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Treatment of acute pancreatitis with infliximab

Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.

PHASE2 · University of Liverpool · NCT03684278

This study is testing if a medication called infliximab can help adults with acute pancreatitis feel better and avoid complications.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment290 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorUniversity of Liverpool (other)
Drugs / interventionsinfliximab, chemotherapy
Locations13 sites (Aberdeen, Aberdeenshire and 12 other locations)
Trial IDNCT03684278 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of infliximab, a monoclonal antibody that blocks tumor necrosis factor alpha (TNFα), in treating acute pancreatitis in adults. Participants will be randomly assigned to receive either a single infusion of infliximab at two different doses or a placebo. The study aims to assess the efficacy of early anti-TNF treatment in reducing inflammation and preventing complications associated with acute pancreatitis. By using a double-blind, placebo-controlled design, the trial seeks to establish new standards for treatment protocols in acute pancreatitis.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with acute pancreatitis within 36 hours of hospital admission.

Not a fit: Patients with chronic pancreatitis or those with certain neurological and cardiac conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from acute pancreatitis by reducing inflammation and preventing organ failure.

How similar studies have performed: While the use of infliximab in acute pancreatitis is a novel approach, previous studies targeting TNFα in inflammatory conditions have shown promise.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients attending Accident and Emergency (A\&E) at or admitted to recruiting hospitals via a GP with a new diagnosis of AP established by two of the following three criteria: (1) typical continuous upper abdominal pain; (2) amylase and/or lipase three or more times the upper limit of normal; (3) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI)
* Patients in whom trial treatment can be started within 36 hours of admission to hospital with a new diagnosis of acute pancreatitis allowing 120 min for preparation of trial medication
* Patients from whom appropriate consent is obtained (from the patient or their legal representative).

Exclusion Criteria:

* Age \<18 or \>85
* Patients with a bodyweight over 200 kg
* Known previous AP within the last 30 days or chronic pancreatitis
* Multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder
* Known epilepsy
* Moderate to severe heart failure and/or coronary disease (NYHA III/IV)
* Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)
* On home oxygen or home mechanical ventilation
* Jaundice and/or known advanced liver disease
* Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6 months
* Known haematological malignancy
* Known cancer with palliative care
* Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset
* Known history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection
* Known history of infective hepatitis
* Rare diseases or inborn errors of metabolism that significantly increase the risk of infections, including severe combined immunodeficiency (SCID) and homozygous sickle cell disease
* Known live vaccine or infectious agent within one month of admission
* Known immunosuppressive or biologic therapy within one month of admission
* Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
* Known pregnancy or lactation at admission
* Females of childbearing potential who do not agree to use adequate contraception up to 6 months after infliximab infusion
* Known participation in investigational medicinal product study within last three months.

Where this trial is running

Aberdeen, Aberdeenshire and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Pancreatitis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.