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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:

Crohn's Disease

Participant Requirements:

  • 18-75 years old
  • Documented diagnosis of Crohn’s disease with a minimum disease duration of 6 months, with involvement of the ileum and/or colon at a minimum
  • Moderately or severely active Crohn’s disease

Summary:

This study focuses on individuals diagnosed with Crohn’s disease, an inflammatory disease of the gastrointestinal tract (digestive tract). The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe Crohn’s disease. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

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:

  • Be at least 18 years old
  • Have history of Crohn's disease with involvement of at least the ileum or any portion of the colon at a minimum
  • Have up-to-date colorectal cancer screening, per locally adopted guidelines

Summary:

The purpose of this study is to evaluate the effectiveness of an investigational drug called TD-1473 in individuals with Crohn's disease. Specifically, the study will assess the safety and tolerability of TD-1473, as well as its effect on quality of life. Researchers will measure the way the body absorbs, distributes and gets rid of the study drug (pharmacokinetics), in addition to examining the effects of the drug on the human body (pharmacodynamics).

Condition:

Inflammatory bowel disease

Participant Requirements:

  • Be adults with confirmed inflammatory bowel disease (IBD) diagnosis; admitted for IBD-related complaint

Summary:

This study focuses on patients who were admitted to the hospital for an inflammatory bowel disease (IBD)-related complaint and who may experience pain during hospitalization. The purpose of the study is to determine whether a proactive, IBD-specific, pain medication protocol is better than the reactive approach to managing pain in hospitalized adults with IBD.

Condition:

Crohn's disease

Participant Requirements:

  • Entry and completion of study M16-006, M15-991 or M15-989
  • Achieved clinical response at the last visit of M16-006 or M15-991

Summary:

The purpose of this study is to evaluate the effectiveness and safety of various doses of an investigational drug called risankizumab, and to determine how well it works as maintenance therapy and long-term therapy for patients with moderate to severe Crohn’s disease who have completed participation in the risankizumab studies M16-006, M15-991 or M15-989.