Study to assess the differences in terms of efficacy and safety of secukinumab between patients Cw6 negative and Cw6 positive with moderate to severe plaque psoriasis

A 24-week, multicenter, proSpective, open-label stUdy to evaluate the efficacy in terms of non-inferiority with respect to PASI 90 response rate and the safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive patients with moderate to severe chronic plaque-type psoriasis (SUPREME) - SUPREME

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002865-31-IT

Enrollment

406

Registered

2014-09-15

Start date

2014-12-17

Completion date

Unknown

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate to severe chronic plaque-type psoriasis MedDRA version: 17.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. 2. Men or women at least 18 years of age at time of screening. 3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months. 4. Psoriasis of the scalp, hands or diagnosis of concomitant psoriatic arthritis as per CASPAR criteria. 5. Moderate to severe psoriasis as defined at enrollment by: ? PASI score = 10 or ? PASI score > 5 but =65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis). 2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1. 3. Anti-TNFa therapy within timelines depending on drug half-life. 4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that is not anti-TNFa therapy. 6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening. 7. Ongoing use of corticosteroid topical treatments or UV therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks.;Secondary Objective: To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point. To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point. - To compare time to reach PASI 90 between cohorts. - To compare time to reach PASI 75 between cohorts. - To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point. - To evaluate anxiety and depression in all patients at each time point. - To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients. - To evaluate changes from baseline in weight, BMI and waist in all patients at each time point. - To compare safety and tolerability between cohorts for 24 weeks. - To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study.;Primary end point(s): To demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks.;Timepoint(s) of evaluation of this end point: after 16 weeks	—

Measure

Time frame

Main Objective: To demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks.;Secondary Objective: To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point. To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point. - To compare time to reach PASI 90 between cohorts. - To compare time to reach PASI 75 between cohorts. - To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point. - To evaluate anxiety and depression in all patients at each time point. - To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients. - To evaluate changes from baseline in weight, BMI and waist in all patients at each time point. - To compare safety and tolerability between cohorts for 24 weeks. - To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study.;Primary end point(s): To demonstrate the non-inferiority of the efficacy profile in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks.;Timepoint(s) of evaluation of this end point: after 16 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point. - To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point. - To compare time to reach PASI 90 between cohorts. - To compare time to reach PASI 75 between cohorts. - To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point. - To evaluate anxiety and depression in all patients at each time point. - To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients. - To evaluate changes from baseline in weight, BMI and waist in all patients at each time point. - To compare safety and tolerability between cohorts for 24 weeks. - To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study.;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Secondary end point(s): - To compare the proportion of responders to PASI 50/75/90/100 between cohorts at each time point. - To compare the mean changes vs baseline in IGA mod 2011 between cohorts at each time point. - To compare time to reach PASI 90 between cohorts. - To compare time to reach PASI 75 between cohorts. - To evaluate the Quality of Life by means of the Dermatology Life Quality Index (DLQI) in all patients at each time point. - To evaluate anxiety and depression in all patients at each time point. - To evaluate the correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI in all patients. - To evaluate changes from baseline in weight, BMI and waist in all patients at each time point. - To compare safety and tolerability between cohorts for 24 weeks. - To evaluate the amount of resources used during the study in comparison with the 6 months prior to the beginning of the study.;Timepoint(s) of evaluation of this end point: 24 weeks

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Countries

Italy

Contacts

Public ContactDrug Regulatory Affairs

NOVARTIS FARMA S.p.A.

info.studiclinici@novartis.com+390296541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026