Idiopathic Pulmonary Fibrosis
Conditions
Keywords
IPF, Lung Fibrosis
Brief summary
The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF)
Detailed description
This is a phase 2, randomized, double-blinded, placebo-controlled, efficacy and safety study of cudetaxestat (BLD-0409) assessed across three dose ranges with or without standard of care (nintedanib or pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). The study will include a screening period, a treatment period, and a follow-up period.
Interventions
DRUGCudetaxestat (BLD-0409)
Cudetaxestat - 250mg tablets (orally)
DRUGControl: Matching Placebo
Placebo - 250mg tablets (orally)
Sponsors
Blade Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for participation in this study, subjects must meet all the following: Age 1. At least 40 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF). Type of Subject and Disease Characteristics 2. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) as defined by ATS/ERS/JRS/ALAT guidelines. 3. IPF diagnosis within the past 7 years, with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or surgical biopsy or other appropriate tissue sample (e.g., cryobiopsy) in the medical history. 4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of ≥10% to \<50% parenchymal fibrosis (reticulation) and \<25% honeycombing, within the whole lung. NOTE: HRCT scans will be assessed locally by the investigator prior to randomization. If a recent HRCT scan (within 3 months prior to Screening) is available, it can be utilized for screening purposes. 5. Observed time to disease progression (FVCpp) value \>45% and \<95% at Screening and Day 1 (prior to randomization). 6. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by hemoglobin (Hb) value ≥25% and ≤90% at Screening (determined locally). If a DLCO is available within 3 months prior to Screening, it can be utilized for screening purposes. NOTE: Both FVC and DLCO testing must be representative of the IPF underlying disease (i.e., have been obtained in absence of an acute respiratory event \[e.g., lung infection, cold\]) or other events that are known to affect pulmonary function test (PFT) results (e.g., broken rib, chest pain, other). Contraception Related Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. Male subjects with partners of childbearing potential must use condom and female subjects of childbearing potential (including those \<1 year postmenopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study, and for 30 days after the last dose of IP (males only during exposure to IP). Women not of childbearing potential are defined as: 1. Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women \< 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; OR 2. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to Screening; OR 3. Have a congenital or acquired condition that prevents childbearing. Informed Consent 8. Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol Other 9. Treatment with approved background IPF therapy such as nintedanib or pirfenidone will be allowed as long as subjects are on a stable dose for at least 12 weeks prior to the first dose of the Investigational product and throughout the treatment period.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed changes in FVC (L) from Baseline to Week 26 | Up to 182 days | Change in Forced Vital Capacity FVC (L) from Baseline to Week 26. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed time to disease progression (FVCpp) decline of ≥10% or death | Up to 182 days | Time to disease progression |
| Observed time to disease progression (FVCpp) decline of ≥5% or death | Up to 182 days | Time to disease progression. |
| Observed changes in Quantitative Lung Fibrosis (QLF) from Baseline to Week 26 | Up to 182 days | Assessed by high-resolution computed tomography (HRCT) |
| Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) | Up to 182 days | Safety and tolerability will be assessed based on the incidence, nature and severity of TEAEs and SAEs, and changes in safety laboratories, vitals and ECGs |
Contacts
Primary ContactChandarani Shinde
Outcome results
None listed