Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
ObePso-S
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore Changes in Subcutaneous Adipose Tissue and Modulation of Skin Inflammation After 12 Weeks of Treatment With Secukinumab, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis
1 other identifier
interventional
102
1 country
15
Brief Summary
This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedStudy Start
First participant enrolled
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2019
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2023
March 1, 2023
1 year
February 14, 2017
February 25, 2020
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12
Response in skin histology/K16 expression to treatment (answered no)
12 weeks
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12
Psoriasis Area and Severity Index 90
12 weeks
Secondary Outcomes (10)
Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52
52 weeks
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52
52 weeks
Change in Systolic Blood Pressure From Baseline to Week 12
baseline, Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
baseline, Week 12
Change in Body Weight From Baseline to Week 12
baseline, Week 12
- +5 more secondary outcomes
Study Arms (2)
Secukinumab
EXPERIMENTALEligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48
Placebo
PLACEBO COMPARATOREligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
Interventions
Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48
Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment is performed
- Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
- Moderate to severe plaque psoriasis as defined at baseline by:
- ≥10% Body Surface Area (BSA) involvement and
- PASI total score of ≥12 and
- IGA mod 2011 score of ≥3 (based on a scale of 0-4)
You may not qualify if:
- Forms of diagnosed psoriasis other than chronic plaque psoriasis
- Medication-induced or medication exacerbated psoriasis
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
- Ongoing use of prohibited treatments
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative Site
Hot Springs, Arkansas, 71913, United States
Novartis Investigative Site
Los Angeles, California, 90033, United States
Novartis Investigative Site
Santa Ana, California, 92701, United States
Novartis Investigative Site
Atlanta, Georgia, 30342, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
East Windsor, New Jersey, 08520, United States
Novartis Investigative Site
West Orange, New Jersey, 07052, United States
Novartis Investigative Site
Buffalo, New York, 14203, United States
Novartis Investigative Site
New York, New York, 10025 1737, United States
Novartis Investigative Site
New York, New York, 10065, United States
Novartis Investigative Site
Portland, Oregon, 97223, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213-3403, United States
Novartis Investigative Site
Webster, Texas, 77004, United States
Novartis Investigative Site
Murray, Utah, 84107, United States
Novartis Investigative Site
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Change in Body Mass Index (BMI) was not measured
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Study Lead Novartis Pharmaceuticals
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 16, 2017
Study Start
April 18, 2017
Primary Completion
April 25, 2018
Study Completion
February 26, 2019
Last Updated
March 10, 2023
Results First Posted
March 10, 2020
Record last verified: 2023-03