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

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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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Lubeck, 23538
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81675
-
Germany
Novartis Investigative Site
Recruiting
Potsdam, 14467
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70178
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]