Secukinumab-Phase IV-New Onset plaque Psoriasis-STEPIN Study
Research type
Research Study
Full 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)
IRAS ID
197733
Contact name
Pikun Gangwani
Contact email
Sponsor organisation
Novartis Global Service Center Hyderabad
Eudract number
2015-002423-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The reason for this study is to determine whether a biological drug Secukinumab is more effective than the current standard of care treatment: narrow-band UVB (nb-UVB) phototherapy for the treatment of new onset moderate to severe plaque psoriasis.
The study drug, secukinumab, is a new type of plaque psoriasis medication called a human monoclonal antibodies which binds to and reduces the activity of a messenger protein Interleukin 17A (IL-17A). Researchers believe that IL-17A causes symptoms associated with plaque psoriasis and it is thought that early intervention with a product that targets IL-17 may help to relieve these symptoms and the condition.
This trial will study the superiority of early intervention with secukinumab compared with current standard phototherapy treatment narrow-band ultraviolet light B (nb-UVB) in prolonging symptom-free periods or relieving symptoms and reoccurrence altogether. This will be measured by the amount of participants who achieve greater than 90% reduction in their psoriasis severity, using the psoriasis and severity index tool, whilst receiving secukinumab compared to nb-UVB phototherapy.
The main study will take place in approximately 75 countries in Argentina, Canada and Europe with the aim of recruiting 160 patients who have had their first appearance of plaque psoriasis within the last 12 months and have not received any prior treatment with drugs that work throughout the body or phototherapy treatment.
There are three periods in the study:
-Screening Period: Patient’s eligibility in the study will be assessed.
-Treatment period: a 52 week treatment period where patients will receive either secukinumab or nb-UVB
-Follow-up period: a 156 week period where patients will be followed up to measure their severity in symptoms of plaque psoriasis and additional tests of their quality of life and disease activity.The recruitment period will be 12 months.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0489
Date of REC Opinion
25 Jan 2017
REC opinion
Further Information Favourable Opinion