A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Plaque Psoriasis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Psoriasis
Intervention: Investigational Arm - secukinumab; Control Arm - placebo
Intervention description: 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; 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The primary objective of this study was to demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic plaque-type psoriasis and non-alcoholic fatty liver disease (NAFLD) with respect to psoriasis area and severity index (PASI) 90 response at Week 12.
Masking: Double (Participant, Investigator)
Masking description: double-blind
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; NAFLD; NASH; PASI; secukinumab; non-alcoholic fatty liver disease

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 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