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

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2015-003701-42-DE
• Date of registration: 29/12/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A study to evaluate clear skin effect in patients with plaque psoriasis.
• Scientific title: 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.
• Date of first enrolment: 18/02/2016
• Target sample size: 1615
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003701-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

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

Intervention(s)

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: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

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.

Primary end point(s): DLQI 0/1 response

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.

Timepoint(s) of evaluation of this end point: week 16

Secondary Outcome(s)

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

Secondary ID(s)

CAIN457A3401

2015-003701-42-ES

Source(s) of Monetary Support

Novartis Pharma Services AG