Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis

Conditions

• Moderate to Severe Chronic Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• secukinumab 150 mg — DRUG
  sub-cutaneous secukinumab prefilled syringe 150 mg

Study Details

The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.

Key Dates

Start date

Jun 25, 2018

Status verified

Oct 2021

Primary completion

Sep 13, 2019

Completion

Jul 15, 2020

Study Design

Enrollment

331 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Secukinumab 300 mg every 2 weeks (Q2W)
  2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
• Active Comparator: Secukinumab 300 mg every 4 weeks (Q4W)
  2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
• Active Comparator: Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up)
  2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).

Primary Outcome Measure

Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set) [ Time Frame: 16 weeks ]

Locations (38)

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