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A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC 0602K in Patients With NASH (EMMINENCE)

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ClinicalTrials.gov Identifier: NCT02784444
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Cirius Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Hepatic histological improvement in NAS defined as a decrease of at least 2 points with no worsening of fibrosis stage at 12 months. [ Time Frame: 12 months (360 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
Hepatic histological improvement in NASH defined as a decrease in the NAS (NASH CRN scoring) by at least 2 points with no concurrent worsening of fibrosis at 12 months [ Time Frame: 12 months (360 days) ]
The reduction in NAS must include either a 1 point reduction in ballooning or inflammation. Worsening of fibrosis is evaluated using the NASH Clinical Research Network (CRN) fibrosis staging system and defined as progression of at least one stage.
Change History Complete list of historical versions of study NCT02784444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Proportion of subjects with resolution of NASH with no worsening of fibrosis at 12 months. [ Time Frame: 12 months (360 days) ]
  • Proportion of subjects with improvement of fibrosis (CRN staging score) by at least 1 stage with no worsening of NASH at 12 months. [ Time Frame: 12 months (360 days) ]
  • Mean change from baseline in NAFLD activity score (NAS) and each one of its components (steatosis, inflammation and ballooning) at 12 months. [ Time Frame: 12 months (360 days) ]
  • Mean change from baseline in fibrosis score at 12 months. [ Time Frame: 12 months (360 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months (360 days) ]
  • Proportion of patients that achieve resolution of NASH by hepatic histology at 12 months. [ Time Frame: 12 months (360 days) ]
    Resolution of NASH is defined as a ballooning score of 0 and an inflammation score of 0-1 without worsening of fibrosis.
  • Proportion of patients that achieve an improvement in liver fibrosis, determined by a reduction from baseline of at least one point by NASH CRN scoring at 12 months. [ Time Frame: 12 months (360 days) ]
  • Mean changes in the NAFLD activity score and each one of its components (steatosis, inflammation and ballooning) at 12 months. [ Time Frame: 12 months (360 days) ]
  • Mean changes from baseline in fibrosis score (NASH CRN scoring) at 12 months. [ Time Frame: 12 months (360 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC 0602K in Patients With NASH
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC 0602K in Patients With NASH (EMMINENCE™)
Brief Summary This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
Detailed Description

This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis. Visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12 months, with one 2- week follow-up visit.

Safety will be assessed by monitoring of vital signs, 12 lead electrocardiogram (ECG), physical examinations, safety labs, and adverse events (AEs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-alcoholic Fatty Liver Disease
  • Non-alcoholic Steatohepatitis
  • NASH - Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: MSDC-0602K
    MSDC-0602K capsules
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Active Comparator: MSDC-0602K Dose 1 capsules
    MSDC-0602K Dose 1 capsule taken once daily for 360 days
    Intervention: Drug: MSDC-0602K
  • Active Comparator: MSDC-0602K Dose 2 capsules
    MSDC-0602K Dose 2 capsules taken once daily for 360 days
    Intervention: Drug: MSDC-0602K
  • Active Comparator: MSDC-0602K Dose 3 capsules
    MSDC-0602K Dose 3 capsules taken once daily for 360 days
    Intervention: Drug: MSDC-0602K
  • Placebo Comparator: Placebo capsules
    Matching Placebo capsule taken once daily for 360 days
    Intervention: Drug: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
380
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
200
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Selected Inclusion Criteria:

  • Adult subjects 18 years of age or greater
  • Histological evidence of NASH, based on biopsy, with a NAS (NASH CRN scoring) ≥ 4 with a score of at least 1 in each component of NAS.
  • Histological evidence of liver fibrosis defined as NASH CRN System fibrosis score F1 to F3.
  • Subjects with type 2 diabetes mellitus (DM) must be under stable and reasonable control.
  • Male and female subjects who are taking Vitamin E should be on a stable dose of Vitamin E (if ≥ 400 IU) for a period of at least 3 months prior to randomization.
  • Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse.
  • Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

Selected Exclusion Criteria:

  • Known history of HIV.
  • Prior liver transplantation.
  • Other well-documented causes of active chronic liver disease.
  • History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding.
  • History of alcohol abuse or drug abuse within 6 months of Screening.
  • Type 1 diabetes mellitus.
  • Current or history of recent (≤ 6 months) use of ursodeoxycholic acid.
  • Use of concomitant medications with a known significant metabolism by CYP2C8 or CPY2C9.
  • History of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 6 months prior to randomization.
  • History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to randomization.
  • Blood pressure greater than 160/100 mmHg.
  • Participation in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
  • Malignancy, including leukemia and lymphoma (excluding basal cell and squamous skin cell cancers and localized prostrate cancer) treated within the last 2 years.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02784444
Other Study ID Numbers  ICMJE MSDC-0602K-C009NASH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cirius Therapeutics, Inc.
Study Sponsor  ICMJE Cirius Therapeutics, Inc.
Collaborators  ICMJE Chiltern International Inc.
Investigators  ICMJE
Study Director: Howard Dittrich, MD Cirius Therapeutics, Inc.
PRS Account Cirius Therapeutics, Inc.
Verification Date May 2018

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