Study of the efficacy of early intervention with secukinumab 300 mg s.c. compared to narrow-band UVB in patients with new-onset moderate to severe plaque psoriasis
- Conditions
- Plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002423-26-BG
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
* Aged 18 to 50 years inclusive
* moderate to severe plaque psoriasis with either new onset or lasting for at least 5 years.
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 196
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
* Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced)
* Ongoing use of prohibited treatments
* Pregnant or nursing (lactating) women
* Women of child-bearing potential not willing to use contraception
*Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy
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 Main Objective: To demonstrate that early treatment with secukinumab 300 mg s.c. is superior to treatment with nb-UVB in patients with new-onset moderate to severe plaque psoriasis with respect to patients achieving PASI 90 response at Week 52;Secondary Objective: to evaluate the superiority of early treatment with secukinumab (Arm<br>A1) versus nb-UVB (Arm B1) based on the proportion of all randomized<br>patients who achieve at least PASI 90 at Week 104.<br>Additional secondary objective<br>To evaluate the effects of early treatment with secukinumab (Arm A1)<br>compared with nb UVB (Arm B1) based on the proportion of all<br>randomized patients who achieve at least investigator's global<br>assessment (IGA mod 2011) of 0 or 1 at Week 52 and at Week 104;Primary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PASI 90 response;Timepoint(s) of evaluation of this end point: Week 104