NCT03828643

Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Secukinumab	Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
DRUG	Secukinumab	Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-04-12
• Completion: 2019-04-12
• First posted: 2019-02-04
• Last updated: 2019-04-16

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study