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A Study to Investigate Leramistat in Patients With IPF

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ClinicalTrials.gov Identifier: NCT05951296
Recruitment Status : Recruiting
First Posted : July 19, 2023
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Modern Biosciences Ltd

Study Description
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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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Leramistat Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Leramistat
Leramistat once daily
 Drug: Leramistat
Drug: Leramistat
Placebo Comparator: Placebo
Placebo comparator
 Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Forced vital capacity (FVC) [ Time Frame: 12 weeks ]
    Change from baseline in FVC versus placebo up to Week 12


Secondary Outcome Measures :
  1. % predicted FVC [ Time Frame: 12 Weeks ]
    Change from baseline in %FVC up to Week 12

  2. %DLCO [ Time Frame: 12 Weeks ]
    Change from baseline in %DLCO up to Week 12

  3. Acute exacerbations [ Time Frame: 12 Weeks ]
    Time to first acute exacerbation up to Week 12.

  4. Forced expiratory volume [ Time Frame: 12 Weeks ]
    Forced expiratory volume in 1 second (FEV1)

  5. Disease progression [ Time Frame: 12 Weeks ]
    Decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.


Other Outcome Measures:
  1. biomarkers in serum and plasma [ Time Frame: 12 Weeks ]
    hsCRP

  2. Plasma pharmacokinetics [ Time Frame: 12 Weeks ]
    Plasma concentrations in ng/ml

  3. Adverse effects [ Time Frame: 12 Weeks ]
    Incidence and frequency of treatment-emergent adverse events


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951296


Contacts
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Contact: Clinical Operations +44 (0)207 444 0066 ist07@istesso.co.uk
Contact: General Information +44 (0)207 444 0066 info@istesso.co.uk

Locations
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Sponsors and Collaborators
Modern Biosciences Ltd
More Information
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Responsible Party: Modern Biosciences Ltd
ClinicalTrials.gov Identifier: NCT05951296    
Other Study ID Numbers: IST-07
2023-504418-30 ( EudraCT Number )
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Modern Biosciences Ltd:
IPF
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases