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 — METABOLYX  

Metabolic Syndrome Clinical Trial

Official title: A Randomized, Multicenter 28 Week Study to Compare the Efficacy and Safety of Combining Cosentyx (Secukinumab) (4-weekly, 300 mg s.c.) With a Lifestyle Intervention to Cosentyx Therapy Alone in Adult Patients With Moderate to Severe Plaque-type Psoriasis and Concomitant Metabolic Syndrome, Followed by a 28 Week Extension Period

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This study included Core study with a duration of 28 weeks followed by an Extension period (exploratory period) with a duration of 28 weeks.

Core study:

After providing informed consent, patients were screened for eligibility for a period of 1 to 4 weeks prior to inclusion in the study. Eligible patients were randomized to one of the two treatment arms, which were the following:

• Arm A: Patients in arm A received a regular induction followed by 4-weekly maintenance treatment with secukinumab 300 mg s.c. until Week 28, where they completed the core study. The last secukinumab injection was to be administered at Week 24.

• Arm B: Patients in arm B received a regular induction followed by 4-weekly maintenance treatment with secukinumab 300 mg s.c. until Week 28. The last secukinumab injection was to be administered at Week 24. In addition to secukinumab treatment, patients in arm B participated in a lifestyle intervention program.

A biomarker sub-study was conducted during the core study in a subgroup of 100 patients (50 from each treatment arm).

The core study ended at Week 28.

Extension period (exploratory period):

After 28 weeks, the study continued with an extension period, during which lifestyle intervention was offered to all patients, irrespective of their prior treatment arm. This meant that patients of arm B, who were willing to, could continue their previously started lifestyle intervention program, and patients of arm A, who were willing to, could start the lifestyle intervention program at the beginning of the extension period. All patients, irrespective of their decision whether to start/continue lifestyle intervention or not, had to participate in the extension period and visit their dermatologic study center for scheduled visits. The extension period ended at Week 56, where all patients completed the study. No study drug was supplied during the extension period. The treating physician could choose psoriasis therapy freely according to their discretion. ;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Psoriasis
• Syndrome

• NCT number: NCT03440736
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2018
• Completion date: June 3, 2022