Table 2 Clinical trials of targeted lipid-mediated pathways for pulmonary fibrosis
NCT | Target Specificity | Interventions | Phase | Primary outcome Measures | Enrollment | Allocation | Ref |
|---|---|---|---|---|---|---|---|
01462006 | mTOR inhibitor | Drug: Sirolimus Other: Placebo | 1 | Change in peripheral blood concentration of the CXCR4 + fibrocytes up to 22 weeks Number of subjects with drug side-effects up to 22 weeks | 32 | Randomized Crossover Assignment Quadruple Primary Purpose: Treatment | [140] |
01725139 | PI3K/mTOR inhibitor | Drug: Omipalisib Other: Placebo | 1 | PD endpoints pAKT/AKT AUC in blood for GSK2126458 Cmax in blood for GSK2126458 Pre-dose concentration at the end of the dosing interval in blood for GSK2126458 Concentration of GSK2126458 in BALF | 17 | Randomized Parallel Assignment Double Primary Purpose: Treatment | [141] |
03502902 | PI3K/mTOR inhibitor | Drug: HEC68498 Other: Placebo | 1 | Adverse event up to 4Â weeks: to assess the safety and tolerability of single dose administered | 55 | Randomized Parallel Assignment Quadruple Primary Purpose: Treatment | - |
01766817 | LPA1 receptor antagonist | Drug: BMS-986020 Other: Placebo matching with BMS-986020 | 2 | Change from baseline in FVC rate to week 26 | 325 | Randomized Parallel Assignment Triple Primary Purpose: Treatment | [142] |
04308681 | LPA1 receptor antagonist | Drug: BMS-986278 Other: BMS-986278 placebo | 2 | Rate of change in ppFVC in IPF participants up to week 26 | 278 | Randomized Parallel Assignment Triple Primary Purpose: Treatment | [143] |
04069143 | LPA1 ligand for PET | Diagnostic test: 18F-BMS-986327 | 1 | Incidence of AEs up to 3d after participation Incidence of SAEs up to 30d after participation Radiation dosimetry calculated from PET-CT images 30d after participation Test–retest repeatability 30d after participation Biodistribution and lung uptake calculated from the PET-CT images 30d after participation | 14 | Non-Randomized Parallel Assignment Open Label Primary Purpose: Diagnostic | - |
03711162 | ATX inhibitor | Drug: GLPG1690 (ISABELA1) Other: Placebo | 3 | Annual rate of decline in FVC up to week 52 | 525 | Randomized Parallel Assignment Quadruple Primary Purpose: Treatment | [144] |
03733444 | ATX inhibitor | Drug: GLPG1690 (ISABELA2) Other: Placebo | 3 | Annual rate of decline in FVC up to week 52 | 781 | Randomized Parallel Assignment Quadruple Primary Purpose: Treatment | [144] |
05483907 | ATX inhibitor | Drug: BBT-877 Other: Placebo | 2 | Reduction in FVC (ml) decline compared to the placebo after 24Â weeks of treatment | 120 | Randomized Parallel Assignment Triple Primary Purpose: Treatment | - |
05373914 | ATX inhibitor | Drug: BLD-0409 Other: Matching placebo | 2 | Changes in FVC (L) from Baseline to week 26 | 200 | Randomized Parallel Assignment Quadruple Primary Purpose: Treatment | - |
02538536 | GPR40 agonist/GPR84 antagonist | Drug: PBI-4050 | 2 | Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment (time Frame: 4Â months) | 41 | N/A Single group Assignment Open Label Primary Purpose: Treatment | [145] |
03725852 | GPR84 antagonist | Drug: GLPG1205 Other: Placebo | 2 | Change from baseline in FVC at week 26 | 68 | Randomized Parallel Assignment Quadruple Primary Purpose: Treatment | [146] |