A Study to Investigate Leramistat in Patients With IPF

Phase 2

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebo; Drug: Leramistat

• Registration Number: NCT05951296
• Lead Sponsor: Modern Biosciences Ltd

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).

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 Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-19
• Study Start: 2023-08-30
• Primary Completion: 2024-02-27
• Study Completion: 2024-03-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator
Leramistat	Leramistat	Leramistat once daily

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	12 weeks	Change from baseline in FVC versus placebo up to Week 12

Trial Locations

Locations (56)

Reliant Medical Research; 🇺🇸 Miami, Florida, United States

Southern Medical Research, LLC; 🇺🇸 Macon, Georgia, United States

GenHarp Clinical Solutions; 🇺🇸 Chicago, Illinois, United States

UCSF Fresno; 🇺🇸 Fresno, California, United States

National Jewish Health Main Campus; 🇺🇸 Denver, Colorado, United States

GCP Clinical Research, LLC; 🇺🇸 Tampa, Florida, United States

GCP Clinical Research; 🇺🇸 Tampa, Florida, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

US Associates in Research Inc; 🇺🇸 Miami, Florida, 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

Hôpital Pasteur II; 🇫🇷 Nice, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hopital Robert Schuman; 🇫🇷 Vantoux, France

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Ruhrlandklinik; 🇩🇪 Essen, Germany

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

IKF Pneumologie; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinikum Gießen und Marburg GmbH; 🇩🇪 Gießen, Germany

Universitatsklinikum Halle (Saale); 🇩🇪 Halle, Germany

Klinikum Köln-Merheim; 🇩🇪 Köln, 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; 🇬🇷 Ioánnina, Greece

University General Hospital of Larissa; 🇬🇷 Larisa, Greece

Georgios Papanikolaou General Hospital of Thessaloniki; 🇬🇷 Thessaloníki, 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; 🇮🇱 Reẖovot, Israel

Tel Aviv Sourasky Medical Center - PPDS; 🇮🇱 Tel Aviv-Yafo, Israel

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, 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