A Study to Investigate Leramistat in Patients With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951296
• Other study ID #: IST-07
• Secondary ID: 2023-504418-30
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Modern Biosciences Ltd
• Contact: Clinical Operations
• Phone: +44 (0)207 444 0066
• Email: ist07[@]istesso.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Leramistat
Drug: Leramistat
• Placebo
Placebo comparator

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	Hopital Nord AP-HM	Marseille
France	Hôpital Pasteur II	Nice
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Robert Schuman	Vantoux
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Ruhrlandklinik	Essen
Germany	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
Greece	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
Hungary	Semmelweis Egyetem	Budapest
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Rambam Medical Center - PPDS	Haifa
Israel	Kaplan Medical Center	Re?ovot
Israel	Tel Aviv Sourasky Medical Center - PPDS	Tel Aviv-Yafo
Italy	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
Spain	Hospital Puerta del Mar	Cadiz
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	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 States	University of Maryland Medical Center	Baltimore	Maryland
United States	GenHarp Clinical Solutions	Chicago	Illinois
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	Benchmark Research - Covington - HyperCore - PPDS	Covington	Louisiana
United States	Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas	Dallas	Texas
United States	National Jewish Health Main Campus	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	UCSF Fresno	Fresno	California
United States	Southern Medical Research, LLC	Macon	Georgia
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	Reliant Medical Research	Miami	Florida
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	University of Utah - PPDS	Salt Lake City	Utah
United States	GCP Clinical Research	Tampa	Florida
United States	GCP Clinical Research, LLC	Tampa	Florida
United States	Hudson County Clinical Trials Research Center	Union City	New Jersey
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Modern Biosciences Ltd

Countries where clinical trial is conducted

United States,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biomarkers in serum and plasma	hsCRP	12 Weeks
Other	Plasma pharmacokinetics	Plasma concentrations in ng/ml	12 Weeks
Other	Adverse effects	Incidence and frequency of treatment-emergent adverse events	12 Weeks
Primary	Forced vital capacity (FVC)	Change from baseline in FVC versus placebo up to Week 12	12 weeks
Secondary	% predicted FVC	Change from baseline in %FVC up to Week 12	12 Weeks
Secondary	%DLCO	Change from baseline in %DLCO up to Week 12	12 Weeks
Secondary	Acute exacerbations	Time to first acute exacerbation up to Week 12.	12 Weeks
Secondary	Forced expiratory volume	Forced expiratory volume in 1 second (FEV1)	12 Weeks
Secondary	Disease progression	Decline in %FVC =10%, decline in %DLCO =15%, lung transplantation, or death.	12 Weeks