Ignite Creation Date:
2024-05-06 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03440736
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2018-01-31
Brief Title:
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
Organization:
Novartis
Study Overview
Official Title:
A Randomized Multicenter 28 Week Study to Compare the Efficacy and Safety of Combining Cosentyx Secukinumab 4-weekly 300 mg sc 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
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METABOLYX
Brief 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
Detailed 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 sc 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 sc 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 startcontinue 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
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 sc 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 sc 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 startcontinue 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001671-79 | EUDRACT_NUMBER | None | None |