Study of efficacy and safety of secukinumab 2 mL pre-filled syringe (300 mg) in subjects with moderate to severe plaque psoriasis
- Conditions
- Plaque psoriasisMedDRA version: 19.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-005170-38-LV
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
* Men or women of at least 18 years of age at the time of Screening.
* Moderate to severe chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
* Candidate for systemic therapy.
* Additional inclusion criteria may apply , please refer to the protocol.
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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
* Ongoing use of prohibited treatments.
* Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
* Pregnant or nursing (lactating) women
*Additional exclusion criteria may apply , please refer to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: •To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 90 and PASI 100 at Week 12, compared to placebo.<br>•To demonstrate the efficacy of secukinumab 300 mg when administered as two 1 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 100 at Week 12, compared to placebo.<br>;Main Objective: To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PASI 90 and PASI 100;Timepoint(s) of evaluation of this end point: Week 12