8 results
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
Primary objectiveThe primary objective is to evaluate the effect of Pirfenidone on the change in FEV1 over 6 months in lung transplant recipients with BOS, who are treated with Azithromycin.Secondary objectives The secondary objectives involve the…
to investigate the safety and tolerability of pirfenidone in asbestosis patients
1. To evaluate the long-term safety of spesolimab in patients with fistulising Crohn*s disease who have completed treatment in previous trials.2. To evaluate the long-term efficacy of spesolimab in patients with fistulising Crohn*s disease who have…
The primary objectives of this trial are:- To explore the pathomechanisms involved in the generation and healing of CD associated perianal fistulas- To understand the MoA of BI 655130 in patients with CD and draining perianal fistulas