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

NCT ID: NCT03055494

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2019-02-26

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.

Detailed 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).

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Secukinumab

Eligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: BIOLOGICAL

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

Placebo

Eligible 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

Secukinumab

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Other Intervention Names

AIN457

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Lead Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Investigative Site

Hot Springs, Arkansas, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Santa Ana, California, United States

Novartis Investigative Site

Atlanta, Georgia, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

East Windsor, New Jersey, United States

Novartis Investigative Site

West Orange, New Jersey, United States

Novartis Investigative Site

Buffalo, New York, United States

Novartis Investigative Site

New York, New York, United States

Novartis Investigative Site

New York, New York, United States

Novartis Investigative Site

Portland, Oregon, United States

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Novartis Investigative Site

Webster, Texas, United States

Novartis Investigative Site

Murray, Utah, United States

Novartis Investigative Site

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CAIN457AUS07

Identifier Type: -

Identifier Source: org_study_id