Pirfenidone as Treatment of Chronic Pancreatitis

NCT07755813 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202506378
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).

Conditions

Chronic Pancreatitis

Keywords

Chronic Pancreatitis; Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least One Grade 3 or Grade 4 Adverse Event as Assessed by CTCAE Version 5.0

  Adverse events will be assessed and graded using a modified Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades events from Grade 1, mild, to Grade 5, death related to adverse event. A participant is counted once if one or more adverse events of Grade 3 or Grade 4 are recorded during the treatment period, regardless of how many such events occur. The proportion of participants meeting this criterion will be compared between the pirfenidone and placebo arms.

  From first dose of study drug through Week 48

Secondary Outcomes (11)

• Rate of Pancreatitis-Related Emergency Room Visits Not Requiring Hospital Admission Per Participant-Year

  From randomization through Week 96

• Rate of Pancreatitis-Related Hospital Admissions Per Participant-Year

  From randomization through Week 96

• Number of Participants With at Least One Documented Episode of Acute Pancreatitis

  From randomization through Week 96

• Mean Change From Baseline in PROMIS Global Health Global Physical Health T-Score

  Baseline (Week 0), Week 48, and Week 96

• Mean Change From Baseline in PROMIS Global Health Global Mental Health T-Score

  Baseline (Week 0), Week 48, and Week 96

Study Arms (2)

Pirfenidone

EXPERIMENTAL

Participants receive pirfenidone 267 mg oral tablets, taken with food three times daily. The dose is titrated over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Drug: Pirfenidone 267 mg Oral Tablet; Other: PROMIS-Global Health; Other: Comprehensive Pain Assessment Tool; Other: Brief Pain Inventory; Other: Pancreatitis Quality of Life Instrument

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo oral tablets, taken with food three times daily. The number of tablets follows the same schedule as the pirfenidone arm over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Drug: Placebo; Other: PROMIS-Global Health; Other: Comprehensive Pain Assessment Tool; Other: Brief Pain Inventory; Other: Pancreatitis Quality of Life Instrument

Interventions

Pirfenidone 267 mg Oral Tablet DRUG

Oral tablets taken with food three times daily. Titrated over 14 days: one tablet three times daily in week 1, two tablets three times daily in week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Continued for 48 weeks unless reduced or interrupted to manage an adverse event. Dispensed by Investigational Drug Services according to the randomization code.

Pirfenidone

Placebo DRUG

Matching placebo tablets, identical in appearance and packaging to the pirfenidone tablets to maintain double blinding. Administered on the same schedule: one tablet three times daily in week 1, two in week 2, and three from week 3 onward, taken with food, for a total of 48 weeks. Dispensed by Investigational Drug Services according to the randomization code.

Placebo

PROMIS-Global Health OTHER

Patient-reported outcome instrument administered to all participants in both arms to assess health-related quality of life. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

Also known as: PROMIS-GH

Pirfenidone; Placebo

Comprehensive Pain Assessment Tool OTHER

Patient-reported outcome instrument administered to all participants in both arms to assess perceived pain. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

Also known as: COMPAT-SF

Pirfenidone; Placebo

Brief Pain Inventory OTHER

Patient-reported outcome instrument administered to all participants in both arms. Administered once per visit and used for two purposes: the pain severity items assess perceived pain, and the pain interference items assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

Also known as: BPI

Pirfenidone; Placebo

Pancreatitis Quality of Life Instrument OTHER

Patient-reported outcome instrument administered to all participants in both arms to assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

Also known as: PANQOLI

Pirfenidone; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 - 85 years of age
• Diagnosis of CP, based on at least one of the following on CT and/or MRI/MRCP:
• Pancreatic parenchymal and/or ductal calcification
• Unequivocal CP on imaging (Tirkes et al3) (Cambridge grade 3 or grade 4)
• Average pain of \>/=4 (on a 0-10 scale) related to pancreatitis in the past three months \[regardless of the use of pain medications (opioids or non-opioids)\] and/or evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months \[inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following: 1) plasma amylase/lipase levels elevated 2-folds or more than the upper limit of normal; 2) elevated plasma levels of CRP 2-fold or more than the upper normal level without suspicion of other sources such as infection; 3) signs of pancreatic inflammation on cross-sectional imaging\]
• Ability to understand and the willingness to sign a written informed consent document and medical release
• Willing and able to comply with trial protocol and follow up

You may not qualify if:

• Age \< 18 or \> 85 years
• Pancreatic endotherapy and/or pancreatic surgery and/or celiac plexus block or neurolysis in last 3 months.
• Known hypersensitivity to Pirfenidone
• AST and/or ALT \> times the upper normal limit
• Bilirubin higher than 1.5 times the upper normal limit
• Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
• On home oxygen or mechanical ventilation
• Clinically diagnosed cirrhosis
• Significant nausea and/or vomiting preventing administration of light diet
• Chronic diarrhea (\>6 months, 3 or more stools/day, which in investigator's opinion is not due to pancreatic exocrine insufficiency)
• Active hepatitis C
• Known history of hepatitis B
• Ongoing photosensitivity and rash
• Known live vaccines or therapeutic infectious agents within one month of potential enrollment
• Known pregnancy or lactation at the time of enrollment

Sponsors & Collaborators

• Vikas Dudeja: lead
• United States Department of Defense: collaborator

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Interventions

pirfenidone; Tablets

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vikas Dudeja, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikas Dudeja, MD

CONTACT

319-353-7474; vikas-dudeja@uiowa.edu

Rimas Nemickas

CONTACT

319-353-8863; rimas-nemickas@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind, placebo-controlled clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Departmental Executive Officer

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year following the primary completion date.