Tocilizumab for Painful Chronic Pancreatitis

NCT06426160 | Recruiting Phase 2 DMC

• 2 other identifiers: F2024-0542023-510084-35-00
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatitis, Chronic

Keywords

Inflammation; Pancreatic diseases; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire

  The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain.

  The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization)

Secondary Outcomes (17)

• Global Quality of Life Score (EORTC-QLQ-C30)

  The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)

• Physical Functional Score (EORTC-QLQ-C30)

  The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)

• Role Functional Score (EORTC-QLQ-C30)

  The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)

• Cognitive Functional Score (EORTC-QLQ-C30)

  The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)

• Emotional Functional Score (EORTC-QLQ-C30)

  The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)

Other Outcomes (16)

• Levels of soluble inflammation biomarker

  The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)

• Levels of soluble fibrosis biomarker

  The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)

• Levels of soluble Biomarker of Macrophage Activation

  The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)

Study Arms (2)

Tocilizumab

ACTIVE COMPARATOR

8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %)

Drug: Tocilizumab 20 MG/ML [Actemra]

Placebo

PLACEBO COMPARATOR

100 ml sodium chloride 9 mg/mL (0.9 %).

Drug: Sodium Chloride 0.9% Inj

Interventions

Tocilizumab 20 MG/ML [Actemra] DRUG

Tocilizumab 8 mg/kg every four weeks for 24 weeks.

Also known as: RoActemra, Actemra

Tocilizumab

Sodium Chloride 0.9% Inj DRUG

Placebo (Sodium chloride) every four weeks for 24 weeks.

Also known as: Natriumchloride 0.9 % Inj

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Soren Schou Olesen: lead
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator
• Viborg Regional Hospital: collaborator
• Stanford University: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Inflammation; Pancreatic Diseases; Digestive System Diseases

Interventions

tocilizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Søren S Olesen, MD, Ph.D.

  Mech-Sense, Department of Gastroenterology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasmus Hagn-Meincke, MD

CONTACT

004597663520; r.hagnmeincke@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Ph.D.

Model Details: Randomised, placebo-controlled, double-blinded investigator-initiated trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 23, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)