8 results
Primary objective: To investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
Primary Objectives:* To evaluate the effects of therapeutic and supratherapeutic plasma levels of arimoclomol on the heart rate-corrected QT interval (QTc).Secondary Objectives:* To evaluate the effect of arimoclomol on other ECG parameters: heart…
Primary objectiveTo determine the efficacy of chronic treatment with arimoclomol 1200 mg/day (400 mg TID) compared to placebo over 76 weeks in subjects with ALS as assessed with Combined Assessment of Function and Survival (CAFS).Secondary…
Primary objective:To assess the long-term safety of arimoclomol treatment of ALS.Secondary objective:To evaluate the long-term efficacy of arimoclomol treatment of ALS.Exploratory objectives:Health-related quality of life* To evaluate the effect of…
Primary Objectives:- Phase II: To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)- Phase III: To demonstrate the efficacy of IFX-1 to improve of symptoms and outcome of severe COVID-19 pneumonia (confirmative…
The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…
*In the phase Ib study: to assess the feasibility and safety of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.*In the phase II study: to assess the impact of the addition of the addition of nivolumab…