Phase 2
Completed N=36
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Psoriasis, Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01537432 ↗
Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 — 56.5; 0.0 percentage of participants — p=<0.001
Summary
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 |
56.5; 0.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52 |
62.5; 33.3 | — |
Eligibility Criteria
Inclusion criteria
- Chronic plaque-type psoriasis diagnosed for at least 6 months
- Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
- Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
Exclusion criteria
- Forms of psoriasis other than chronic plaque-type
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
- History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT01537432). 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.