Safety and efficacy study in patients with moderate to severe nail psoriasis
- Conditions
- Moderate to severe nail psoriasisMedDRA version: 14.1Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-005413-40-GR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 195
Men and women at least age 18 at the time of screening
Subjects who have chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement defined by a Nail Psoriasis Severity Index (NAPSI) score = 16 and number of fingernails involved = 4 AND a Psoriasis Area and Severity Index (PASI) score = 12 AND a Body Surface Area (BSA) score = 10%. Subject is a candidate for systemic therapy, defined as having psoriasis considered inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Subjects who have forms of psoriasis other than chronic plaque type psoriasis (e.g.,pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis). Subjects who have drug-induced psoriasis (e.g. new onset or current exacerbation from ß-blockers, calcium channel inhibitors or lithium). Subjects who have active ongoing inflammatory skin diseases other than psoriasis, and any other disease affecting the fingernails that might confound the evaluation of the benefit of secukinumab treatment. Subjects who have ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Subjects who have been exposed to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 Receptor. Subjects who have received any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer. Subjects who have a history of hypersensitivity to constituents of the study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of secukinumab 150 mg and/or 300 mg to placebo in subjects with moderate to severe psoriasis affecting the nails as assessed by NAPSI at Week 16;Secondary Objective: •To assess the efficacy of secukinumab in subjects with moderate to severe psoriasis affecting the nails as assessed by NAPSI over time up to Week 16 compared to placebo and over time up to Week 80<br>•To assess the efficacy of secukinumab in subjects with moderate to severe psoriasis affecting the nails as assessed by PASI 75 and IGA mod 2011 response at Week 16 compared to placebo and over time up to Week 80.<br>•To investigate the overall safety and tolerability of secukinumab 150 mg and 300 mg ;Primary end point(s): Efficacy: change in Nail Psoriasis Severity Index (NAPSI) after 16 weeks of treatment. Each treatment group will be compared to placebo;Timepoint(s) of evaluation of this end point: Baseline, 16 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Efficacy: change in NAPSI over time up to 16 weeks of treatment compared to placebo and over time up to 80 weeks<br>2. Efficacy: change in Psoriasis Area and Severity Index 75 (PASI75) and change in Investigator Global Assessment (IGA mod 2011) over time up to 16 weeks of treatment compared to placebo and over time up to 80 weeks<br>3. Overall safety and tolerability of secukinumab 150 mg and 300 mg<br>4. Development of immunogenicity against secukinumab<br> ;Timepoint(s) of evaluation of this end point: 1. 16 weeks, 80 weeks<br>2. 16 weeks, 80 weeks<br>3. Baseline, up to 88 weeks<br>4. Baseline, 32 weeks, 80 weeks, 88 weeks