Phase
Condition
Idiopathic Pulmonary Fibrosis
Lung Disease
Cystic Fibrosis
Treatment
Leramistat
MBS2320
Placebo
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmedby the investigator based on chest high-resolution computed tomography (hrCT) scantaken within 3 years of Screening and, if available, surgical lung biopsy b. UIP orprobable UIP hrCT pattern consistent with the clinical diagnosis of IPF, as confirmedby central review prior to baseline (if indeterminate, hrCT findings of IPF may beconfirmed locally by historical biopsy).
- Has an FVC ≥45% of predicted.
- Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted.
- Minimum distance on 6MWT of 150 meters.
- Has a FEV1/FVC ratio >0.70.
- If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone areallowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1
- Has a life expectancy of at least 12 months (in the opinion of the investigator).
- This list contains only key inclusion criteria.
Exclusion
Exclusion Criteria:
- Emphysema ≥50% on hrCT or the extent of emphysema is greater than the extent offibrosis according to the central reviewer's assessment from the most recent hrCT orif reported by the local reviewer.
- Any current malignancy or a history of malignancy within the previous 5 years prior toscreening, with the exception of adequately treated or excised non-metastatic basalcell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in theopinion of the Investigator increases the risk of participating in the study.
- Significant history of drug allergy, including to leramistat or excipients, asdetermined by the Investigator.
- Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome,toxic epidermal necrolysis or leukopenia)
- History of opportunistic, chronic, or recurrent infections.
- Participants with chronic obstructive pulmonary disease (COPD) or asthma that:
- require >2 maintenance therapies
- have experienced an exacerbation requiring hospitalization or systemiccorticosteroids within 12 months prior to screening.
- This list contains only key exclusion criteria.
Study Design
Study Description
Connect with a study center
Hopital Avicenne
Bobigny,
FranceSite Not Available
Hopital Nord AP-HM
Marseille,
FranceActive - Recruiting
Hôpital Pasteur II
Nice,
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris,
FranceSite Not Available
Hopital Robert Schuman
Vantoux,
FranceSite Not Available
Zentralklinik Bad Berka GmbH
Bad Berka,
GermanySite Not Available
Ruhrlandklinik
Essen,
GermanySite Not Available
IKF Pneumologie
Frankfurt am Main,
GermanySite Not Available
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main,
GermanySite Not Available
Universitätsklinikum Gießen und Marburg GmbH
Gießen,
GermanySite Not Available
Universitatsklinikum Halle (Saale)
Halle,
GermanySite Not Available
Klinikum Köln-Merheim
Köln,
GermanySite Not Available
Universitatsklinikum Leipzig
Leipzig,
GermanySite Not Available
Universitatsklinikum Schleswig-Holstein - Kiel
Lübeck,
GermanySite Not Available
University Hospital of Alexandroupolis
Alexandroupoli,
GreeceSite Not Available
Evangelismos General Hospital of Athens
Athens,
GreeceSite Not Available
General Hospital of Diseases Thoracos of Athens "Sotiria"
Athens,
GreeceSite Not Available
Sotiria Chest Hospital of Athens
Athens,
GreeceSite Not Available
University General Hospital of Heraklion
Heraklion,
GreeceSite Not Available
University General Hospital of Ioannina
Ioánnina,
GreeceSite Not Available
University General Hospital of Larissa
Larisa,
GreeceSite Not Available
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloníki,
GreeceSite Not Available
Semmelweis Egyetem
Budapest,
HungarySite Not Available
Mátrai Gyógyintézet
Gyöngyös,
HungarySite Not Available
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár,
HungarySite Not Available
Shamir Medical Center Assaf Harofeh
Be'er Ya'aqov,
IsraelSite Not Available
Lady Davis Carmel Medical Center
Haifa,
IsraelSite Not Available
Rambam Medical Center - PPDS
Haifa,
IsraelSite Not Available
Kaplan Medical Center
Reẖovot,
IsraelSite Not Available
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv-Yafo,
IsraelSite Not Available
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania,
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze,
ItalySite Not Available
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena,
ItalySite Not Available
Fondazione Policlinico Universitario A Gemelli-Rome
Roma,
ItalySite Not Available
Azienda Ospedaliera Universitaria Senese
Siena,
ItalySite Not Available
Hospital Puerta del Mar
Cadiz,
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia,
SpainSite Not Available
Royal Brompton Hospital
London,
United KingdomSite Not Available
University College Hospital
London,
United KingdomSite Not Available
North Manchester General Hospital - PPDS
Manchester,
United KingdomSite Not Available
Walsall Manor Hospital
Walsall,
United KingdomSite Not Available
UCSF Fresno
Fresno, California 93701-2302
United StatesSite Not Available
University of California, San Francisco Medical Center
San Francisco, California 94143-2204
United StatesSite Not Available
National Jewish Health Main Campus
Denver, Colorado 80206-2761
United StatesSite Not Available
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United StatesSite Not Available
Reliant Medical Research
Miami, Florida 33165
United StatesSite Not Available
US Associates in Research Inc
Miami, Florida 33175
United StatesSite Not Available
GCP Clinical Research
Tampa, Florida 33609-3589
United StatesSite Not Available
GCP Clinical Research, LLC
Tampa, Florida 33609-3589
United StatesSite Not Available
Southern Medical Research, LLC
Macon, Georgia 31201-8334
United StatesSite Not Available
GenHarp Clinical Solutions
Chicago, Illinois 60649-4718
United StatesSite Not Available
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana 47303-3432
United StatesSite Not Available
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana 70433-2353
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201-1544
United StatesSite Not Available
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland 21044-3081
United StatesSite Not Available
Reliant Medical Research
Worcester, Massachusetts 01605-2058
United StatesSite Not Available
Hudson County Clinical Trials Research Center
Union City, New Jersey 07087-3375
United StatesSite Not Available
Lovelace Scientific Resources Inc
Albuquerque, New Mexico 87108-5129
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710-4000
United StatesSite Not Available
Southeastern Research Center
Winston-Salem, North Carolina 27103-4029
United StatesActive - Recruiting
Medical University of South Carolina - PPDS
Charleston, South Carolina 29425-8900
United StatesSite Not Available
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee 37067-5663
United StatesSite Not Available
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas 75246-2073
United StatesSite Not Available
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr
McKinney, Texas 75069-1898
United StatesSite Not Available
Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr
McKinney, Texas 75069-1898
United StatesSite Not Available
University of Utah - PPDS
Salt Lake City, Utah 84108-1257
United StatesSite Not Available
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