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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002423-26-ES

Enrollment

205

Registered

2016-10-19

Start date

2016-12-16

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.;Primary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

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.;Primary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 52

—

Secondary

Measure	Time frame
Secondary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 104	—

Countries

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

Contacts

Public ContactDepartamento Médico

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com0034900353036

Outcome results

None listed

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