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Gastroenterology Clinical Trials

SHINE-1

Condition: Ulcerative Colitis

Type of Research: Interventional
Principal Investigator: V. Marc Tsou, MD
Primary Study Coordinator: Erin McAndrews, LPN

Study Specifications: Ulcerative Colitis (UC) is an inflammatory bowel disease (IBD) causing inflammation and ulcers within the digestive tract. Pediatric treatments for UC are limited and lack efficacy, tolerability, and safety. Mirikizumab was developed by Eli Lilly to relieve IBD symptoms; it is currently in Phase III clinical trials. SHINE-1 is a Phase III study intended to evaluate the pharmacokinetic properties of Mirikizumab and the achievement of patients reaching clinical remission status at Week 12 and/or Week 52 of treatment. SHINE-1 will evaluate the safety following Mirikizumab infusions for at least one year after treatment.

Point of Contact for the Study: Erin McAndrews LPN
Email: Erin.McAndrews@chkd.org
Phone: (757) 668-6896


VIVID-1

Condition: Crohn’s Disease

Type of Research: Interventional
Principal Investigator: Sameer Lapsia, MD
Primary Study Coordinator: Erin McAndrews, LPN

Study Specifications: Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract. Crohn's disease can cause abdominal pain, diarrhea, weight loss, anemia, and fatigue. This study will assess efficacy and safety of mirikizumab in patients aged 15 to <18 years of age with moderately to severely active Crohn’s disease who are in remission over the course of about one year.

Point of Contact for the Study: Erin McAndrews, LPN
Email: Erin.McAndrews@chkd.org
Phone: (757) 668-6896


SHINE-ON (AMAZ)

Conditions: Ulcerative Colitis; Crohn’s Disease

Principal Investigator: Sameer Lapsia, MD
Primary Study Coordinator: Erin McAndrews, LPN

Study Specifications: SHINE-ON is an extension study to SHINE-1, evaluating the long-term safety and effectiveness of mirikizumab in children and adolescents with UC or Crohn’s Disease.

Point of Contact for the Study: Erin McAndrews, LPN
Email: Erin.McAndrews@chkd.org
Phone: (757) 668-6896


DEVELOP

Conditions: Inflammatory Bowel Diseases; Crohn’s Disease, Ulcerative Colitis, Indeterminate Colitis

Type of Research: Observational
Principal Investigator: V. Marc Tsou, MD
Primary Study Coordinator: Ashley Vasko, BS

Study Specifications: REMICADE® (infliximab) has been approved for the treatment of children and adults with Crohn’s disease (CD) and adults with ulcerative colitis (US). The DEVELOP registry aims to provide additional information on pediatric IBD following the approval of Remicade indication for pediatric CD in the US and EU.

Point of Contact for the Study: Ashley Vasko BS
Email: Ashley.Vasko@chkd.org
Phone: (757) 668-7176