23 results
The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…
Primary Objectives: - To test the feasibility of culturing patient-derived Barrett*s esophagus organoids- To test pharmacological and chemotherapeutical agents in vitro on the cultured organoidsSecondary Objectives: - To create a small Biobank (of…
Primary Objective:* To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CDSecondary Objectives:* To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to…
The evaluation of the safety and feasibilty of the Photopill capsule treatment in patients with Ulcerative Proctitis
Primary objective: to study the effect of faecal transplantation in a phase II randomised placebo controlled design on simple clinical colitis activity index (SCCAI) and endoscopic Mayo score. Secondary objective: to study intra individual changes…
1.1 Safety To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn*s disease 1.2 Efficacy * To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and the Crohn*s Disease Activity Index (CDAI)* To…
Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…
The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…
The primary objective will be to evaluate the safety and tolerability of LYC-30937-EC in subjects with UC.An exploratory objective will be to assess symptoms of UC for up to 44 weeks.
1. To evaluate the long-term safety of spesolimab in patients with fistulising Crohn*s disease who have completed treatment in previous trials.2. To evaluate the long-term efficacy of spesolimab in patients with fistulising Crohn*s disease who have…
To assess efficacy and safety of tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis.
To evaluate the efficacy of tofacitinib treatment in patients with RCDII with persistent or recurrent villous atrophy (Marsh III ABC) and aberrant IEL T-cells (> 20% as assessed by flow cytometry).
Study IM011-077 is a Phase 2 randomized, open-label, multicenter clinical study designed to assess the safety and tolerability, efficacy and biomarker response of deucravacitinib 6 mg BID (twice daily) in subjects with moderate to severe Ulcerative…
To study the effectiveness and safety of administration of FMT on acute pouchitis.
Protocol section 2.1:* Demonstration of the long term safety of BI655130 in patients with moderate to severe active colitis Ulcerosa who have already been treated in previous studies.* Demonstration of the long term efficacy of BI655130 in patients…
To assess the safety of endoscopic injected allogeneic bone marrow derived mesenchymal stromal cells (BMMSCs) in refractory proctitis.
Primary Objective: • To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.Secondary Objectives:• To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel…
This study has been transitioned to CTIS with ID 2024-510727-19-00 check the CTIS register for the current data. The primary objective of this study is to observe the long-term efficacy, safety, and tolerability of repeated administration of…
The main objective of Study M15-722 is to characterize the efficacy, safety, and tolerability of ravagalimab (ABBV-323) as induction treatment in subjects with moderately to severely active UC.
That patients who have had clinical response or clinical remission after use with Risankizumab can continue using Risankizumab. Also long term safety of Risankizumab will be assessed in patients who were diagnosed with moderate to severe Crohn'…