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

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)

ClinicalTrials.gov Identifier: NCT04237116

Novartis Reference Number: CAIN457ADE15

Last Update: Dec 09, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The aim of this study is 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).

Condition

Plaque Psoriasis

Non-alcoholic Fatty Liver Disease

Phase

Phase 3

Overall status

Recruiting

Enrollment count

90 participants

Start date

Feb 19, 2020

Completion date

Feb 11, 2022

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Biological

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

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

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