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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2015-002423-26-NO
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 205

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 104