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

Novartis

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Secukinumab (AIN457)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02547714

CAIN457AJP01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

Secukinumab (AIN457) 300 mg

Experimental group

Description:

Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.

Treatment:

Drug: Secukinumab (AIN457)