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

Primary Purpose

Plaque Psoriasis, Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Investigational Arm - secukinumab
Control Arm - placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque psoriasis, NAFLD, NASH, PASI, secukinumab, non-alcoholic fatty liver disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational Arm - secukinumab

Control Arm - placebo

Arm Description

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 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

Outcomes

Primary Outcome Measures

Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline
Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in PASI score compared to Baseline

Secondary Outcome Measures

Serum Alanine Aminotransferase (ALT) level
ALT is an enzyme that the liver releases when it becomes inflamed or damaged. ALT level measures liver function Parameter.
Percentage of patients achieving DLQI 0/1 at week 12
Dermatology Life Quality Index (DLQI) is calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life.

Full Information

First Posted
January 20, 2020
Last Updated
January 12, 2022
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04237116
Brief Title
A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
Acronym
pINPOINt
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
July 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis, Non-alcoholic Fatty Liver Disease
Keywords
plaque psoriasis, NAFLD, NASH, PASI, secukinumab, non-alcoholic fatty liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The primary objective of this study is 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.
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Arm - secukinumab
Arm Type
Experimental
Arm Description
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
Arm Title
Control Arm - placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Investigational Arm - secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Control Arm - placebo
Other Intervention Name(s)
AIN457
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline
Description
Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in PASI score compared to Baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum Alanine Aminotransferase (ALT) level
Description
ALT is an enzyme that the liver releases when it becomes inflamed or damaged. ALT level measures liver function Parameter.
Time Frame
12 weeks
Title
Percentage of patients achieving DLQI 0/1 at week 12
Description
Dermatology Life Quality Index (DLQI) is calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80377
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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