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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237116
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Non-alcoholic Fatty Liver Disease Biological: Investigational Arm - secukinumab Biological: Control Arm - placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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)
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : May 24, 2021
Estimated Study Completion Date : February 11, 2022


Arm Intervention/treatment
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
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
Other Name: AIN457

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
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
Other Name: AIN457




Primary Outcome Measures :
  1. Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline [ Time Frame: 12 weeks ]
    Psoriasis Area and Severity Index (PASI) 90 response is defined as ≥ 90% improvement (reduction) in PASI score compared to Baseline


Secondary Outcome Measures :
  1. Serum Alanine Aminotransferase (ALT) level [ Time Frame: 12 weeks ]
    ALT is an enzyme that the liver releases when it becomes inflamed or damaged. ALT level measures liver function Parameter.

  2. Percentage of patients achieving DLQI 0/1 at week 12 [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237116


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Germany
Novartis Investigative Site Recruiting
Erlangen, Germany, 91054
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Recruiting
Lubeck, Germany, 23538
Novartis Investigative Site Recruiting
Muenchen, Germany, 81675
Novartis Investigative Site Recruiting
Potsdam, Germany, 14467
Novartis Investigative Site Recruiting
Stuttgart, Germany, 70178
Novartis Investigative Site Recruiting
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04237116    
Other Study ID Numbers: CAIN457ADE15
2019-003168-37 ( EudraCT Number )
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
plaque psoriasis
NAFLD
NASH
PASI
secukinumab
non-alcoholic fatty liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Digestive System Diseases