Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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: NCT02503657
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
MediciNova

Tracking Information
First Submitted Date  ICMJE July 14, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date May 31, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
Change from baseline of FVC (forced vital capacity) at 26 weeks [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02503657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • The safety of MN-001 in subjects with IPF assessed by number of adverse events experienced by each participant [ Time Frame: Subjects will return to the clinic at Months 1, 3, 6, and will be followed by telephone at Week 1 and Month 4 ]
  • Tolerability of MN-001 in subjects with IPF assessed by number of adverse events experienced by each participant [ Time Frame: Subjects will return to the clinic at Months 1, 3, and 6 and will be followed by telephone at Week 1 and Month 4 ]
  • Rate of decline on disease activity based on the 6-minute walk test [ Time Frame: The rate of decline on disease activity will be assessed at the 26-week visit ]
  • Change from baseline on disease activity based on Modified Medical Research Council Dyspnea Score (MMRC) [ Time Frame: The change from baseline on disease activity will be assessed at the 26-week visit ]
  • Change from baseline on quality of life (QOL) measured by A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) [ Time Frame: The change from baseline on QOL will be assessed at the 26-week visit ]
  • Frequency of worsening IPF based on 6-minute walk test score [ Time Frame: Worsening of IPF will be assessed at Screening, Month 3, Month 6, Month 9 and Month 12. ]
  • Frequency of worsening IPF based on Modified Medical Research Council Dyspnea Score (MMRC) [ Time Frame: Frequency of worsening IPF will be assessed at Screening, Month 3, Month 6, Month 9 and Month 12. ]
  • Time to first worsening IPF based on MMRC score [ Time Frame: Time to first worsening IPF will be assessed at Screening, Month 3, Month 6, Month 9 and Month 12. ]
  • Time to first worsening IPF based on 6MWT score [ Time Frame: Time to first worsening IPF will be assessed at Screening, Month 3, Month 6, Month 9 and Month 12. ]
  • Change from baseline of FVC (forced vital capacity) % predicted at 26 weeks [ Time Frame: Change from baseline of FVC will be measured at 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary

This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will consist of males and females ranging in age from 21 to 80 years old, inclusive.

The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26 week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up Visit (within 4 weeks after the last dose).

Detailed Description Not Provided
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
  • Idiopathic Pulmonary Fibrosis
  • IPF
Intervention  ICMJE
  • Drug: tipelukast
    A novel, orally bioavailable small molecule compound that demonstrates anti-inflammatory and anti-fibrotic activity
    Other Name: MN-001
  • Drug: Placebo
    Excipients of MN-001/tipelukast
Study Arms  ICMJE
  • Placebo Comparator: Double-Blind Treatment

    Subjects who complete all of the screening assessments and meet all inclusion/exclusion criteria will be started on MN-001 (tipelukast) 750 mg or matching placebo bid. Subjects will return to the clinic on Treatment Day 1 to receive their first dose of study medication. Subsequently, subjects will return to the clinic on a regular basis for 26 weeks.

    During the Treatment Phase, safety and efficacy parameters will be assessed and concomitant medications will be documented. The safety and tolerability of MN-001 will be evaluated by an Independent Safety Monitor during this phase.

    Interventions:
    • Drug: tipelukast
    • Drug: Placebo
  • Open-Label Extension
    Upon completion of the Double-blind Treatment Phase, subjects who were taking placebo, will participate in the open-label extension (OLE) phase for an additional 6 months. Subjects randomized to the MN-001 (tipelukast) group will continue the study drug for additional 6 months.
    Intervention: Drug: tipelukast
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: July 17, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects ages 21 to 80, inclusive
  • Presence of IPF confirmed per ATS criteria (2011)
  • Presence of moderate to severe disease, stage II-III defined by GAP index (Gender, Age and Physiology)
  • Subjects who are currently treated with OFEV™/Nintedanib should be on a stable dose for at least 3 months prior to initiation of the study drug.
  • Females of child-bearing potential must have a negative serum ß-hCG (human chorionic gonadotropin) at screening and must be willing to use appropriate contraception (as defined by the investigator) for the duration of study treatment and 30 days after the last dose of study treatment.
  • Males should practice contraception for the duration of study treatment and 30 days after the last dose of study treatment as follows: condom use and contraception by female partner.
  • Subject is in stable condition on the basis of medical history, physical examination, and laboratory screening, as determined by the investigator.
  • Subject is willing and able to comply with the protocol assessments and visits, in the opinion of the study nurse/coordinator and the Investigator.
  • Written informed consent is obtained prior to participating the study.

Exclusion Criteria:

  • Expected to receive a lung transplant within 1 year from the start of the Treatment Phase or on a lung transplant waiting list at the start of the Treatment Phase.
  • Known explanation for interstitial lung disease
  • Subjects on OFEV™/Nintedanib with a dose interruption due to significant adverse events within 6 weeks of screening visits.
  • Ongoing IPF treatments with investigational therapy
  • Ongoing IPF treatments with Esbriet® (Pirfenidone)
  • Immunosuppressants (i.e., Mycophenolate, Imuran, Cyclophosphamide), and cytokine modulating agents within 1 month of Screening Visit and throughout the study
  • Use of antibiotics and systemic steroids due to IPF exacerbation within 1 month of Screening Visit
  • Clinically significant cardiovascular disease, including myocardial infarct within last 6 months, unstable ischemic heart disease, congestive heart failure or angina
  • Resting pulse < 50 bpm, SA (sinoatrial) or AV (atrioventricular) block, uncontrolled hypertension, or QTcF (QT interval corrected using the Fridericia formula) > 450 ms
  • Immune system disease
  • Any significant laboratory abnormality which, in the opinion of the Investigator, may put the subject at risk
  • History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • History or evidence of drug or alcohol abuse
  • History of HIV (human immunodeficiency virus) or other active infection.
  • Currently has a clinically significant medical condition including the following: neurological, psychiatric, immunological, metabolic, hepatic, hematological, pulmonary (other than IPF) , cardiovascular (including uncontrolled hypertension), gastrointestinal, urological disorder, or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if, in the judgment of the Investigator, they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted.

  • CYP2C8 (cytochrome P450 isoenzyme C28) and CYP2C9 (cytochrome P450 isoenzyme C29) substrates with narrow therapeutic indices (i.e. paclitaxel, phenytoin and S-warfarin) within 14 days of Screening Visit and throughout the study.
  • Beta blockers within 14 days of Screening Visit and throughout the study
  • Macrolide or quinolone class antibiotics within 14 days of Screening Visit and throughout the study.
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
  • Currently participating, or has participated in, a study with an investigational or marketed compound or device within 3 months prior to signing the informed consent.
  • Unwilling or unable to conduct Spirometry (Vital Capacity) test.
  • Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator, or is planning to relocate during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kim Hitz, RN 7175314924 khitz1@pennstatehealth.psu.edu
Contact: Joanna Dojillo, MD 8583731500 ext 118 dojillo@medicinova.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503657
Other Study ID Numbers  ICMJE MN-001-IPF-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MediciNova
Study Sponsor  ICMJE MediciNova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca Bascom, MD PSU Research, Department of Medicine
PRS Account MediciNova
Verification Date May 2019

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