13 results
The objective of the study is to compare the efficacy and tolerability of mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence of diverticulitis. Additionally, the safety and tolerability in the form of adverse events and…
Primary endpoint:- Successful desensitization for Mesalazine in ulcerative colitis patients with a presumed history of intolerance for Mesalazine. Secondary endpoint:- To investigate if a presumed intolerance for Mesalazine may be reproducible in a…
Primary objectives1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD?2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease…
1) Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on apoptosis and proliferation in histologically normal sigmoid and rectal mucosa…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
Primary: · To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment.Secondary:· Determine the safety of DARA plus DURVA in subjects…
Protocol section 2.1 and 2.2
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 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…
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
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…
The purpose of this study is to compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and lenalidomide (Tec-DR and Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).