Phase 3
Completed N=120
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
Source: ClinicalTrials.gov NCT02595970 ↗Enrolled (actual)
120
Serious AEs
10.8%
Results posted
Apr 2019
Primary outcomePrimary: proSPI (s) at Week 16 Compared to Baseline — 24.89; 2.34 scores on a scale — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY proSPI (s) at Week 16 Compared to Baseline |
24.89; 2.34 | <0.0001 sig |
| PRIMARY Changes of saSPI (s) at Week 16 Compared to Baseline |
23.54; 1.99 | <0.0001 sig |
| SECONDARY PASI (Psoriasis Area Severity Index) Score |
23.09; 2.23; 3.16 | — |
| SECONDARY Correlation Between PASI and proSPI (s) |
0.691; 0.814; 0.927 | — |
| SECONDARY proSPI (s, p and i) Over Time |
24.89; 1.83; 2.93; 7.80; 1.34; 1.59 | — |
| SECONDARY saSPI (s, p and i) Over Time |
23.54; 1.80; 2.15; 8.18; 1.54; 1.47 | — |
| SECONDARY DLQI (Dermatology Life Quality Index) Over Time |
13.6; 2.1; 1.9 | — |
| SECONDARY Self-administered PASI (SA-PASI) |
25.8; 2.6; 3.3 | — |
| SECONDARY Psoriasis Symptom Diary (PSD) Score |
5.2; 0.9; 0.9; 6.7; 1.3; 1.4 | — |
| SECONDARY Correlation Between proSPI (for Each Component: s, p and i) and DLQI |
0.224; 0.418; 0.514; 0.494; 0.671; 0.757 | — |
| SECONDARY Correlation Between proSPI (for Components p and i) and PASI |
0.173; 0.678; 0.749; 0.014; 0.105; 0.172 | — |
Eligibility Criteria
Inclusion Criteria
- patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
- patient candidates for systemic therapy.
- informed consent.
Exclusion Criteria
- previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
- recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
Data sourced from ClinicalTrials.gov (NCT02595970). 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. Informational only — not medical advice.