A Randomized, Double-blind, Multicenter, 24-week Study of Subcutaneous Secukinumab to Assess Anti-interleukin-17A Treatment in Plaque Psoriasis Patients With Coexisting Non-alcoholic Fatty Liver Disease (pINPOINt)

CAIN457ADE15

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).

2020-02-19

2021-06-29

2021-07-23

Terminated

Early phase I

10

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2024-02-29