Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Sponsor
Universita di Verona
Study ID
NCT03828643
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab — DRUG
    Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
  • Secukinumab — DRUG
    Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.

Study Details

This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.

Key Dates

Start date
Mar 20, 2019
Status verified
Apr 2019
Primary completion
Apr 12, 2019
Completion
Apr 12, 2019

Study Design

Enrollment
156 participants (actual)

Arms

  • Arm: Cases
    Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.
  • Arm: Controls
    Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.

Primary Outcome Measure

PASI75 [ Time Frame: week 48 ]

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