Effect of Statins on Crohn's Disease

NCT06538649 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 76686
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is:

• Can statins reduce the formation of strictures in participants with stricturing Crohn's disease? Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will:
• Take statins or a placebo every day for 6-12 months
• Visit the clinic for lab tests twice after starting either statins or placebo
• Complete questionnaires about symptoms and medications
• Respond to monthly check-ins (via phone call) during participation

Conditions

Crohn's Ileocolitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Rutgeerts score

  Will be assessed at post surgery surveillance colonoscopy. Minimum score is i0 (no lesions) and maximum score is i4 (diffuse inflammation with already larger ulcers, nodules and/or narrowing), with higher scores meaning a worse outcome.

  6-12 months post surgery

Study Arms (2)

Statin

EXPERIMENTAL

Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.

Drug: Rosuvastatin

Control

PLACEBO COMPARATOR

Placebo tablet(s) taken once daily for 6-12 months.

Other: Placebo

Interventions

Rosuvastatin DRUG

Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.

Also known as: Crestor

Statin

Placebo OTHER

Placebo tablet(s)

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of stricturing Crohn's disease
• Scheduled for surgical resection of terminal ileum strictures at either
• Stanford University, or
• Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles

You may not qualify if:

• Pregnant, nursing, or planning to become pregnant in the next 6-12 months
• Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
• Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
• Current use of cyclosporine
• Current use of statin therapy prior to study initiation
• Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
• Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:
• Antifungals (e.g., ketoconazole, itraconazole, voriconazole)
• Fibrate drugs
• Macrolide antibiotics (e.g., erythromycin, clarithromycin)
• Protease inhibitors (e.g., ritonavir, lopinavir)
• Calcium channel blockers (e.g., verapamil, diltiazem)
• Amiodarone
• Warfarin
• Colchicine

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sidhartha R Sinha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touran Fardeen

CONTACT

650-736-5555; tfardeen@stanford.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Random assignment (2:1) to either statin (Arm 1) or placebo (Arm 2), such that 2/3 of participants will be assigned to Arm 1, and 1/3 of participants will be assigned to Arm 2.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)