8 results
All primary and secondary objectives will compare zanubrutinib (also known as BGB-3111) plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation only.Primary:• To compare efficacy, as measured by…
The purpose of this study is to evaluate whether the new drug reldesemtiv is effective and safe in patients with ALS. The primary objective is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.The secondary objectives…
Primary objectivePrimary population (former smokers cohort):- Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD.Secondary…
Primary objectives: Part A: Generate an airway gene expression signature for itepekimab treatment using RNA sequencing in former smokers with COPDPart B: Validate the airway gene expression signature from Part A in former smokers with COPD in Part…
Primary:• Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA.• Part B: To evaluate the efficacy of the selected dose in adults with wAIHA.Secondary:• Part A (Cohorts 2 and 3 only)-To…
The aim of the follow-up study is to determine the differences between early versus late treatment with GZ / SAR402671 in the effect on total kidney volume growth (total kidney volume, TKV) and in the effect on slowing down renal impairment (change…
Comparing the selected active drug dose to placebo by utilizing the primary endpoint *ventilator-free survival* at Study Day 28 (i.e. 28 days after treatment initiation). This primary efficacy endpoint is evaluating the proportion of participants…
1.1 Primary study objectives To investigate the safety, tolerability and biochemical effects of 225Ac-PSMA injected in patients with metastatic prostate cancer. Primary objective:- To assess the safety and tolerability of 225Ac-PSMA administered…