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Trial record 3 of 3 for:    Novartis | Recruiting, Not yet recruiting Studies | NASH

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 : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 20, 2020
First Posted Date  ICMJE January 23, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
Percentage of participants achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline [ Time Frame: 12 weeks ]
PASI 90 response is defined as ≥ 90% improvement (reduction) in PASI score compared to Baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • Serum Alanine Aminotransferase (ALT) level [ Time Frame: 12 weeks ]
    ALT level measures liver function parameter
  • 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. It was pre-specified that results would be presented for all patients, not by cohort
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Plaque Psoriasis
  • Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: Investigational Arm - secukinumab
  • 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
    Intervention: Biological: Control Arm - placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 11, 2022
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04237116
Other Study ID Numbers  ICMJE CAIN457ADE15
2019-003168-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP