Study of the efficacy of early intervention with secukinumab 300 mg s.c. compared to narrow-band UVB in patients with new-onset moderate to severe plaque psoriasis

• Register: EUCTR
• Last refreshed on: 11 September 2023
• Main ID: EUCTR2015-002423-26-ES
• Date of registration: 19/10/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: Study of the efficacy of early intervention with secukinumab 300 mg s.c. compared to narrow-band UVB in patients with new-onset moderate to severe plaque psoriasis
• Scientific title: A randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study) - STEPin
• Date of first enrolment: 16/12/2016
• Target sample size: 205
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002423-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: nb-UVB Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Departamento Médico
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
* Aged 18 to 40 years inclusive
* moderate to severe plaque psoriasis with either new onset or lasting for at least 5 years.

Additional 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 205
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
* Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced)
* Ongoing use of prohibited treatments
* Pregnant or nursing (lactating) women
* Women of child-bearing potential not willing to use contraception
*Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy

Additional 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

Plaque psoriasis
MedDRA version: 19.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

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

Intervention(s)

Trade Name: COSENTYX
Product Name: 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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 52

Primary end point(s): PASI 90 response

Main Objective: To demonstrate that early treatment with secukinumab 300 mg s.c. is superior to treatment with nb-UVB in patients with new-onset moderate to severe plaque psoriasis with respect to patients achieving PASI 90 response at Week 52

Secondary Objective: To evaluate the superiority of early treatment with secukinumab vs nb-UVB based on the proportion of patients who achieve at least PASI 90 at Week 104.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 104

Secondary end point(s): PASI 90 response

Secondary ID(s)

CAIN457A2322

Source(s) of Monetary Support

Novartis Farmacéutica, S.A.

Ethics review

Status: Approved
Approval date: 14/12/2016
Contact: