Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
Condition: Moderate to Severe Palmoplantar Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab 150 mg; secukinumab 300 mg; Placebo
Intervention description: Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.; Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.; Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
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: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Skin condition, itching, psoriasis vulgaris, relapsing remitting psoriasis, immune-med systemic disease, skin lesions, scaly patches, papules, plaques

Summary:

      Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on
      palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of
      secukinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months
             prior to randomization and significant involvement of the palms and soles at baseline,
             defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a
             5-point scale, as well as at least one skin plaque at baseline which is not in the
             palmoplantar area

          -  Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical
             treatment (including super potent topical corticosteroids) and/or phototherapy and/or
             previous systemic therapy

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis,
             palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate
             psoriasis)

          -  Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers,
             calcium channel inhibitors or lithium)

          -  Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS),
             UV therapy). Washout periods do apply.

          -  Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting
             IL-17 or the IL-17 receptor

          -  Use of any investigational drugs within 4 weeks prior to study treatment initiation or
             within a period of 5 half-lives of the investigational treatment, whichever is longer

          -  Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of secukinumab therapy

          -  History of hypersensitivity to constituents of the study treatment