Das Studienzentrum der II. Medizinischen Klinik führt klinische Studien der Phase I bis IV durch. Neben zahlreichen Investigator-initiated Trials (IIT) werden klinische Studien aller Phasen in den Bereichen der Gastroenterologie (CED), der gastroenterologischen Onkologie, der Hepatologie, der Infektiologie u.a. durchgeführt. Die Studienärzt*innen und Studienassistentinnen bilden sich regelmäßig fort und sind hinsichtlich der klinischen Studiendurchführung ausgewiesene Experten. Die Klinik ist integraler Bestandteil verschiedener Studiennetzwerke und kooperiert mit den Klinischen Studienzentren in Heidelberg und Freiburg. Innovative Studien bilden ein wesentliches Element der universitären Maximalversorgung.

Leberstudien

BI 1404-0044: A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis (offen), EU CT Number 2024-513739-25-00

BI 1404-0064: A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated non-alcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis (offen),  EU CT Number 2024-513741-36-00

Onkologische Studien

PROMISE: Aus Patienten stammende Organoide zur Modellierung der Tumorbiologie und Vorhersage von Therapieansprechen (offen)

ABC-HCC: A Phase IIIb, randomized, multicenter, open-label trial of Atezolizumab plus Bevacizumab versus transarterial Chemoembolization (TACE) in intermediate-stage Hepatocellular Carcinoma with high disease burden (offen), EU CT Number 2024-512953-26-00

Liver-R: An Observational Multi-center Study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers (offen)

idhira: Ivosidenib in locally advanced or metastatic cholangiocarcinoma with IDH1 R132 mutation after at least one prior systemic treatment - a prospective, multicenter, observational study in Germany (offen)

adIVO: A phase II trial of ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma (offen), EU CT Number 2024-520219-42-00

Astellas 3082-CL-0301: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma (geplant), EU CT Number 2025-523684-38

UNITEPANC: Using organoids to predict efficacy of adjuvant treatment to improve outcome in resectable pancreatic cancer - Interventional, prospective, multisite, proof-of-concept, single-arm trial (offen), EU CT Number 2023-510490-34-00

FLORA: Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial (geplant), EU CT Number 2023-506887-15-00

CED Studien

Clinnova-IBD:  A prospective cohort study of patients with Inflammatory Bowel Disease: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (offen)

Target-CD: A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease (offen), EU CT Number 2024-513009-30

ORNATUS-1: A Phase II/III, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) for induction and maintenance therapy in patients with mild to moderately active ulcerative colitis (offen), EU CT Number 2024-510807-13-00

TAK-279-CD-2001: A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease (offen), EU CT Number 2023-506704-14

VICTRIVA: A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn’s Disease (offen), EU CT Number 2023-509391-42

CHARGE: A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease (geplant), EU CT Number 2025-521590-13

DUET ENCORE-CD: A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease (geplant), EU CT Number 2026-525922-39

DUET ENCORE-UC: A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis (geplant), EU CT Number 2026-525923-26

Re-Introduce: Retreatment with subcutaneous Infliximab in patients with refractory Crohn’s disease - an observational study (offen)

Ernährung

CEC-013/CEL: A phase II, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (offen)

Pankreas

PESPA: A prospective evaluation of scoring systems for chronic pancreatitis (offen)