Phase 3
N=130
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02362789 ↗Enrolled (actual)
130
Serious AEs
3.8%
Results posted
Dec 2018
Primary outcome: Primary: Pruritus Intensity Visual Analogue Scale Score at Week 32 — 8.8; 27.1 Units on a scale — p=0.0055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pruritus Intensity Visual Analogue Scale Score at Week 32 |
8.8; 27.1 | 0.0055 sig |
Summary
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
Eligibility Criteria
Key Inclusion Criteria
- Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score > 10 at baseline.
- Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline.
Key Exclusion Criteria
- Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes).
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start.
- Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study.
- Pregnancy, breast feeding or inadequate contraception (if necessary)
Data sourced from ClinicalTrials.gov (NCT02362789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.