A Study to Investigate Leramistat in Patients With IPF

Last updated: February 16, 2024
Sponsor: Modern Biosciences Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Lung Disease

Cystic Fibrosis

Treatment

Leramistat

MBS2320

Placebo

Clinical Study ID

NCT05951296
IST-07
2023-504418-30
  • Ages > 40
  • All Genders

Study Summary

To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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).
  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 areallowed. 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).
  • This list contains only key inclusion criteria.

Exclusion

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Significant history of drug allergy, including to leramistat or excipients, asdetermined 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 systemiccorticosteroids within 12 months prior to screening.
  • This list contains only key exclusion criteria.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Leramistat
Phase: 2
Study Start date:
August 30, 2023
Estimated Completion Date:
September 30, 2024

Study Description

This will be a Phase 2, double-blind, placebo-controlled, 2-arm, parallel-group, multi-centre study to investigate leramistat treatment of patients aged 40 years or older with IPF. The study is planned to consist of the following parts:

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.

Connect with a study center

  • Hopital Avicenne

    Bobigny,
    France

    Site Not Available

  • Hopital Nord AP-HM

    Marseille,
    France

    Active - Recruiting

  • Hôpital Pasteur II

    Nice,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • Hopital Robert Schuman

    Vantoux,
    France

    Site Not Available

  • Zentralklinik Bad Berka GmbH

    Bad Berka,
    Germany

    Site Not Available

  • Ruhrlandklinik

    Essen,
    Germany

    Site Not Available

  • IKF Pneumologie

    Frankfurt am Main,
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main,
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Gießen,
    Germany

    Site Not Available

  • Universitatsklinikum Halle (Saale)

    Halle,
    Germany

    Site Not Available

  • Klinikum Köln-Merheim

    Köln,
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein - Kiel

    Lübeck,
    Germany

    Site Not Available

  • University Hospital of Alexandroupolis

    Alexandroupoli,
    Greece

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens,
    Greece

    Site Not Available

  • General Hospital of Diseases Thoracos of Athens "Sotiria"

    Athens,
    Greece

    Site Not Available

  • Sotiria Chest Hospital of Athens

    Athens,
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion,
    Greece

    Site Not Available

  • University General Hospital of Ioannina

    Ioánnina,
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larisa,
    Greece

    Site Not Available

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloníki,
    Greece

    Site Not Available

  • Semmelweis Egyetem

    Budapest,
    Hungary

    Site Not Available

  • Mátrai Gyógyintézet

    Gyöngyös,
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár,
    Hungary

    Site Not Available

  • Shamir Medical Center Assaf Harofeh

    Be'er Ya'aqov,
    Israel

    Site Not Available

  • Lady Davis Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center - PPDS

    Haifa,
    Israel

    Site Not Available

  • Kaplan Medical Center

    Reẖovot,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center - PPDS

    Tel Aviv-Yafo,
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Senese

    Siena,
    Italy

    Site Not Available

  • Hospital Puerta del Mar

    Cadiz,
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • University College Hospital

    London,
    United Kingdom

    Site Not Available

  • North Manchester General Hospital - PPDS

    Manchester,
    United Kingdom

    Site Not Available

  • Walsall Manor Hospital

    Walsall,
    United Kingdom

    Site Not Available

  • UCSF Fresno

    Fresno, California 93701-2302
    United States

    Site Not Available

  • University of California, San Francisco Medical Center

    San Francisco, California 94143-2204
    United States

    Site Not Available

  • National Jewish Health Main Campus

    Denver, Colorado 80206-2761
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Reliant Medical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • US Associates in Research Inc

    Miami, Florida 33175
    United States

    Site Not Available

  • GCP Clinical Research

    Tampa, Florida 33609-3589
    United States

    Site Not Available

  • GCP Clinical Research, LLC

    Tampa, Florida 33609-3589
    United States

    Site Not Available

  • Southern Medical Research, LLC

    Macon, Georgia 31201-8334
    United States

    Site Not Available

  • GenHarp Clinical Solutions

    Chicago, Illinois 60649-4718
    United States

    Site Not Available

  • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

    Muncie, Indiana 47303-3432
    United States

    Site Not Available

  • Benchmark Research - Covington - HyperCore - PPDS

    Covington, Louisiana 70433-2353
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • Howard County Center for Lung and Sleep Medicine, LLC

    Columbia, Maryland 21044-3081
    United States

    Site Not Available

  • Reliant Medical Research

    Worcester, Massachusetts 01605-2058
    United States

    Site Not Available

  • Hudson County Clinical Trials Research Center

    Union City, New Jersey 07087-3375
    United States

    Site Not Available

  • Lovelace Scientific Resources Inc

    Albuquerque, New Mexico 87108-5129
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710-4000
    United States

    Site Not Available

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103-4029
    United States

    Active - Recruiting

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina 29425-8900
    United States

    Site Not Available

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee 37067-5663
    United States

    Site Not Available

  • Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas

    Dallas, Texas 75246-2073
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr

    McKinney, Texas 75069-1898
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr

    McKinney, Texas 75069-1898
    United States

    Site Not Available

  • University of Utah - PPDS

    Salt Lake City, Utah 84108-1257
    United States

    Site Not Available

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