Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether early intervention with subcutaneous (s.c.)
      secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to
      prolonged symptom-free periods by preventing reactivation of old lesions or ultimately
      totally hindering the occurrence of new lesions, i.e., changing the natural course of the
      disease (Main Study).
    

Detailed description: 
      The design consists of the Main Study and a Mechanistic Sub study:

        1. The Main Study will be multicenter, randomized, 2-treatment-arm (secukinumab and
           nb-UVB), parallel-group and open-label. It will include 3 clinical periods (Screening
           period, Treatment period, and Follow-up period) involving all patients in Arms A1 (A1a
           and A1b) and B1 (B1a and B1b).

        2. The Mechanistic Sub-study will be open-label and comprise 5 treatment arms (A1b, A2,
           B1b, C1, and C2). It will include 2 periods (Screening period and Treatment period) for
           patients in Arms C1, C2 and A2. Patients from Arms A1b and B1b will undergo the 3
           clinical periods of the Main Study.

      The overall study population (Main Study and Mechanistic Sub-study) will consist of a total
      of 196 male and female patients aged between 18 and 50 years inclusive.

        1. Main Study The Main Study will be conducted in patients with new-onset moderate to
           severe plaque psoriasis not previously treated with any systemic treatment or
           phototherapy.

           A total of 160 patients will be randomized to Arm A1 or Arm B1 in approximately 75 sites
           worldwide. Since a maximum screening failure rate of 20% is expected, approximately 245
           patients will be screened.

        2. Mechanistic Sub-study Any patient who consents can participate in the Mechanistic
           Sub-study. Patients with new-onset plaque psoriasis will be randomized to Arm A1b, Arm
           A2, or Arm B1b, those with chronic plaque psoriasis will be randomized to Arm C1 and Arm
           C2 (12 patients each).

      For Arm A1b or Arm B1b, the first 12 patients will be included on a first come first serve
      basis.
    

Intervention name(s): Secukinumab; nb-UVB; Calcipotriol; Betamethasone
Intervention type(s): Biological; Radiation; Drug; Drug
Intervention description(s): Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL.; Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application will be performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face is recommended; Its a topical treatment for Psoriasis. the concentration it is used is 50mcg/g; this is topical cream which is used in 0.5mg/g concentration
Other intervention name(s): AIN457
Intervention MeSH terms: Betamethasone; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; interleukin (IL) 17A; IL-17A; secukinumab; AIN457; Narrow-band ultraviolet light B; nb-UVB; Psoriasis area and severity index; PASI