12 results
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…
In the present study the effects of the colonic administration of butyrate on portal, hepatic, mesenteric venous and arterial SCFA concentrations will be studied in patients undergoing major upper abdominal surgery. The aim is to clarify the…
JNJ-2607019 is an investigational drug being developed for gastroesophageal reflux disease (GERD) to reduce the complaints of abdominal pain and heartburn in people with this disease. JNJ-26070109 inhibits the gastrin receptor in the stomach. The…
Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…
The aim of the Mint study is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules in reducing abdominal pain intensity in these children. In addition, we investigate the effect of peppermint oil capsules compared…
The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in
Subjects with Ulcerative Colitis
The primary objective of this study is:* To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in UCThe…
The primary objective of this study is:- To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CDThe secondary objective of…
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).
To determine the optimal dose of IMU-838 to induce symptomatic remission and endoscopic healing in patients with moderate-to-severe ulcerative colitis (UC)
This study has been transitioned to CTIS with ID 2023-506046-24-00 check the CTIS register for the current data. Main:To evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC)…