Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

Plaque Psoriasis Clinical Trial

— ObePso-S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055494
• Other study ID #: CAIN457AUS07
• Status: Completed
• Phase: Phase 4
• Start date: April 18, 2017
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).

During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.

K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 26, 2019
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Secukinumab
Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48
• Placebo
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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	East Windsor	New Jersey
United States	Novartis Investigative Site	Hot Springs	Arkansas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Santa Ana	California
United States	Novartis Investigative Site	Webster	Texas
United States	Novartis Investigative Site	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52	Response in skin histology/K16 expression to treatment (answered no)	52 weeks
Secondary	Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52	Psoriasis Area and Severity Index 90	52 weeks
Secondary	Change in Systolic Blood Pressure From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in Diastolic Blood Pressure From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in Body Weight From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in Glucose Level From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in Insulin Level From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12	baseline, Week 12
Secondary	Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12	Vital signs: summary statistics for change from baseline to Week 12; Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.	baseline, Week 12
Secondary	Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12	Vital signs: summary statistics for change from baseline to week 12; For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes.	baseline, week 12