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A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Primary:- To evaluate the safety and tolerability of repeat doses of GSK2831781 during the Induction Phase.- To characterise the efficacy dose-response of GSK2831781 during the Induction Phase.Secondary:- To evaluate the safety and tolerability of…

Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy.

To determine the safety, feasibility, and tolerability of adding PIPAC with oxaliplatin (92 mg/m2) to systemic chemotherapy in patients with isolated PM from CRC.

Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis

The Budesonide oral suspension is a new drug formulation especially developed for the treatment of eosinophile esophagitis in children and adolescents. The purpose of this clinical study is to investigate whether Budesonide oral suspension is…

Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy

see section 21 & 2.2This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-ontherapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activitydespite pre-existing TNFi treatment.…

A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

The primary objective of the study is to compare the efficacy of RPC1063 vs placebo for induction of clinical remission at Week 8 in patients with moderately to severely active ulcerative colitis (UC)The secondary objectives are to:• Compare the…

Fecal Transplantation in adolescents with refractory Irritable Bowel Syndrome

In this study we would like to investigate whether fecal transplantation, administered through a nasoduodenal tube, from either allogenic or autologous donors, has beneficial efffects on IBS symptoms such as abdominal pain intensity and frequency,…

A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn*s disease

The primary objective is to evaluate the efficacy of V565 555 mg TID in subjects with active CD measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI)…

Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Ulcerative Colitis (UC). Subjects who are biologic-naïve and…

Neoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in non-metastatic, resectable gastric and GE-junction cancer. ;The PANDA trial

This study has been transitioned to CTIS with ID 2024-519075-26-00 check the CTIS register for the current data. Primary objective: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-…

CROSSFIRE trial: Crossatlantic Randomized controlled trial comparing Outcome in Survival after Systemic plus Focal therapy for Inoperable pancreatic carcinoma: Radiotherapy versus irreversible Electroporation

The objective of this study is to compare the efficacy of chemotherapy and IRE (experimental arm) to the efficacy of chemotherapy and radiation (control arm) in patients with locally advanced, non-resectable, non-metastasized, pancreatic cancer.

Intra-arterial Lutetium-177- dotatate for treatment of patients with neuroendocrine tumor liver metastases

To investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objective is to to evaluate if there is a difference in post-treatment tumor-to-non-…

Imaging tumor angiogenesis using [18F]-DCFPyL PET/CT in patients with colon, gastric and pancreatic cancer.

Assess the feasibility of [18F]-DCFPyL PET/CT imaging to detect primary colon, gastric and pancreatic cancer.

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

The purpose of this study is to see how filgotinib, the experimental drug, affects male sperm and to see if it is a safe and effective treatment for men with moderately to severely active inlammatory bowel disease.

Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited MEtastatic PANcreatic Cancer (MEPANC-1)

This study has been transitioned to CTIS with ID 2024-514598-23-00 check the CTIS register for the current data. This is an open-label, non-randomized, multicentre phase II study with an initial safety-run in. During the safety run-in phase, we will…

Preoperative radiotherapy in patients at very high risk of postoperative pancreatic fistula after pancreatoduodenectomy (FIBROPANC-1): a multicenter phase II study

To investigate the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk of developing postoperative pancreatic fistula (>25%).

Study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus - part 2

The aim of the current study is to assess the feasibility, safety and efficacy of the Steam ablation System for eradication of short segment BE.

RIC-NEC Phase II Feasibility Randomized Controlled Trial: Remote Ischemic Conditioning in Necrotizing Enterocolitis

Primary Endpoint: Feasibility of including patients in the study, randomization and delivery of the intervention. To assess the primary endpoint, we will examine the probability that: (1) a screened patient is eligible; (2) an eligible patient…

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

This study has been transitioned to CTIS with ID 2024-518627-29-00 check the CTIS register for the current data. PRIMARY OBJECTIVE• To compare the efficacy of Ampligen® versus control group / no treatment following FOLFIRINOX in subjects with…

A Phase II, multicentre, double-blind, randomised, placebo-controlled study
of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn*s disease recurrence
(STOP-Postoperative Endoscopic Recurrence Study)

Primary objective:To demonstrate the efficacy of Rifaximin -EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn*s disease recurrence following ileocolonic resection

A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY,
PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY,
AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED
WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

This study will evaluate the safety, efficacy, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis (UC).