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)

Phase 4

Withdrawn

• Conditions: plaque psoriasis; psoriasis vulgaris; 10014982

• Registration Number: NL-OMON43019
• Lead Sponsor: TFS Trial Form Support BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

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.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate that early treatment with secukinumab 300 mg s.c. (Arm A1) is<br /><br>superior to standard of care treatment with nb-UVB (Arm B1) in patients with<br /><br>new-onset moderate to severe psoriasis with respect to patients achieving * 90%<br /><br>improvement (reduction) in psoriasis area and severity index (PASI 90) response<br /><br>at Week 52.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the superiority of early treatment with secukinumab (Arm A1) versus<br /><br>nb-UVB (Arm B1) based on the proportion of all randomized patients who achieve<br /><br>at least PASI 90 at Week 104.</p><br>