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New drug shows promise for speeding recovery in severe pancreatitis

NCT ID NCT04681066

Disease control Sponsor: CalciMedica, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tested a drug called Auxora in 216 people hospitalized with acute pancreatitis and systemic inflammatory response syndrome (SIRS), a serious body-wide inflammation. Participants received either Auxora or a placebo daily for three days. The main goal was to see if Auxora helped patients tolerate solid food sooner, a key sign of recovery. The trial is complete, and results will help determine if Auxora is effective for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

216 people

The number who actually took part.

Started

Mar 2021

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All of the following must be met for a patient to be randomized into the study: 1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria: 1. Serum lipase \> 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pancreatitis on abdominal imaging; 2. The diagnosis of SIRS has been established by the presence of at least two of the following four criteria: 1. Temperature \< 36°C or \> 38°C; 2. Heart rate \> 90 beats/minute; 3. Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg; 4. White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms; 3. At least one of the following criteria is also present: 1. A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization; 2. Abdominal examination documenting either abdominal guarding or rebound tenderness; 3. Hematocrit ≥44% for men or ≥40% for women; 4. The patient is ≥ 18 years of age; 5. Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization; 6. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days; 7. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days; 8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. Exclusion Criteria: Patients with any of the following conditions or characteristics must be excluded from randomizing: 1. Expected survival \<6 months; 2. Suspected presence of cholangitis in the judgment of the treating physician; 3. The patient has a known history of: 1. Organ or hematologic transplant; 2. HIV, hepatitis B, or hepatitis C infection; 3. Chronic pancreatitis; 4. Current treatment with: 1. Chemotherapy; 2. Immunosuppressive medications or immunotherapy 3. Pancreatic enzyme replacement therapy; 4. Hemodialysis or Peritoneal Dialysis; 5. The patient is known to be pregnant or is nursing; 6. The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization; 7. Allergy to eggs or known hypersensitivity to any components of study drug.

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Conditions

The condition(s) this trial relates to.

acute pancreatitis pancreatitis Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pancreatitis Systemic inflammatory response syndrome

Contacts and locations

Locations

  • CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304, United States

  • Cedars Sinai

    Los Angeles, California, 90048, United States

  • Harbor UCLA Medical Center

    Torrance, California, 90502, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • IGMU (India Gandhi Medical)

    Shimla, India

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • JIPMER

    Puducherry, India

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104, United States

  • LA County Hospital - USC

    Los Angeles, California, 90033, United States

  • Lisie Hospital

    Kochi, India

  • Long Beach Medical Center

    Long Beach, California, 90806, United States

  • MDM Hospital

    Jodhpur, India

  • MTES' Sanjeevan Hospital

    Pune, India

  • Malla Reddy Narayana

    Hyderabad, India

  • Methodist Hospital

    Saint Louis Park, Minnesota, 55426, United States

  • Northshore University Hospital

    Manhasset, New York, 11030, United States

  • Northwestern University Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43201, United States

  • PGIMER, Chandigarh

    Chandigarh, India

  • Regional One Health

    Memphis, Tennessee, 38106, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206, United States

  • SPMC

    Bīkaner, India

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239, United States

  • Seven Star Hospital

    Nagpur, India

  • Shree Giriraj Multispeciality Hospital

    Rajkot, India

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Stamford Hospital

    Stamford, Connecticut, 06902, United States

  • Torrance Memorial Medical Center

    Torrance, California, 90505, United States

  • UT Health Houston

    Houston, Texas, 77030, United States

  • University of California at Irvine Medical Center

    Orange, California, 92868, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Missouri School of Medicine

    Columbia, Missouri, 65212, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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