Phase 4
Completed N=82
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
Source: ClinicalTrials.gov NCT03055494 ↗Enrolled (actual)
82
Serious AEs
2.4%
Results posted
Mar 2020
Primary outcomePrimary: Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 — 43; 1 Participants
◆ Published Evidence
Not yet cited
0citations
Cutaneous adipose tissue carries a strong inflammatory signature in patients with psoriasis.
Summary
This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.
Linked Publications
-
Cutaneous adipose tissue carries a strong inflammatory signature in patients with psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 |
43; 1 | — |
| PRIMARY Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12 |
29; 0 | — |
| SECONDARY Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52 |
33; 20 | — |
| SECONDARY Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52 |
31; 20 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 12 |
-2.6; -1.5 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Week 12 |
-0.5; -0.2 | — |
| SECONDARY Change in Body Weight From Baseline to Week 12 |
0.340; 0.096 | — |
| SECONDARY Change in Glucose Level From Baseline to Week 12 |
0.027; 0.332 | — |
| SECONDARY Change in Insulin Level From Baseline to Week 12 |
15.037; 141.035 | — |
| SECONDARY Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12 |
-5.010; -1.273 | — |
| SECONDARY Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12 |
0.620; 7.646 | — |
| SECONDARY Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12 |
0.018; 0.014 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed
- Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
- Moderate to severe plaque psoriasis as defined at baseline by:
- ≥10% Body Surface Area (BSA) involvement and
- PASI total score of ≥12 and
- IGA mod 2011 score of ≥3 (based on a scale of 0-4)
Exclusion Criteria
- Forms of diagnosed psoriasis other than chronic plaque psoriasis
- Medication-induced or medication exacerbated psoriasis
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
- Ongoing use of prohibited treatments
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03055494) 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.