Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
Condition: Palmoplantar Pustular Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab 300mg; Secukinumab 150mg; Placebo
Intervention description: Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered; secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered; secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: palmoplantar, pustular, psoriasis

Summary:

      A one year study assessing the efficacy and safety of secukinumab compared with placebo in
      adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an
      optional extension treatment period of up to a total of 148 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Palmoplantar pustular psoriasis for at least 6 months before Randomization

          -  Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:

               -  ppPASI score of ≥ 12 and

               -  DLQI ≥ 10

          -  Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis
             inadequately controlled by:

               -  Topical treatment, and/or

               -  Phototherapy, and/or

               -  Previous systemic therapy

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar
             psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)

          -  Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers,
             calcium channel inhibitors, or lithium) or history of proven contact dermatitis

          -  Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of
             tanning devices) during the course of the study

          -  Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic
             corticosteroids, UV therapy). Washout periods detailed in the protocol have to be
             adhered to

          -  Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor
             (e.g., secukinumab, ixekizumab, or brodalumab)

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using effective methods of contraception during
             dosing of study treatment and for 16 weeks after stopping treatment

          -  Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of secukinumab therapy

          -  Use of any other investigational drugs within 4 weeks of study drug initiation or
             within a period of 5 half-lives of the investigational treatment, whichever is longer

        Other protocol-defined inclusion/exclusion criteria may apply.