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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04237116
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Plaque Psoriasis, Non-alcoholic Fatty Liver Disease

Arms & Interventions

Arms

Experimental: 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

Placebo Comparator: 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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Dresden, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Dresden, , 01097

Site Contact

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