7 results
DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A.
Primary objectives:To assess the proportion of non-severe hemophilia A patients within FVIII target levels with the DDAVP and FVIII concentrate combination treatment in the first 72 hours after the start of combination treatment, without adding off-…
Protocol section 2.1 and 2.2
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
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…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…
Primary Objectives:• Determine the safety and tolerability of CC-122 administered in combination with obinutuzumab.• Determine the non-tolerated dose (NTD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of CC-122 administered in…