A Study to Investigate Leramistat in Patients With IPF

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

Tracking Information

• First Submitted Date: June 22, 2023
• First Posted Date: July 19, 2023
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: August 30, 2023
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 10, 2023)

Forced vital capacity (FVC) [ Time Frame: 12 weeks ]

Change from baseline in FVC versus placebo up to Week 12

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2023)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 10, 2023)

• biomarkers in serum and plasma [ Time Frame: 12 Weeks ]
  hsCRP
• Plasma pharmacokinetics [ Time Frame: 12 Weeks ]
  Plasma concentrations in ng/ml
• Adverse effects [ Time Frame: 12 Weeks ]
  Incidence and frequency of treatment-emergent adverse events

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study to Investigate Leramistat in Patients With IPF
• 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)
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: Leramistat
  Drug: Leramistat
• Drug: Placebo
  Placebo comparator

Study Arms

• Experimental: Leramistat
  Leramistat once daily
  Intervention: Drug: Leramistat
• Placebo Comparator: Placebo
  Placebo comparator
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 10, 2023): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Operations; +44 (0)207 444 0066; ist07@istesso.co.uk

Contact: General Information; +44 (0)207 444 0066; info@istesso.co.uk

• Listed Location Countries: France, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05951296
• Other Study ID Numbers: IST-07; 2023-504418-30 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Modern Biosciences Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Modern Biosciences Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Modern Biosciences Ltd
• Verification Date: November 2023