A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT04237116

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2021-07-23

Brief Summary

The aim of this study was to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic triglyceride content) and anti-fibrotic (reduction of hepatic fibrosis) effects of secukinumab in patients with psoriasis and coexisting non-alcoholic fatty liver disease (NAFLD).

Detailed Description

Primary outcome measure is Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline. Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in score compared to Baseline. It is a composite score where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. Score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Primary analysis was planned to be performed comparing treatments with respect to the primary efficacy variable in a logistic regression model. It was planned to present the Odds Ratio and its 95%-confidence interval and p-value. Planned null hypothesis to be rejected was that the Odds Ratio of a PASI90 response for patients with secukinumab vs. patients with placebo is ≥1 after 12 weeks. Due to premature termination and limited number of treated patients with available data (7 in the secukinumab group and 3 in the placebo group), the extent of the originally planned statistical analyses of efficacy data was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and SD) for the score.

Conditions

Plaque Psoriasis; Non-alcoholic Fatty Liver Disease

Study Design

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

Study Groups

Investigational Arm - secukinumab

secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind

Group Type: EXPERIMENTAL

Investigational Arm - secukinumab

Intervention Type: BIOLOGICAL

secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind

Control Arm - placebo

placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20

Group Type: PLACEBO_COMPARATOR

Control Arm - placebo

Intervention Type: BIOLOGICAL

placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20

Interventions

Investigational Arm - secukinumab

secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind

Intervention Type: BIOLOGICAL

Control Arm - placebo

placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20

Intervention Type: BIOLOGICAL

Other Intervention Names

AIN457; AIN457

Eligibility Criteria

Inclusion Criteria

• Male/female patients, 18 years or older
• Moderate to severe plaque-type psoriasis, candidate for systemic therapy
• Diagnosis of NAFLD by either ultrasound at Screening or liver histology within 6 months before Baseline
• BMI > 25 kg/ m 2
• ALT 1.2 to 3.0 × ULN
• MRI confirmed Liver fat ≥ 8% at Screening

Exclusion Criteria

• Forms of psoriasis other than chronic plaque-type Psoriasis
• Drug induced psoriasis
• Pregnant or nursing (lactating) women
• Women of child bearing potential unless they are using effective methods of contraception
• Ongoing use of prohibited treatments
• Previous treatment with biological drug targeting IL-17 or the IL-17 receptor
• Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to Screening
• Unstable weight over the last 6 months prior to Screening.
• Type I diabetes, or uncontrolled diabetes (Type I or Type II) defined as HbAlc ≥ 10% at screening.
• Evidence of hepatic decompensation or severe liver impairment or cirrhosis
• History of liver transplantation or planned liver transplant or biliary diversion.
• Presence or history of other liver disease
• Current, or history of, significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
• Prior or planned bariatric surgery
• Inability or unwillingness to undergo MRI of the abdomen
• Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to Screening

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

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Potsdam, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Novartis Investigative Site

Tübingen, , Germany

Novartis Investigative Site

Würzburg, , Germany

Novartis Investigative Site

Valencia, Valencia, Spain

Countries

Germany; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1386

Plain Language Trial Summary

Other Identifiers

2019-003168-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457ADE15

Identifier Type: -

Identifier Source: org_study_id