A Study to Investigate Leramistat in Patients With IPF

NCT05951296 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: IST-072023-504418-30
• Study Type: interventional
• Target: N/A
• Locations: 9 countries
• Sites: 57

Brief 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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF

Outcome Measures

Primary Outcomes (1)

• Forced vital capacity (FVC)

  Change from baseline in FVC versus placebo up to Week 12

  12 weeks

Other Outcomes (1)

• Adverse effects

  12 Weeks

Study Arms (2)

Leramistat

EXPERIMENTAL

Leramistat once daily

Drug: Leramistat

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

Leramistat DRUG

Drug: Leramistat

Leramistat

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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 are allowed. 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).

You may not qualify if:

• 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.
• 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.
• 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.
• Significant history of drug allergy, including to leramistat or excipients, as determined 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 systemic corticosteroids within 12 months prior to screening.

Sponsors & Collaborators

• Modern Biosciences Ltd: lead

Study Sites (57)

UCSF Fresno

Fresno, California, 93701-2302, United States

Location

National Jewish Health Main Campus

Denver, Colorado, 80206-2761, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Reliant Medical Research

Miami, Florida, 33165, United States

Location

US Associates in Research Inc

Miami, Florida, 33175, United States

Location

GCP Clinical Research, LLC

Tampa, Florida, 33609-3589, United States

Location

GCP Clinical Research

Tampa, Florida, 33609-3589, United States

Location

Southern Medical Research, LLC

Macon, Georgia, 31201-8334, United States

Location

GenHarp Clinical Solutions

Chicago, Illinois, 60649-4718, United States

Location

IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

Muncie, Indiana, 47303-3432, United States

Location

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, 70433-2353, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201-1544, United States

Location

Howard County Center for Lung and Sleep Medicine, LLC

Columbia, Maryland, 21044-3081, United States

Location

Howard County Center for Lung and Sleep Medicine, LLC

Columbia, Maryland, 21045-5422, United States

Location

Hudson County Clinical Trials Research Center

Union City, New Jersey, 07087-3375, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710-4000, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103-4029, United States

Location

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

Dallas, Texas, 75246-2073, United States

Location

Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr

McKinney, Texas, 75069-1898, United States

Location

Metroplex Pulmonary and Sleep Medicine Centre 4833 Medical Center Dr

McKinney, Texas, 75069-1898, United States

Location

University of Utah - PPDS

Salt Lake City, Utah, 84108-1257, United States

Location

Hopital Nord AP-HM

Marseille, France

Location

Hôpital Pasteur II

Nice, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hopital Robert Schuman

Vantoux, France

Location

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Location

Klinikum Köln-Merheim

Cologne, Germany

Location

Ruhrlandklinik

Essen, Germany

Location

IKF Pneumologie

Frankfurt am Main, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, Germany

Location

Universitatsklinikum Halle (Saale)

Halle, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Germany

Location

Universitatsklinikum Schleswig-Holstein - Kiel

Lübeck, Germany

Location

University Hospital of Alexandroupolis

Alexandroupoli, Greece

Location

Evangelismos General Hospital of Athens

Athens, Greece

Location

General Hospital of Diseases Thoracos of Athens "Sotiria"

Athens, Greece

Location

University General Hospital of Heraklion

Heraklion, Greece

Location

University General Hospital of Ioannina

Ioannina, Greece

Location

University General Hospital of Larissa

Larissa, Greece

Location

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

Location

Lady Davis Carmel Medical Center

Haifa, Israel

Location

Rambam Medical Center - PPDS

Haifa, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Tel Aviv Sourasky Medical Center - PPDS

Tel Aviv, Israel

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Italy

Location

Fondazione Policlinico Universitario A Gemelli-Rome

Roma, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Hospital Puerta del Mar

Cadiz, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Royal Brompton Hospital

London, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

North Manchester General Hospital - PPDS

Manchester, United Kingdom

Location

Walsall Manor Hospital

Walsall, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 19, 2023
• Study Start: August 30, 2023
• Primary Completion: February 27, 2024
• Study Completion: March 14, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (21); FR (4); HU (2); DE (8); ES (2); GB (4); IL (4); GR (7); IT (5)