Tocilizumab for Painful Chronic Pancreatitis
Active, not recruitingPhase 2NCT06426160
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.
Study details
- Official title
- Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial)
- Conditions
- Pancreatitis, Chronic
- Interventions
- Drug: Tocilizumab 20 MG/ML [Actemra]
- Drug: Sodium Chloride 0.9% Inj
- Sponsor
- Soren Schou Olesen
- Collaborators
- Aarhus University Hospital; University of Aarhus; Viborg Regional Hospital; Stanford University; Haukeland University Hospital
- Organization
- Aalborg University Hospital
- Start date
- 2024-05-21
- Primary completion
- 2026-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Signed informed consent. * Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria: * A definitive diagnosis of CP is established by one or more of the following additional criteria: * i) Pancreatic calcification * ii) Moderate or marked ductal lesions (according to the Cambridge classification) * iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation * iv) Histological verification of CP * A probable diagnosis of CP is established by one or more of the following additional criteria: * i) Mild ductal alterations (according to the Cambridge classification) * ii) Recurrent or persistent pseudocysts * iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test) * iv) Diabetes mellitus * Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back). * Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria: * i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level. * ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection. * iii) Signs of pancreatic inflammation on cross-sectional imaging. * ≥ 18 years of age * The participant must be able to read and understand the informed consent forms. * The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures. Exclusion Criteria: * End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume \<20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI). * Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate. * Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational al…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06426160