 0 |
| Milestone | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Extension Period: Lifestyle Intervention | Extension Period: Lifestyle Intervention + Secukinumab | Extension Period: Secukinumab |
|---|---|---|---|---|---|
| Started | 0 | 0 | 189 | 164 | 347 |
| Continued lifestyle intervention in extension period | 0 | 0 | 119 | 109 | 0 |
| Initiated lifestyle intervention in extension period | 0 | 0 | 70 | 55 | 0 |
| Secukinumab given as concomitant medication during extension period | 0 | 0 | 0 | 162 | 157 |
| Completed | 0 | 0 | 182 | 160 | 347 |
| Not completed | 0 | 0 | 7 | 4 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Subject/guardian decision | 0 | 0 | 6 | 2 | 0 |
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 90 represents patients achieving \>= 90% improvement (reduction) in PASI score compared to Baseline. Patients with missing PASI at Week 28 were counted as non-responders.
| Participants | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28 | 219 | 261 |
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 75 represents patients achieving \>= 75% improvement (reduction) in PASI score compared to Baseline.
| Participants | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 1 | 2 | 1 |
| Week 2 | 11 | 3 |
| Week 3 | 50 | 56 |
| Week 4 | 108 | 135 |
| Week 8 | 239 | 265 |
| Week 12 | 241 | 276 |
| Week 16 | 287 | 332 |
| Week 20 | 290 | 333 |
| Week 24 | 285 | 333 |
| Week 28 | 286 | 335 |
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 90 represents patients achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline.
| Participants | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 2 | 0 |
| Week 3 | 7 | 4 |
| Week 4 | 25 | 30 |
| Week 8 | 130 | 141 |
| Week 12 | 159 | 182 |
| Week 16 | 215 | 241 |
| Week 20 | 217 | 242 |
| Week 24 | 224 | 251 |
The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); 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). PASI 100 response/remission represents patients achieving complete clearing of psoriasis (PASI = 0) compared to Baseline.
| Participants | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 1 | 0 |
| Week 3 | 1 | 0 |
| Week 4 | 5 | 4 |
| Week 8 | 35 | 39 |
| Week 12 | 48 | 71 |
| Week 16 | 82 | 115 |
| Week 20 | 100 | 108 |
| Week 24 | 101 | 115 |
| Week 28 | 105 | 118 |
The Psoriasis Area and Severity Index (PASI) combines lesion severity and the extent of affected area into a single score ranging from 0 (no disease) to 72 (maximum disease). The body is divided into four regions for scoring: head, trunk, upper limbs, and lower limbs. Each region is scored individually, and these scores are then combined to calculate the final PASI. For each region, the percentage of skin involved is estimated on a scale from 0 (0%) to 6 (90-100%), and severity is assessed based on clinical signs such as erythema, induration, and desquamation, on a scale from 0 (none) to 4 (maximum). The final PASI is the sum of the severity parameters for each area multiplied by the area score weight of the section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change in the absolute PASI score indicates a reduction in psoriasis severity, signifying an improvement in the patient's condition.
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 1 | -2.8 ± 0.22 | -2.9 ± 0.21 |
| Week 2 | -6.6 ± 0.23 | -6.9 ± 0.22 |
| Week 3 | -9.9 ± 0.25 | -10.1 ± 0.23 |
| Week 4 | -12.0 ± 0.26 | -12.4 ± 0.25 |
| Week 8 | -15.5 ± 0.26 | -15.5 ± 0.25 |
| Week 12 | -16.6 ± 0.26 | -16.9 ± 0.25 |
| Week 16 | -17.2 ± 0.27 | -17.3 ± 0.26 |
| Week 20 | -17.4 ± 0.27 | -17.5 ± 0.26 |
| Week 24 | -17.4 ± 0.28 | -17.6 ± 0.26 |
| Week 28 | -17.3 ± 0.29 | -17.6 ± 0.27 |
High-sensitivity C-reactive Protein (hsCRP) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram/litre (mg/L) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 2 | -0.087 ± 0.7242 | -0.124 ± 0.5178 |
| Change from BL @ Week 4 | -0.098 ± 0.6860 | -0.117 ± 0.5218 |
| Change from BL @ Week 8 | -0.117 ± 0.6797 | -0.092 ± 0.5733 |
| Change from BL @ Week 12 | -0.069 ± 0.7539 | -0.078 ± 0.7599 |
| Change from BL @ Week 16 | -0.100 ± 0.6654 | -0.116 ± 0.4679 |
| Change from BL @ Week 20 | -0.074 ± 0.7019 | -0.113 ± 0.5109 |
| Change from BL @ Week 24 | -0.087 ± 0.7964 | -0.097 ± 0.5783 |
| Change from BL @ Week 28 | -0.101 ± 0.7694 | -0.141 ± 0.4254 |
Hemoglobin A1c (HbA1c) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| Percentage (%) of HbA1c | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | 0.01 ± 0.293 | -0.07 ± 0.314 |
| Change from BL @ Week 16 | 0.03 ± 0.389 | -0.06 ± 0.342 |
| Change from BL @ Week 24 | 0.03 ± 0.388 | -0.04 ± 0.332 |
| Change from BL @ Week 28 | 0.03 ± 0.417 | -0.05 ± 0.353 |
Fructosamine was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| micromole/liter (µmol/L) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 4 | -1.0 ± 43.96 | -9.6 ± 43.23 |
| Change from BL @ Week 8 | -2.4 ± 41.24 | -4.2 ± 48.95 |
| Change from BL @ Week 12 | 6.6 ± 45.84 | -6.4 ± 39.15 |
| Change from BL @ Week 16 | 0.8 ± 45.17 | -0.4 ± 48.15 |
| Change from BL @ Week 20 | -0.6 ± 46.43 | -6.4 ± 56.76 |
| Change from BL @ Week 24 | 0.6 ± 44.51 | 3.9 ± 51.88 |
| Change from BL @ Week 28 | 2.3 ± 47.29 | 1.7 ± 48.00 |
Fasting Plasma Glucose (FPG) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram per deciliter (mg/dL) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | 0.8 ± 17.14 | -1.7 ± 16.71 |
| Change from BL @ Week 16 | 1.9 ± 20.51 | -2.1 ± 16.26 |
| Change from BL @ Week 28 | 2.9 ± 22.29 | -0.5 ± 18.60 |
Total cholesterol was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram per deciliter (mg/dL) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | 1.9 ± 26.75 | -2.5 ± 24.84 |
| Change from BL @ Week 16 | -0.2 ± 25.33 | -1.3 ± 25.30 |
| Change from BL @ Week 28 | -0.4 ± 30.13 | -3.1 ± 25.45 |
Low-Density Lipoprotein (LDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram per deciliter (mg/dL) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | 1.6 ± 21.53 | -2.2 ± 22.00 |
| Change from BL @ Week 16 | -1.4 ± 22.67 | -0.9 ± 24.14 |
| Change from BL @ Week 28 | 1.9 ± 25.57 | -1.2 ± 25.10 |
High-Density Lipoprotein (HDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram per deciliter (mg/dL) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | -0.5 ± 5.29 | -1.0 ± 6.20 |
| Change from BL @ Week 16 | -0.8 ± 5.92 | 0.0 ± 6.69 |
| Change from BL @ Week 28 | 0.0 ± 6.91 | 0.5 ± 7.29 |
Triglycerides were evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| milligram per deciliter (mg/dL) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 8 | 2.5 ± 100.55 | -2.7 ± 100.29 |
| Change from BL @ Week 16 | 11.0 ± 146.64 | -1.7 ± 111.36 |
| Change from BL @ Week 28 | -5.9 ± 187.93 | -6.3 ± 98.69 |
Waist circumference was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| Centimeter (cm) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 1 | -0.5 ± 2.97 | -0.3 ± 3.41 |
| Change from BL @ Week 2 | -0.7 ± 3.74 | -1.1 ± 4.30 |
| Change from BL @ Week 3 | -0.8 ± 3.66 | -1.3 ± 4.71 |
| Change from BL @ Week 4 | -0.9 ± 3.92 | -2.0 ± 4.54 |
| Change from BL @ Week 8 | -1.2 ± 4.53 | -2.6 ± 5.34 |
| Change from BL @ Week 12 | -1.1 ± 4.43 | -2.9 ± 5.68 |
| Change from BL @ Week 16 | -1.4 ± 5.22 | -3.5 ± 6.09 |
| Change from BL @ Week 20 | -1.3 ± 5.47 | -3.4 ± 7.00 |
| Change from BL @ Week 24 | -1.4 ± 5.34 | -3.7 ± 6.72 |
| Change from BL @ Week 28 | -1.5 ± 5.50 | -3.9 ± 7.04 |
Body weight was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| Kilogram (kg) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 1 | 0.06 ± 2.120 | -0.33 ± 1.401 |
| Change from BL @ Week 2 | -0.04 ± 1.729 | -0.75 ± 1.739 |
| Change from BL @ Week 3 | -0.05 ± 2.189 | -1.08 ± 2.278 |
| Change from BL @ Week 4 | -0.08 ± 2.326 | -1.20 ± 2.177 |
| Change from BL @ Week 8 | -0.15 ± 2.447 | -1.84 ± 3.471 |
| Change from BL @ Week 12 | 0.02 ± 2.726 | -2.38 ± 4.150 |
| Change from BL @ Week 16 | -0.21 ± 3.243 | -2.65 ± 4.891 |
| Change from BL @ Week 20 | -0.36 ± 3.581 | -2.72 ± 5.480 |
| Change from BL @ Week 24 | -0.30 ± 3.815 | -2.86 ± 6.056 |
| Change from BL @ Week 28 | -0.17 ± 3.803 | -3.03 ± 6.107 |
Body Mass Index (BMI) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| Kilogram by square meter (kg/m^2) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 1 | 0.015 ± 0.6846 | -0.110 ± 0.4515 |
| Change from BL @ Week 2 | -0.015 ± 0.5545 | -0.240 ± 0.5649 |
| Change from BL @ Week 3 | -0.014 ± 0.7076 | -0.346 ± 0.7352 |
| Change from BL @ Week 4 | -0.027 ± 0.7451 | -0.386 ± 0.7128 |
| Change from BL @ Week 8 | -0.047 ± 0.7838 | -0.582 ± 1.1641 |
| Change from BL @ Week 12 | 0.009 ± 0.8768 | -0.758 ± 1.3522 |
| Change from BL @ Week 16 | -0.070 ± 1.0432 | -0.843 ± 1.5780 |
| Change from BL @ Week 20 | -0.113 ± 1.1627 | -0.864 ± 1.7769 |
| Change from BL @ Week 24 | -0.094 ± 1.2417 | -0.906 ± 1.9591 |
| Change from BL @ Week 28 | -0.054 ± 1.2309 | -0.961 ± 1.9665 |
Systolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| millimeter of mercury (mmHg) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 1 | -0.66 ± 10.033 | -1.44 ± 10.964 |
| Change from BL @ Week 2 | -1.24 ± 11.499 | -3.12 ± 11.422 |
| Change from BL @ Week 3 | -1.05 ± 11.086 | -3.67 ± 12.740 |
| Change from BL @ Week 4 | -3.02 ± 10.693 | -4.33 ± 11.763 |
| Change from BL @ Week 8 | -2.52 ± 12.394 | -3.88 ± 12.545 |
| Change from BL @ Week 12 | -1.64 ± 12.054 | -3.65 ± 12.982 |
| Change from BL @ Week 16 | -3.03 ± 12.646 | -4.33 ± 12.980 |
| Change from BL @ Week 20 | -1.65 ± 12.067 | -3.70 ± 13.323 |
| Change from BL @ Week 24 | -2.53 ± 12.681 | -4.35 ± 13.455 |
| Change from BL @ Week 28 | -2.56 ± 12.179 | -4.28 ± 13.475 |
Diastolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.
| millimeter of mercury (mmHg) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 1 | -0.39 ± 6.761 | -1.02 ± 7.495 |
| Change from BL @ Week 2 | -0.65 ± 7.460 | -1.16 ± 7.630 |
| Change from BL @ Week 3 | -0.62 ± 7.180 | -1.66 ± 8.030 |
| Change from BL @ Week 4 | -1.29 ± 7.349 | -2.00 ± 7.925 |
| Change from BL @ Week 8 | -0.60 ± 7.510 | -1.51 ± 7.517 |
| Change from BL @ Week 12 | -0.37 ± 7.820 | -1.56 ± 8.754 |
| Change from BL @ Week 16 | -0.60 ± 7.969 | -1.99 ± 8.211 |
| Change from BL @ Week 20 | -0.59 ± 8.040 | -2.28 ± 8.275 |
| Change from BL @ Week 24 | -0.73 ± 8.270 | -2.04 ± 8.701 |
| Change from BL @ Week 28 | -0.48 ± 8.417 | -1.65 ± 8.877 |
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient's life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Baseline | 19.55 ± 5.124 | 19.12 ± 5.449 |
| Week 4 | 8.57 ± 5.932 | 7.92 ± 6.119 |
| Week 8 | 5.47 ± 5.725 | 5.18 ± 5.405 |
| Week 12 | 4.29 ± 5.341 | 4.16 ± 5.100 |
| Week 16 | 3.90 ± 5.374 | 3.73 ± 4.927 |
| Week 20 | 3.43 ± 5.101 | 3.43 ± 5.061 |
| Week 24 | 3.42 ± 5.261 | 3.33 ± 4.824 |
| Week 28 | 3.42 ± 5.242 | 3.30 ± 5.312 |
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient's life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Change from BL @ Week 4 | -11.0 ± 6.66 | -11.3 ± 6.68 |
| Change from BL @ Week 8 | -14.1 ± 6.91 | -14.1 ± 6.60 |
| Change from BL @ Week 12 | -15.5 ± 6.68 | -15.1 ± 6.51 |
| Change from BL @ Week 16 | -15.7 ± 6.60 | -15.4 ± 6.33 |
| Change from BL @ Week 20 | -16.2 ± 6.81 | -15.7 ± 6.66 |
| Change from BL @ Week 24 | -16.1 ± 6.75 | -15.8 ± 6.46 |
| Change from BL @ Week 28 | -16.1 ± 6.80 | -15.9 ± 6.67 |
All patients with DLQI score 0 and 1 were considered as responders and patients with DLQI score \>=2 were considered as non-responders. Subjects with missing DLQI score were counted as non-responders.
| Participants | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 4 — Non-Responders | 323 | 344 |
| Week 4 — Responders | 43 | 50 |
| Week 8 — Non-Responders | 249 | 269 |
| Week 8 — Responders | 111 | 126 |
| Week 12 — Non-Responders | 179 | 192 |
| Week 12 — Responders | 130 | 143 |
| Week 16 — Non-Responders | 176 | 201 |
| Week 16 — Responders | 178 | 187 |
| Week 20 — Non-Responders | 153 | 170 |
| Week 20 — Responders | 193 | 210 |
| Week 24 — Non-Responders | 148 | 175 |
| Week 24 — Responders | 189 | 203 |
| Week 28 — Non-Responders | 145 | 154 |
| Week 28 — Responders | 189 | 212 |
The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 ("the whole time") to 0 ("at no time point"). The WHO-5 total score is the sum of the 5 questions and ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life.
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Baseline | 10.46 ± 5.208 | 10.62 ± 5.283 |
| Week 4 | 14.45 ± 5.236 | 15.52 ± 4.921 |
| Week 8 | 15.65 ± 4.889 | 15.99 ± 4.697 |
| Week 12 | 15.77 ± 5.083 | 16.37 ± 4.824 |
| Week 16 | 15.91 ± 5.334 | 16.45 ± 4.902 |
| Week 20 | 16.30 ± 5.364 | 16.44 ± 4.978 |
| Week 24 | 16.47 ± 5.173 | 16.55 ± 4.865 |
| Week 28 | 16.20 ± 5.583 | 16.69 ± 4.910 |
The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 ("the whole time") to 0 ("at no time point"). The WHO-5 total score is the sum of the 5 questions and ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life.
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Week 4 | 4.0 ± 5.21 | 4.9 ± 5.51 |
| Week 8 | 5.1 ± 5.61 | 5.4 ± 5.76 |
| Week 12 | 5.2 ± 5.73 | 5.7 ± 5.95 |
| Week 16 | 5.4 ± 5.59 | 5.8 ± 5.85 |
| Week 20 | 5.8 ± 6.08 | 5.8 ± 5.79 |
| Week 24 | 5.9 ± 5.65 | 5.9 ± 6.19 |
| Week 28 | 5.6 ± 6.20 | 5.9 ± 6.12 |
A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject's assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.
| Unit on a scale | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Pain at Baseline | 4.9 ± 2.93 | 4.6 ± 2.87 |
| Pain at week 4 | 1.9 ± 2.29 | 1.7 ± 2.23 |
| Pain at week 8 | 1.1 ± 1.88 | 1.3 ± 2.05 |
| Pain at week 12 | 1.2 ± 2.14 | 1.0 ± 1.84 |
| Pain at week 16 | 1.1 ± 2.04 | 1.1 ± 1.88 |
| Pain at week 20 | 1.0 ± 1.93 | 1.0 ± 1.81 |
| Pain at week 24 | 1.0 ± 1.91 | 1.0 ± 1.85 |
| Pain at week 28 | 1.2 ± 2.10 | 1.0 ± 2.00 |
| Itching at Baseline | 7.4 ± 2.08 | 7.1 ± 2.39 |
| Itching at week 4 | 3.2 ± 2.43 | 3.0 ± 2.60 |
| Itching at week 8 | 2.4 ± 2.36 | 2.3 ± 2.47 |
| Itching at week 12 | 2.2 ± 2.38 | 2.0 ± 2.29 |
| Itching at week 16 | 2.0 ± 2.29 | 2.0 ± 2.43 |
| Itching at week 20 | 1.9 ± 2.23 | 1.9 ± 2.19 |
| Itching at week 24 | 1.9 ± 2.35 | 1.8 ± 2.23 |
| Itching at week 28 | 2.0 ± 2.47 | 1.9 ± 2.38 |
| Scaling at Baseline | 7.5 ± 2.01 | 7.3 ± 2.17 |
| Scaling at week 4 | 2.7 ± 2.18 | 2.4 ± 2.16 |
| Scaling at week 8 | 1.7 ± 1.94 | 1.7 ± 2.03 |
| Scaling at week 12 | 1.7 ± 2.00 | 1.6 ± 1.90 |
| Scaling at week 16 | 1.6 ± 2.10 | 1.5 ± 1.95 |
| Scaling at week 20 | 1.6 ± 2.10 | 1.5 ± 1.98 |
| Scaling at week 24 | 1.7 ± 2.22 | 1.4 ± 1.84 |
| Scaling at week 28 | 1.8 ± 2.28 | 1.5 ± 2.04 |
A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject's assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.
| Percentage change | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention |
|---|---|---|
| Pain at week 4 | -61.4 ± 44.13 | -60.2 ± 59.10 |
| Pain at week 8 | -74.4 ± 44.39 | -68.5 ± 53.86 |
| Pain at week 12 | -72.2 ± 54.73 | -76.6 ± 40.64 |
| Pain at week 16 | -77.3 ± 38.93 | -74.0 ± 46.10 |
| Pain at week 20 | -78.4 ± 41.88 | -75.2 ± 43.55 |
| Pain at week 24 | -78.4 ± 41.88 | -75.7 ± 47.05 |
| Pain at week 28 | -76.3 ± 42.22 | -75.3 ± 52.42 |
| Itching at week 4 | -54.1 ± 33.82 | -55.8 ± 41.19 |
| Itching at week 8 | -63.7 ± 39.78 | -66.7 ± 34.31 |
| Itching at week 12 | -66.6 ± 40.58 | -70.0 ± 33.53 |
| Itching at week 16 | -70.6 ± 34.79 | -70.0 ± 35.79 |
| Itching at week 20 | -71.1 ± 37.64 | -73.0 ± 35.36 |
| Itching at week 24 | -69.6 ± 46.85 | -72.6 ± 35.64 |
| Itching at week 28 | -68.5 ± 48.46 | -72.1 ± 35.97 |
| Scaling at week 4 | -62.2 ± 30.65 | -64.9 ± 34.27 |
| Scaling at week 8 | -74.9 ± 38.02 | -75.1 ± 30.50 |
| Scaling at week 12 | -76.5 ± 29.91 | -76.9 ± 31.93 |
| Scaling at week 16 | -74.3 ± 40.92 | -77.2 ± 32.84 |
| Scaling at week 20 | -76.4 ± 31.93 | -76.2 ± 36.76 |
| Scaling at week 24 | -75.4 ± 35.21 | -78.2 ± 33.38 |
| Scaling at week 28 | -74.3 ± 36.50 | -77.7 ± 35.84 |
Collected over On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | 2/371 (0.5%) | 18/371 (4.9%) | 178/371 (48%) |
| Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | 0/409 (0%) | 20/409 (4.9%) | 204/409 (49.9%) |
| Extension Period: Lifestyle Intervention | 0/189 (0%) | 11/189 (5.8%) | 101/189 (53.4%) |
| Extension Period: Lifestyle Intervention + Secukinumab | 0/164 (0%) | 10/164 (6.1%) | 103/164 (62.8%) |
| Extension Period: Secukinumab | 2/427 (0.5%) | 32/427 (7.5%) | 225/427 (52.7%) |
| Event | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Extension Period: Lifestyle Intervention | Extension Period: Lifestyle Intervention + Secukinumab | Extension Period: Secukinumab |
|---|---|---|---|---|---|
| Varicose veinVascular disorders | 1/371 | 1/409 | 0/189 | 2/164 | 0/427 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/371 | 1/409 | 0/189 | 1/164 | 4/427 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/371 | 1/409 | 0/189 | 1/164 | 3/427 |
| PsoriasisSkin and subcutaneous tissue disorders | 2/371 | 1/409 | 1/189 | 0/164 | 3/427 |
| PericarditisCardiac disorders | 0/371 | 0/409 | 0/189 | 1/164 | 0/427 |
| GoitreEndocrine disorders | 0/371 | 1/409 | 0/189 | 1/164 | 0/427 |
| Pulpitis dentalInfections and infestations | 0/371 | 1/409 | 0/189 | 1/164 | 0/427 |
| TonsillitisInfections and infestations | 0/371 | 1/409 | 0/189 | 1/164 | 0/427 |
| Upper respiratory tract infectionInfections and infestations | 0/371 | 1/409 | 0/189 | 1/164 | 0/427 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/371 | 0/409 | 0/189 | 1/164 | 0/427 |
| Event | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Extension Period: Lifestyle Intervention | Extension Period: Lifestyle Intervention + Secukinumab | Extension Period: Secukinumab |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 83/371 | 96/409 | 41/189 | 49/164 | 108/427 |
| HeadacheNervous system disorders | 40/371 | 36/409 | 18/189 | 20/164 | 40/427 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/371 | 40/409 | 18/189 | 19/164 | 19/427 |
| PsoriasisSkin and subcutaneous tissue disorders | 17/371 | 18/409 | 19/189 | 19/164 | 37/427 |
| Back painMusculoskeletal and connective tissue disorders | 23/371 | 22/409 | 19/189 | 9/164 | 23/427 |
| PruritusSkin and subcutaneous tissue disorders | 16/371 | 17/409 | 3/189 | 14/164 | 22/427 |
| DiarrhoeaGastrointestinal disorders | 19/371 | 22/409 | 14/189 | 10/164 | 23/427 |
| FatigueGeneral disorders | 14/371 | 10/409 | 2/189 | 9/164 | 16/427 |
| Alanine aminotransferase increasedInvestigations | 10/371 | 7/409 | 2/189 | 9/164 | 9/427 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 6/371 | 16/409 | 3/189 | 9/164 | 11/427 |
Following the intent-to-treat principle, patients in the Full Analysis Set (FAS) were analyzed according to the treatment assigned at randomization.
| Age, Continuous(Years) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Total |
|---|---|---|---|
| Mean | 50.4 ± 13.29 | 50.1 ± 12.48 | 50.2 ± 12.86 |
| Sex: Female, Male(Participants) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Total |
|---|---|---|---|
| Female | 105 | 115 | 220 |
| Male | 266 | 294 | 560 |
| Race/Ethnicity, Customized(Participants) | Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) | Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention | Total |
|---|---|---|---|
| Asian | 7 | 1 | 8 |
| Caucasian | 359 | 397 | 756 |
| Black or African American | 2 | 2 | 4 |
| Unknown | 0 | 1 | 1 |
| Other | 3 | 8 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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
Ran from Feb 2018 to primary completion in Nov 2021, 45 months.
Results were first posted in Apr 2026, 4 years 4 months after primary completion. A results delay was requested in Dec 2021.
Of 40 industry-sponsored phase 4 interventional studies under Psoriasis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 45 months is above that.
Counting every sponsor, half of 115 studies reached it within 23 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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