Inflammatory Bowel Disease Clinical Trials

Patients coming to Cedars-Sinai for help with inflammatory bowel disease have easily accessible opportunities to participate in clinical trials and research. The doctors and scientists at Cedars-Sinai have made many pioneering discoveries in the field, developed new therapies for disease management and are consulted by doctors around the world for their expertise in quickly bringing diagnostic and treatment advances out of the lab and into patient care plans.

Questions? See the Clinical Trials FAQs.

Condition:

Inflammatory bowel disease

Participant Requirements:

  • Diagnosis of IBD
  • Family members of patients participating in the M.I.R.I.A.D. Biobank
  • Control subjects without IBD

Summary:

The purpose of the M.I.R.I.A.D. Biobank is to advance the understanding of inflammatory bowel diseases (IBD) and other inflammatory disorders. The Biobank collects specimens for immediate use in research studies and maintains specimens for future use. It also gathers information about donated samples from participants’ medical records. Specimens and health information are used in M.I.R.I.A.D. Biobank-supported investigations to improve the diagnosis and treatment of disease. Current and future uses of specimens may include genome sequencing, stem cell research and/or creation of cell lines.

Please see additional information regarding this study.

Condition:

Inflammatory bowel disease

Participant Requirements:

  • At least 18 years old
  • Diagnosis of Crohn’s disease, ulcerative colitis or IBD undetermined
  • Accept conditions of informed consent
  • Affiliated with a participating IBD care site

Summary:

This study is designed as a program to collect health information from adults with inflammatory bowel disease (IBD) to better understand the disease and improve the quality of care for individuals living with IBD. The program will focus on a new way to manage IBD care, referred to as a dashboard, which will allow for more informed and productive communication between patients and providers.

Health information will be collected for quality improvement initiatives and research from three sources: medical records at the IBD Care Center, information that the provider enters into the dashboard, and information that the patient enters into the dashboard. Data will be maintained in a secure database

Condition:

Ulcerative colitis, Crohn's disease

Participant Requirements:

  • Weighs ≥10 kg
  • 2-17 years old, with moderately to severely active UC or CD diagnosed at least 3 months before screening

Summary:

This study focuses on children diagnosed with either Crohn’s disease (CD) or ulcerative colitis (UC) and who are between the ages of 2 and 17. The purpose of the study is to examine how a drug called vedolizumab is processed by the body in these children. Researchers also aim to evaluate whether vedolizumab is safe and effective for the treatment of UC and CD in children and to determine which dose may be best. Vedolizumab belongs to a group of proteins called antibodies, which help to reduce inflammation that can cause the symptoms in CD and UC. The use of vedolizumab in this study is investigational.

Condition:

Ulcerative colitis, Crohn's disease

Participant Requirements:

  • Male or female with UC or CD between 2-17 years old at the time of group assignment for study MLN0002-2003
  • Completed study MLN0002-2003 and at week 22 of the study, achieved clinical response

Summary:

This study focuses on patients who have previously participated in the MLN0002-2003 study (A Phase II, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease). Researchers will evaluate the long-term safety of a drug called vedolizumab in children who have ulcerative colitis (UC) or Crohn's disease (CD).

Condition:

Crohn's disease

Participant Requirements:

  • Be 18-80 years old (Where locally permissible, individuals who are 16 to <18 years old and who meet specific criteria are eligible.)
  • Have confirmed diagnosis of Crohn's disease for at least 3 months prior to baseline visit
  • Have Crohn's disease activity index score 220–450 at baseline

Summary:

This study focuses on individuals diagnosed with Crohn's disease and who are experiencing symptoms such as diarrhea, abdominal pain and/or a sudden and constant urge to move their bowels. The purpose of the study is to evaluate the efficacy and safety of various doses of an investigational drug called risankizumab and to determine how well it works in patients with moderate to severe Crohn's disease.

Condition:

Crohn's disease

Participant Requirements:

  • At least 18 years old
  • Documented diagnosis of Crohn’s disease (CD) confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
  • Planning to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before assignment to study group

Summary:

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called TAK-018 in patients with Crohn’s disease after bowel resection. The study will also evaluate whether TAK-018 can prevent CD from recurring after surgery. TAK-018 works by blocking a type of gut bacteria that enters the bowel wall.

Condition:

Crohn’s disease

Participant Requirements:

  • 18-60 years old
  • Diagnosis of Crohn’s disease with minimum disease duration of 6 months with involvement of the ileum and/or colon, documented on colonoscopy
  • Endoscopically confirmed, active Crohn’s disease

Summary:

This study focuses on individuals who have been diagnosed with Crohn’s disease and are at risk for fungal infection based on genetic determination. The purpose of the study is to evaluate the effects of oral posaconazole for the treatment of active Crohn’s disease in a genetically defined population.

Condition:

Inflammatory bowel disease, COVID-19

Participant Requirements:

  • Participants for whom vaccines are authorized for ages 13 and over with inflammatory bowel disease (IBD)
  • History of chronic (more than 1 month) ulcerative colitis or Crohn’s disease
  • Planned or prior receipt of any authorized vaccine against COVID-19

Summary:

This study focuses on individuals who are at least 13 years old and have inflammatory bowel disease (Crohn’s disease or ulcerative colitis). The purpose of the study is to understand the effects of COVID-19 vaccination in these patients.