New drug MN-001 tested for scarred lungs in tiny trial
NCT ID NCT02503657
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an experimental drug called MN-001 (tipelukast) in 15 people with moderate to severe idiopathic pulmonary fibrosis (IPF), a lung-scarring disease. Participants took either the drug or a placebo twice daily for six months, then everyone could take the drug for another six months. The goal was to see if MN-001 could slow the decline in lung function and check its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MN-001 (tipelukast)
- What this could lead to
- If it works, this could point toward a treatment that slows lung function decline in people with IPF.
- What could go wrong
- This is a very small early-phase trial with only 15 participants, so results may not be reliable or apply to everyone. The drug may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Mar 2016
- Finished
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Mar 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Penn State University College of Medicine, Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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