A Study to Investigate Leramistat in Patients With IPF

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Modern Biosciences Ltd

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.