Phase
Condition
Rash
Primary Biliary Cholangitis
Liver Disease
Treatment
Investigational Arm - secukinumab
Control Arm - placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Novartis Investigative Site
Dresden, 01097
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Heidelberg, 69120
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04103
GermanySite Not Available
Novartis Investigative Site
Lubeck, 23538
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39120
GermanySite Not Available
Novartis Investigative Site
Muenchen, 80377
GermanySite Not Available
Novartis Investigative Site
Potsdam, 14467
GermanySite Not Available
Novartis Investigative Site
Stuttgart, 70178
GermanySite Not Available
Novartis Investigative Site
Tuebingen, 72076
GermanySite Not Available
Novartis Investigative Site
Tübingen, 72076
GermanySite Not Available
Novartis Investigative Site
Wuerzburg, 97080
GermanySite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41013
SpainSite Not Available
Novartis Investigative Site
Badalona, Catalunya 08916
SpainSite Not Available
Novartis Investigative Site
Valencia, Comunidad Valenciana 46014
SpainSite Not Available
Novartis Investigative Site
Barcelona, 08041
SpainSite Not Available
Novartis Investigative Site
Madrid, 28041
SpainSite Not Available
Novartis Investigative Site
Pontevedra, 36003
SpainSite Not Available
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