Phase 4
Completed N=1,660
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Source: ClinicalTrials.gov NCT02752776 ↗Enrolled (actual)
1,660
Serious AEs
7.2%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 — 74.7; 71.3; 61.7; 70.8 Percentage of participants
◆ Published Evidence
Established
70citations · ~18 / year
Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
Summary
Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.
Linked Publications (2)
-
Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
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Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16 |
74.7; 71.3; 61.7; 70.8 | — |
| SECONDARY Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52 |
75.3; 73.3; 62.0; 71.9 | — |
| SECONDARY Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 |
18.3; 19.1; 21.2; 19.2; 5.7; 6.3 | — |
| SECONDARY Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 |
97.7; 97.5; 95.0; 97.1; 94.4; 92.8 | — |
| SECONDARY Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 |
0.217; 0.201; 0.235; 0.214; 0.221; 0.193 | — |
| SECONDARY Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 |
19.7; 21.4; 18.7; 20.2; 21.7; 22.6 | — |
| SECONDARY Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 |
-0.7; -0.5; -0.3; -0.5; -0.7; -0.5 | — |
| SECONDARY Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 |
-3.0; -3.3; -3.3; -3.2; -3.1; -3.2 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 |
81.5; 80.9; 75.0; 80.0; 85.1; 82.0 | — |
| SECONDARY Patient Benefit Index (PBI) at Week 16 and Week 52 |
3.5; 3.4; 3.2; 3.4; 3.5; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women aged at least 18 years at time of Screening.
- Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
- Other protocol defined inclusion criteria may apply. Please refer to the protocol.
Exclusion Criteria
- Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
- Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they use effective contraception
Data sourced from ClinicalTrials.gov (NCT02752776) and the linked publication. 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.