Yellowstone - A new treatment for Crohn’s Disease

Crohn’s Disease

Crohn’s disease is a chronic disease  that causes inflammation (swelling) in the bowel. People with Crohn’s disease often suffer from diarrhoea, abdominal pain, rectal bleeding, weight loss, and fever. There is no cure for Crohn’s disease. Available treatments only to help control the disease.

Ozanimod  is a chemical compound that is thought to act on the immune system by making certain types of white blood cells stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation.

The purpose of this study is to see whether ozanimod is safe and effective for treatment of Crohn’s disease.

Category
Trial Status
Active, not recruiting
Trial Phase
Phase 3 Drug Trial
Trial contact details
Contact Person
IBD Clinical Trials Unit
What you need to know

Who can take part?

Inclusion

  • Participants aged 12 to 75 years with a body weight ≥ 45 kg
  • Diagnosis of Crohn’s Disease for at least 3 months

Exclusion

  • Certain underlying health conditions may make you ineligible to participate
  • Previous surgical intervention for Crohn’s Disease
  • Current or recent infection
  • Pregnant or breastfeeding women may not participate
  • Previous cancer diagnosis
  • Some medications may make you ineligible to participate

What is involved for you?

  • Medical history and collection of demographic information
  • Vital signs
  • Electrocardiogram
  • Physical exam
  • Blood and urine tests
  • Pregnancy tests in women of childbearing potential
  • Stool tests
  • Colonoscopy with colon tissue biopsy
  • Eye exam
  • Lung function test
  • Daily diary completion
  • Questionnaires
  • Daily oral treatment

Trial dates

Sep 2019 – Dec 2023

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