RecruitingPhase 2NCT06426160

Tocilizumab for Painful Chronic Pancreatitis

Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial)

Sponsor

Soren Schou Olesen

Enrollment

36 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatitis, Chronic

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria20

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 Criteria12

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 alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed.
Active or recurrent infections.
Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded).
Known hypersensitivity to Tocilizumab.
Positive test for Tuberculosis during screening
Positive test for Hepatitis during screening
Severe liver disease, indicated by ALT with >5 upper normal limits.
Thrombocytopenia (platelet count < 50 x 109/L).
Neutropenia (neutrophil count <2 x 109/L).
Pregnancy and no contraception use, fertile women (<55 years) must provide a urine sample for pregnancy test upon inclusion.