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

Last updated: February 27, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Rash

Primary Biliary Cholangitis

Liver Disease

Treatment

Investigational Arm - secukinumab

Control Arm - placebo

Clinical Study ID

NCT04237116
CAIN457ADE15
2019-003168-37
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 6months before Baseline
  • BMI > 25 kg/ m 2
  • ALT 1.2 to 3.0 × ULN
  • MRI confirmed Liver fat ≥ 8% at Screening

Exclusion

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 ofcontraception
  • 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 3consecutive 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

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Investigational Arm - secukinumab
Phase: 3
Study Start date:
February 19, 2020
Estimated Completion Date:
July 23, 2021

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Dresden, 01097
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lubeck, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 80377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam, 14467
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70178
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41013
    Spain

    Site Not Available

  • Novartis Investigative Site

    Badalona, Catalunya 08916
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46014
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, 08041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Pontevedra, 36003
    Spain

    Site Not Available

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