A study to evaluate clear skin effect in patients with plaque psoriasis.

An open-label, prospective, non-randomized, multicenter study to evaluate clear skin effect on health related quality of life outcomes at 16 and 52 weeks in patients with moderate to severe plaque psoriasis treated with secukinumab 300 mg s.c. with or without previous exposure to systemic therapy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003701-42-ES

Enrollment

1615

Registered

2015-12-28

Start date

2016-02-15

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Plaque psoriasis MedDRA version: 18.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Interventions

Trade Name: Cosentyx Product Name: Cosentyx (secukinumab) Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or women aged at least 18 years at time of Screening. - Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy. - Other protocol defined inclusion criteria may apply. Please refer to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 145

Exclusion criteria

Exclusion criteria: - Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening. - Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab). - Pregnant or nursing (lactating) women - Women of child-bearing potential unless they use effective contraception - Other protocol-defined exclusion criteria may apply. Please refer to the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the proportion of patients achieving a DLQI 0/1 response at Week 16 in 3 pre defined subpopulations and in the overall study population.;Secondary Objective: To assess: - The proportion of patients achieving a DLQI 0/1 response at Week 52 in 3 pre defined subpopulations and in the overall study population. - The effects of treatment with secukinumab 300 mg with respect to changes in EQ-5D©, HAQ©-DI, NRS, TSQM and PBI response over time up to Week 16 and Week 52 compared to baseline in 3 pre-defined subpopulations and in the overall study population. - The proportion of patients achieving PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0/1 responses at Week 16 and Week 52 in 3 pre-defined subpopulations and in the overall study population. - The proportion of patients with DLQI scores 2-5, 6-10, 11-20, 21-30 at Week 16 and Week 52 compared to Baselinein 3pre-defined subpopulations and in the overall study population. - The overall safety and tolerability of treatment with secukinumab 300 mg in 3 pre-defined subpopulations and in the overall study population.;Primary end point(s): DLQI 0/1 response;Timepoint(s) of evaluation of this end point: week 16	—

Measure

Time frame

Main Objective: To assess the proportion of patients achieving a DLQI 0/1 response at Week 16 in 3 pre defined subpopulations and in the overall study population.;Secondary Objective: To assess: - The proportion of patients achieving a DLQI 0/1 response at Week 52 in 3 pre defined subpopulations and in the overall study population. - The effects of treatment with secukinumab 300 mg with respect to changes in EQ-5D©, HAQ©-DI, NRS, TSQM and PBI response over time up to Week 16 and Week 52 compared to baseline in 3 pre-defined subpopulations and in the overall study population. - The proportion of patients achieving PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0/1 responses at Week 16 and Week 52 in 3 pre-defined subpopulations and in the overall study population. - The proportion of patients with DLQI scores 2-5, 6-10, 11-20, 21-30 at Week 16 and Week 52 compared to Baselinein 3pre-defined subpopulations and in the overall study population. - The overall safety and tolerability of treatment with secukinumab 300 mg in 3 pre-defined subpopulations and in the overall study population.;Primary end point(s): DLQI 0/1 response;Timepoint(s) of evaluation of this end point: week 16

—

Secondary

Measure	Time frame
Secondary end point(s): DLQI 0/1, EQ-5D, HAD-DI, NRS, TSQM, PBI, PASI 50/75/90/100, IGA mod 2011 0/1 response;Timepoint(s) of evaluation of this end point: week 16 - week 52	—

Countries

Belgium, European Union, Germany, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russian Federation, Slovakia, Spain, United Kingdom

Contacts

Public ContactDepartamento Médico (ICRO)

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com+34930353036

Outcome results

None listed

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