Clinical trialNCT05660746RecruitingPhase 2/PHASE3Interventional

Precise Infliximab Exposure and Pharmacodynamic Control

SponsorChildren's Hospital Medical Center, CincinnatiEnrollment180Crohn Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Phillip Minar, MD,MS
Children's Hospital Medical Center, Cincinnati
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital of Los Angeles
Los Angeles, California, United States
Mallory Chavannes, MD
Recruiting
Lucile Packard Children'S Hospital Stanford
Palo Alto, California, United States
Alka Goyal, MD
Recruiting
Rady Children'S Hospital San Diego
San Diego, California, United States
Laura Bauman, MD
Recruiting
Nemours Children'S Health System-Wilmington
Wilmington, Delaware, United States
Zarela Molle-Rios, MD
Recruiting
Nemours Children'S Health System-Jacksonville
Jacksonville, Florida, United States
Jill Dorsey, MD
Recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Steven Steiner, MD
Recruiting
Cincinnati Children'S Hospital
Cincinnati, Ohio, United States
Phillip Minar, MD, MS
Recruiting
Cleveland Clinic Children'S Hospital
Cleveland, Ohio, United States
Jacob Kurowski, MD
Recruiting
Nationwide Children'S Hospital
Columbus, Ohio, United States
Brendan Boyle
Recruiting
Children'S Specialty Group
Norfolk, Virginia, United States
Rana Ammoury, MD
Recruiting
Medical College of Wisconsin, Children'S of Wisconsin
Milwaukee, Wisconsin, United States
Joshua Noe, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Infliximab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jul 2023
Primary completion: 31 Mar 2027
Completion: 31 Mar 2027
Last update posted: 5 May 2026
Registered enrollment: 180
Registry id: NCT05660746

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.