Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03440736
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24)
  • Life-style intervention — BEHAVIORAL
    A structured program to guide weight loss and increased physical activity

Study Details

This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.

Key Dates

Start date
Feb 28, 2018
Status verified
Apr 2026
Primary completion
Nov 30, 2021
Completion
Jun 3, 2022

Study Design

Enrollment
781 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Secukinumab 300 mg subcutaneous (s.c.)
    Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).
  • Experimental: Secukinumab 300 mg subcutaneous (s.c.) and lifestyle intervention
    Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.

Primary Outcome Measure

Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28 [ Time Frame: Baseline, Week 28 ]

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