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

Conditions

• Moderate to Severe Nail Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab — BIOLOGICAL
  Study treatment was provided in pre-filled 1 mL syringes.
• Placebo — BIOLOGICAL
  Placebo was provided in pre-filled 1 mL syringes.

Study Details

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

Key Dates

Start date

Jun 20, 2013

Status verified

Feb 2018

Primary completion

Jan 3, 2017

Completion

Jan 3, 2017

Study Design

Enrollment

198 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab (AIN457) 150 mg
  Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
• Experimental: Secukinumab (AIN457) 300 mg
  Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
• Placebo Comparator: Placebo
  Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.

Primary Outcome Measure

Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment [ Time Frame: Baseline, 16 weeks ]

Locations (9)

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