Plaque Psoriasis Efficacy and Safety With Secukinumab

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02409667
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.

Study Details

To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.

Key Dates

Start date
May 7, 2015
Status verified
Feb 2019
Primary completion
Mar 14, 2017
Completion
May 8, 2017

Study Design

Enrollment
16,487 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Secukinumab 300mg in PASI 90 responders (every 4 weeks)
    Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
  • Experimental: Secukinumab 300mg in PASI 90 responders (longer intervals)
    Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.
  • Experimental: Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)
    Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
  • Active Comparator: Secukinumab 300mg in PASI 75-90 responders (shorter intervals)
    Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.

Primary Outcome Measure

Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 [ Time Frame: Week 52 ]

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