Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-08-30
2024-03-14
Brief Summary
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Detailed Description
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Screening period: 1 to 28 days (Weeks -4 to -1). Treatment period: a 12-week blinded, placebo-controlled treatment period (Weeks 1 to 12).
Follow up period: 56 days (Weeks 13 to 20). All participants will return for a follow-up visit 56 days after their final dose.
Randomization will be stratified by concomitant use of an approved anti-fibrotic drug (nintedanib or pirfenidone) at randomization versus no concomitant use of an approved anti-fibrotic drug at randomization.
Number of Participants: Approximately 150 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either leramistat or matched placebo.
If the participant is receiving nintedanib or pirfenidone treatment, it should be stable for at least 8 weeks prior to study entry and be predicted to remain stable during the course of the study. The maximum duration of participation (including screening period and follow-up) is 24 weeks.
Data Monitoring/Other Committee: A DSMB has been appointed for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Leramistat
Leramistat once daily
Leramistat
Drug: Leramistat
Placebo
Placebo comparator
Placebo
Placebo comparator
Interventions
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Leramistat
Drug: Leramistat
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
2. Has an FVC ≥45% of predicted.
3. Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted.
4. Minimum distance on 6MWT of 150 meters.
5. Has a FEV1/FVC ratio \>0.70.
6. If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1
7. Has a life expectancy of at least 12 months (in the opinion of the investigator).
Exclusion Criteria
2. Any current malignancy or a history of malignancy within the previous 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
3. Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study.
4. Significant history of drug allergy, including to leramistat or excipients, as determined by the Investigator.
5. Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis or leukopenia)
6. History of opportunistic, chronic, or recurrent infections.
7. Participants with chronic obstructive pulmonary disease (COPD) or asthma that:
* require \>2 maintenance therapies
* have experienced an exacerbation requiring hospitalization or systemic corticosteroids within 12 months prior to screening.
40 Years
ALL
No
Sponsors
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Modern Biosciences Ltd
INDUSTRY
Responsible Party
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Locations
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UCSF Fresno
Fresno, California, United States
National Jewish Health Main Campus
Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Reliant Medical Research
Miami, Florida, United States
US Associates in Research Inc
Miami, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Southern Medical Research, LLC
Macon, Georgia, United States
GenHarp Clinical Solutions
Chicago, Illinois, United States
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana, United States
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, United States
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas, United States
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr
McKinney, Texas, United States
Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr
McKinney, Texas, United States
University of Utah - PPDS
Salt Lake City, Utah, United States
Hopital Nord AP-HM
Marseille, , France
Hôpital Pasteur II
Nice, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hopital Robert Schuman
Vantoux, , France
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Klinikum Köln-Merheim
Cologne, , Germany
Ruhrlandklinik
Essen, , Germany
IKF Pneumologie
Frankfurt am Main, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Universitatsklinikum Halle (Saale)
Halle, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Universitatsklinikum Schleswig-Holstein - Kiel
Lübeck, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Evangelismos General Hospital of Athens
Athens, , Greece
General Hospital of Diseases Thoracos of Athens "Sotiria"
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
University General Hospital of Larissa
Larissa, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Lady Davis Carmel Medical Center
Haifa, , Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, , Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Royal Brompton Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
North Manchester General Hospital - PPDS
Manchester, , United Kingdom
Walsall Manor Hospital
Walsall, , United Kingdom
Countries
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Other Identifiers
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2023-504418-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IST-07
Identifier Type: -
Identifier Source: org_study_id
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