Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

Plaque Psoriasis Clinical Trial

Official title:

A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547714
• Other study ID #: CAIN457AJP01
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2015
• Last updated: January 24, 2017
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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)

Exclusion 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 µmol/L [2.0 mg/dL]) and hypertension at screening.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• secukinumab 150 mg
secukinumab 300 mg during Baseline Visit (Day 1) and at Week 1, 2, 3, 4, 8 and 12

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Isehara-city	Kanagawa
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis area and severity index (PASI) 75 response rate	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.	Week 16
Secondary	reduction in PASI score	To evaluate any reduction in PASI score compared to the baseline PASI at Week 4	Week 4
Secondary	PASI 50 and PASI 75 response	To evaluate PASI 50 and PASI 75 response rates at Week 4	Week 4
Secondary	PASI 90 and Investigator's Global Assessment (IGA) 0 or 1 response	To evaluate PASI 90 and Investigator's Global Assessment (IGA) 0 or 1 response rates at Week 16	Week 16
Secondary	Dermatology Life Quality Index (DLQI) score	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	Week 16
Secondary	the safety and tolerability	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	Up to Week 16