Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

Conditions

• Moderate to Severe Palmoplantar Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• secukinumab 150 mg — BIOLOGICAL
  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.
• secukinumab 300 mg — BIOLOGICAL
  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 — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Jun 19, 2013

Status verified

Jan 2018

Primary completion

Nov 2, 2016

Completion

Nov 2, 2016

Study Design

Enrollment

205 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: secukinumab 150mg
  201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
• Experimental: secukinumab 300 mg
  201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
• Placebo Comparator: Placebo
  201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were administered by sub-cutaneous injections.

Primary Outcome Measure

Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment [ Time Frame: Week 16 ]

Locations (8)

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