NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Plaque Psoriasis
Date of first enrollment	27/10/2015
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AIN457 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : secukinumab 300 mg during Baseline Visit (Day 1) and at Week 1, 2, 3, 4, 8 and 12

Outcome(s)

Primary Outcome

Psoriasis area and severity index (PASI) 75 response rate [ Time Frame: Weeks 16 ] To evaluate the efficacy of secukinumab s.c. at 16 weeks of treatment after immediate withdrawal of cyclosporine A. Efficacy of secukinumab treatment will be evaluated with respect to the proportion of patients achieving >= 75% improvement in psoriasis activity from baseline (PASI 75 response rate) at Week 16.

Secondary Outcome

Reduction in PASI score [ Time Frame: Weeks 4 ] To evaluate any reduction in PASI score compared to the baseline PASI at Week 4 PASI 50 and PASI 75 response [ Time Frame: Weeks 4 ] To evaluate PASI 50 and PASI 75 response rates at Week 4 PASI 90 and Investigator's Global Assessment (IGA) 0 or 1 response rates [ Time Frame: Weeks 16 ] To evaluate PASI 90 and Investigator's Global Assessment (IGA) 0 or 1 response rates at Week 16 Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 16 ] To evaluate Dermatology Life Quality Index (DLQI) score in percent change from baseline and the number of patients achieving DLQI 0 or 1 at Week 16 The safety and tolerability (adverse event including SAE, laboratory test value, number of patients who are over notable criteria about laboratory test, abnormal ECG) [ Time Frame: Up to Week 16 ] To evaluate the safety and tolerability of secukinumab s.c. after immediate cessation of precedent treatment with cyclosporine A. Safety will evaluate with Number of adverse event including SAE, change from baseline of laboratory test value (hematology, chemistry and urinalysis), number of patients who are over notable criteria about laboratory test and occurrence of abnormal ECG observation

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Plaque psoriasis diagnosed for at least 6 months before baseline -Treated with cyclosporine A for at least 12 weeks prior to baseline -Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by: -PASI score of 10 or greater and -IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
Exclude criteria	-Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium). -Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 micromol/L [2.0 mg/dL]) and hypertension at screening. Other protocol defined inclusion/exclusion criteria may apply.