Assessment of Efficacy and Safety of Secukinumab in Adult Patients in Turkish Population

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02795416
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • "Secukinumab" "Cosentyx TM" — DRUG
    "Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month

Study Details

Secukinumab targets a different interleukin and has potential to be used as alternative to existing treatments. This study will provide clinical data with respect to efficacy through Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and evaluate the impact of the treatment on quality of life and work productivity in subjects with moderate to severe plaque psoriasis in the Turkish population.

Key Dates

Start date
Jun 30, 2016
Status verified
Apr 2017
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: "Secukinumab" "Cosentyx TM"
    "Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit. First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month

Primary Outcome Measure

Percentage of PASI 90 responder patients at Week 16 as compared to baseline [ Time Frame: 16 week ]

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