Fibrosis clinical trials at University of California Health

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

This interventional study will test whether a low cost and largely non-toxic small molecule, purified from green tea, EGCG, is safe when given to IPF patients with mild-moderate disease and without significant interactions with standard of care drugs. The rationale for the study is, first, the extensive prior pre-clinical data in mice that the trihydroxyphenolic EGCG is efficacious in attenuating pulmonary fibrosis by blocking collagen cross-linking and the pro-fibrotic pathway mediated by TGFβ1 signaling. More compelling are recently published data demonstrating that in humans EGCG is safe and capable of blocking lung tissue pro-fibrotic signaling when given two weeks prior to diagnostic surgical biopsy of pulmonary fibrosis patients, many of whom were subsequently diagnosed with IPF. Changes in three blood markers reflecting TGFβ signaling were also consistent with attenuation of signaling by EGCG in vivo in these patients. However, EGCG has never been given for longer than two weeks to IPF patients. The study aims to assess the safety in patients given daily oral EGCG over 12 weeks with the IPF drugs, pirfenidone and nintedanib. Eligible patients will be enrolled in one of four groups: EGCG 400 mg with pirfenidone (n= 10 per group), EGCG 400 mg with nintedanib (n= 10 per group), placebo with Nintedanib (n= 5 per group), placebo with Pirfenidone (n= 5 per group). If no safety concerns, in terms of adverse events or significant drug-drug interactions, are raised after all subjects in a group have completed 12 weeks of treatment and 4 weeks of follow-up, enrollment will begin into the higher dose group. 2 additional groups will be enrolled: EGCG 600 mg with pirfenidone (n= 10 per group), EGCG 600 mg with nintedanib (n= 10 per group). The total duration of trial for each group will be 12 weeks of treatment and 4 weeks of follow-up assuming no study-limiting adverse events or significant drug-drug interactions. Study participants will be followed closely for the development of treatment-related adverse events, especially hepatotoxicity. Participants will also be tested for the impact of EGCG on the expected (peak and trough) blood levels of nintedanib or pirfenidone and vice versa. Each group will have blood drawn on days 1, 14, and 84 to compare pre-determined biomarker changes as a possible determinant of dosing in a future phase II trial.

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.