A Study to Investigate Leramistat in Patients With IPF

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of Leramistat in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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).

Study Overview

• Status: Withdrawn
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: Leramistat

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Hopital Nord AP-HM
  • Nice, France
    • Hopital Pasteur II
  • Paris, France
    • Hôpital Européen Georges Pompidou
  • Vantoux, France
    • Hopital Robert Schuman
• Germany
  • Bad Berka, Germany
    • Zentralklinik Bad Berka GmbH
  • Essen, Germany
    • Ruhrlandklinik
  • Frankfurt am Main, Germany
    • IKF Pneumologie
  • Gießen, Germany
    • Universitätsklinikum Gießen und Marburg GmbH
  • Halle, Germany
    • Universitatsklinikum Halle (Saale)
  • Köln, Germany
    • Klinikum Köln-Merheim
  • Leipzig, Germany
    • Universitätsklinikum Leipzig
  • Lübeck, Germany
    • Universitatsklinikum Schleswig-Holstein - Kiel
• Greece
  • Alexandroupoli, Greece
    • University Hospital of Alexandroupolis
  • Athens, Greece
    • Evangelismos General Hospital of Athens
  • Athens, Greece
    • General Hospital of Diseases Thoracos of Athens "Sotiria"
  • Heraklion, Greece
    • University General Hospital of Heraklion
  • Ioánnina, Greece
    • University General Hospital of Ioannina
  • Larisa, Greece
    • University General Hospital of Larissa
  • Thessaloníki, Greece
    • Georgios Papanikolaou General Hospital of Thessaloniki
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem
  • Székesfehérvár, Hungary
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Israel
  • Haifa, Israel
    • Lady Davis Carmel Medical Center
  • Haifa, Israel
    • Rambam Medical Center - PPDS
  • Reẖovot, Israel
    • Kaplan Medical Center
  • Tel Aviv-Yafo, Israel
    • Tel Aviv Sourasky Medical Center - PPDS
• Italy
  • Catania, Italy
    • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Firenze, Italy
    • Azienda Ospedaliera Universitaria Careggi
  • Modena, Italy
    • Azienda Ospedaliero Universitaria Di Modena Policlinico
  • Roma, Italy
    • Fondazione Policlinico Universitario A Gemelli-Rome
  • Siena, Italy
    • Azienda Ospedaliera Universitaria Senese
• Spain
  • Cadiz, Spain
    • Hospital Puerta del Mar
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
• United Kingdom
  • London, United Kingdom
    • Royal Brompton Hospital
  • London, United Kingdom
    • University College Hospital
  • Manchester, United Kingdom
    • North Manchester General Hospital - PPDS
  • Walsall, United Kingdom
    • Walsall Manor Hospital
• United States
  • California
    • Fresno, California, United States, 93701-2302
      • UCSF Fresno
  • Colorado
    • Denver, Colorado, United States, 80206-2761
      • National Jewish Health Main Campus
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33165
      • Reliant Medical Research
    • Miami, Florida, United States, 33175
      • US Associates in Research Inc
    • Tampa, Florida, United States, 33609-3589
      • GCP Clinical Research
    • Tampa, Florida, United States, 33609-3589
      • GCP Clinical Research, LLC
  • Georgia
    • Macon, Georgia, United States, 31201-8334
      • Southern Medical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60649-4718
      • GenHarp Clinical Solutions
  • Indiana
    • Muncie, Indiana, United States, 47303-3432
      • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
  • Louisiana
    • Covington, Louisiana, United States, 70433-2353
      • Benchmark Research - Covington - HyperCore - PPDS
  • Maryland
    • Baltimore, Maryland, United States, 21201-1544
      • University of Maryland Medical Center
    • Columbia, Maryland, United States, 21044-3081
      • Howard County Center for Lung and Sleep Medicine, LLC
    • Columbia, Maryland, United States, 21045-5422
      • Howard County Center for Lung and Sleep Medicine, LLC
  • New Jersey
    • Union City, New Jersey, United States, 07087-3375
      • Hudson County Clinical Trials Research Center
  • North Carolina
    • Durham, North Carolina, United States, 27710-4000
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103-4029
      • Southeastern Research Center
  • Texas
    • Dallas, Texas, United States, 75246-2073
      • Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
    • McKinney, Texas, United States, 75069-1898
      • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr
    • McKinney, Texas, United States, 75069-1898
      • Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr
  • Utah
    • Salt Lake City, Utah, United States, 84108-1257
      • University of UTAH - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmed by the investigator based on chest high-resolution computed tomography (hrCT) scan taken within 3 years of Screening and, if available, surgical lung biopsy b. UIP or probable UIP hrCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to baseline (if indeterminate, hrCT findings of IPF may be confirmed 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 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).

   • This list contains only key inclusion criteria.

Exclusion Criteria:

1. Emphysema ≥50% on hrCT or the extent of emphysema is greater than the extent of fibrosis according to the central reviewer's assessment from the most recent hrCT or if reported by the local reviewer.
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.

     • This list contains only key exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo comparator	Drug: Placebo; Placebo comparator
Experimental: Leramistat; Leramistat once daily	Drug: Leramistat; Drug: Leramistat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity (FVC)	Change from baseline in FVC versus placebo up to Week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% predicted FVC	Change from baseline in %FVC up to Week 12	12 Weeks
%DLCO	Change from baseline in %DLCO up to Week 12	12 Weeks
Acute exacerbations	Time to first acute exacerbation up to Week 12.	12 Weeks
Forced expiratory volume	Forced expiratory volume in 1 second (FEV1)	12 Weeks
Disease progression	Decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.	12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Incidence and frequency of treatment-emergent adverse events	12 Weeks

Collaborators and Investigators

• Sponsor: Modern Biosciences Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: IPF
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: IST-07; 2023-504418-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No