Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Conditions

• Palmoplantar Pustular Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab 300mg — BIOLOGICAL
  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 150mg — BIOLOGICAL
  secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
• Placebo — BIOLOGICAL
  secukinumab placebo s.c. (two PFS injections of placebo) self-administered

Study Details

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

Key Dates

Start date

Dec 26, 2013

Status verified

Jan 2019

Primary completion

Nov 24, 2014

Completion

May 31, 2017

Study Design

Enrollment

237 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab 300mg
  Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
• Experimental: Secukinumab 150mg
  Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
• Placebo Comparator: Placebo
  Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.

Primary Outcome Measure

Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) [ Time Frame: Baseline to Week 16 ]