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Idiopathic Pulmonary FibrosisPhase 2NCT02503657

Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2 study testing MN-001 in people with Idiopathic Pulmonary Fibrosis and IPF, run by MediciNova at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis, IPF
What is being tested?
MN-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
9 Mar 2016to 15 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State University College of Medicine, Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: 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)

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 patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants were randomly assigned to receive MN-001 or matching placebo twice daily over a 26-week period. A total of 15 participants were enrolled.

Read the detailed description

This study was a single-center, randomized (2:1), placebo-controlled, double-blind, 6-month study followed by a 6-month open-label extension (OLE) phase in patients with moderate to severe IPF. Major inclusion criteria: physician diagnosed IPF (ATS Guidelines, 2011), males and females aged 21 to 80 years, GAP Stage II-III; on no anti-fibrotic treatment. Patients on stable dose of nintedanib for at least 3 months prior to the study were allowed.

The study consisted of a Screening Phase (up to 3 months prior to Day1), a 26- week Double-Blind Treatment (DBT) period, a 26-week Open-Label Extension (OLE) period, and a Follow-up / End of Study Visit (within 4 weeks of the last dose taken).

A total of 15 patients were enrolled in the study. During the DBT period, participants were randomly assigned to receive MN-001 750 mg twice daily or a matching placebo in a 2:1 ratio (MN-001: placebo) for 26 weeks. During the OLE period, all participants received MN-001 750 mg twice daily for 26 weeks. Taken together, participants (n=15) received either MN-001 50 mg twice daily for 12 months (MN-001/MN-001) or matching placebo for 6 months and MN-001 750 mg twice daily for 6 months (Placebo/MN-001).

Being tested
MN-001, Placebo
Keywords
tipelukast, IPF, fibrosis, Idiopathic Pulmonary Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MN-001Drug

    Also called Tipelukast

    A novel, orally bioavailable small molecule compound that demonstrates anti-inflammatory and anti-fibrotic activity

  • PlaceboDrug

    Excipients of MN-001/tipelukast

Study groups in NCT02503657
Study groupRoleWhat they receive
MN-001 in Double-blind period for 26 weeks, then MN-001 in Open-Label period for 26 weeksExperimentalMN-001 750 mg twice a day during the double-blind period (26 weeks) and MN-001 750 mg twice a day during the open-label period for 26 weeks. The arm title is shortened to MN-001/MN-001 for all results sections.
Receives: Drug: MN-001
Placebo during Double-blind period for 26 weeks, then MN-001 in Open-Label period for 26 weeksPlacebo comparatorPlacebo twice a day during the double-blind period for 26 weeks and MN-001 750 mg twice daily during the open-label period for 26 weeks. The arm title is shortened to Placebo/MN-001 for all results sections.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change From Baseline in Forced Vital Capacity for 26 Weeks

    Predicted forced vital capacity (FVC) is a reference value for lung function based on your age, height, sex, and ethnicity measured by a spirometer and is an established method of pulmonary function. FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L).

    Measured: Baseline and Week 26 at the end of Double-blind treatment period.

  2. Percent Change in Forced Vital Capacity From Baseline to Week 26

    FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L). The mean relative change was calculated as 100*[FVC (L) at Week 26 - FVC (L) at baseline].

    Measured: Baseline, and Week 26 at the endpoint of the Double-blind treatment period.

  3. Absolute Change From Baseline in Forced Vital Capacity (% Predicted)

    FVC(%pred.) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment.

    Measured: Baseline and Week 26 at the end of Double-blind treatment period.

  4. Relative Change From Baseline in Percent Predicted Forced Vital Capacity From Baseline to Week 26

    FVC (%pred/) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment. Relative change is measured as percent (%) change from FVC (%pred.).

    Measured: Baseline and Week 26 at the end of Double-blind treatment period.

  5. Semiannual Rate of Decline of Disease Activity Based on Forced Vital Capacity

    The semiannual rates of change in FVC, measured in liters, were estimated using simple linear regression, with time measured in half-years.

    Measured: Baseline and Week 26 at the end of Double-blind treatment period.

Secondary outcomes (4)

  1. Number of Participants With Treatment-related Serious Adverse Events.

    Treatment-related serious adverse events (TRSAEs) are defined as possibly related, probably related, or related to MN-001 treatment.

    Measured: Baseline, and Week 26 at the endpoint of the Double-blind treatment period

  2. Change From Baseline on Disease Activity Based on Modified Medical Research Council Dyspnea Score

    The Modified Medical Research Council Dyspnea Score is a simple grading system widely used in the assessment of dyspnea (difficulty breathing) in chronic respiratory diseases, such as IPF. The breathlessness scale comprises five statements that cover respiratory disability from 0 (zero) to 4, in which 0 = not troubled by breathlessness, except on strenuous exercise, 1= shortness of breath when hurrying on the level or walking up a slight hill, 2 = walks slower than people of the same age or has to stop for breath when walking at own pace on level ground, 3 = stops for breath after walking just 100 meters (100 yards) or after a few minutes, and 4 = too breathless to leave the house or breathless when dressing or undressing. A higher score corresponds to greater difficult in breathing.

    Measured: Baseline, and Week 26 at the endpoint of the Double-blind treatment period

  3. Change From Baseline on Quality of Life (QOL) Measured by A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis

    The A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis score is a quality-of-life questionnaire that has 13 domains (cough, dyspnea, forethought, sleep, mortality, exhaustion, emotional well-being, social participation, finances, independence, sexual health, relationships, therapy). The domain scores and the Total score from these domain scores are calculated by summation. Higher scores correspond to greater impairment. The Total score ranges from 74 to 370.

    Measured: Baseline, and Week 26 at the endpoint of the Double-blind treatment period

  4. Frequency of Worsening IPF

    The number of participants who experienced worsening in IPF. Worsening of IPF is defined as acute IPF exacerbation, hospitalization due to respiratory symptoms, IPF-related fatal events, and/or lung transplantation.

    Measured: Baseline, and Week 26 at the endpoint of the Double-blind treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2015 (estimated)
  2. Study start9 Mar 2016
  3. Primary completion7 Dec 2020
  4. Study completion15 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study evaluated the efficacy, safety, and tolerability of MN-001 in male and female patients aged 21 to 80 years, inclusive, with moderate-to-severe idiopathic pulmonary fibrosis (IPF). Fifteen (15) participants received MN-001 750 mg or a matching placebo twice daily for 26 weeks in a 2:1 (MN-001:Placebo) ratio. The study consisted of a Screening period (up to 3 months before baseline), a 26-week double-blind treatment (DBT) period, a 26-week open-label (OL) treatment period, and a follow-up visit (within 4 weeks after the last dose). Efficacy results are reported only for the DBT period. Safety findings are reported from Baseline (Day 1 of MN-001 or placebo treatment) to the end of the Open-Label period (52 weeks total).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02503657
Sponsor's protocol ID
MN-001-IPF-201
Status last verified
Jan 2026
First submitted
14 Jul 2015
Last updated
23 Jan 2026
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MN-001 in people with Idiopathic Pulmonary Fibrosis and IPF, run by MediciNova at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Forced Vital Capacity for 26 Weeks (time frame: Baseline and Week 26 at the end of Double-blind treatment period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02503657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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