Clinical trial NCT02547714: Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: cyclosporine A
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
timeFrame: Week 16
Secondary outcomes:
measure: Mean Percent Change From Baseline in PASI Score
timeFrame: Week 4
measure: Percentage of Participants Achieving PASI 50 or PASI 75
timeFrame: Week 4
measure: Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
timeFrame: Week 16
measure: Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 16
measure: Percentage of Participants Achieving DLQI 0 or 1
timeFrame: Week 16
Other outcomes:
Locations:
city: Nagoya city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Isehara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
References: