This study focuses on Crohn’s Disease, specifically its moderate to severe form, which is a long-term condition causing inflammation of the digestive system. The study examines ozanimod, a medication taken by mouth in the form of capsules, to determine if it can help maintain improvement in patients who have already shown positive response to initial treatment.
The research aims to show how well ozanimod works compared to placebo in maintaining disease remission (a state where symptoms are minimal or absent) and improving the appearance of the intestinal lining when viewed through medical examination. The medication will be given as hard capsules that patients take by mouth. Some participants will receive ozanimod while others will receive placebo capsules that look identical to the real medication.
During the study, participants will be monitored for about one year to assess how well the treatment maintains control of their disease symptoms. The study will track various aspects of the disease, including stomach pain, bowel movements, and the condition of the intestinal lining. The maximum daily dose of ozanimod used in the study is 0.92 mg.
1Initial assessment
After completing the 12-week induction study, your eligibility for the maintenance study will be evaluated based on your response to previous treatment.
You must show a reduction in Crohn’s Disease Activity Index (CDAI) of at least 100 points or have a score below 150 points.
Alternatively, you may qualify if you have an average daily stool frequency score of 3 or less and average abdominal pain score of 1 or less, with neither symptom worse than when you started treatment.
2Treatment assignment
You will be randomly assigned to receive either ozanimod capsules or placebo capsules (capsules without active medication).
The capsules are to be taken by mouth.
Neither you nor your doctor will know which treatment you are receiving.
352-week treatment period
You will take the assigned medication for 52 weeks.
Regular assessments will monitor your CDAI score, abdominal pain, and stool frequency.
An examination of your intestines (endoscopy) will be performed to assess healing.
If you are taking corticosteroids, their use will be monitored during the last 12 weeks of the study.
4Safety monitoring
Your health will be monitored throughout the study period.
Female participants must use effective birth control methods throughout the study and for 90 days after the last dose.
The study will track any worsening of symptoms, including an increase in CDAI score of 100 points or more above starting value and a score greater than 220.
5Final evaluation
At week 52, final assessments will be conducted to evaluate the effectiveness of the treatment.
These include measuring your CDAI score, examining your intestines, and evaluating tissue samples if taken.
The study will assess whether you achieved remission (improvement) of your Crohn’s disease symptoms.
Who Can Join the Study?
Must have completed the 12-week initial treatment phase (Induction Study) and all required assessments at Week 12
Must be able to provide written informed consent and follow all study procedures and visits
Must have achieved one of the following responses after 12 weeks of initial treatment:
A reduction in CDAI (Crohn’s Disease Activity Index) score of at least 100 points
A CDAI score less than 150 points
An average daily stool frequency of 3 or fewer times per day
An average abdominal pain score of 1 or less (on a defined scale)
Women who can become pregnant must agree to use one of these effective birth control methods throughout the study and for 90 days after:
Combined hormonal contraception (pills, vaginal ring, or patch)
Progestogen-only contraception (pills, injection, or implant)
Intrauterine device (IUD)
Intrauterine hormone system (IUS)
Tubal ligation
Partner with vasectomy
Complete sexual abstinence
Both men and women can participate in the study
Who Cannot Join the Study?
Current treatment with medications that suppress the immune system (such as cyclosporine, tacrolimus, or similar drugs)
History of severe allergic reactions to any medications
Active or untreated tuberculosis infection
Presence of serious heart conditions or irregular heart rhythm
Severe liver disease or abnormal liver function tests
Current or recent cancer diagnosis within the past 5 years
Active serious infections requiring treatment
History of certain neurological conditions like multiple sclerosis
Pregnancy or breastfeeding
Uncontrolled high blood pressure
History of blood clotting disorders
Recent major surgery within the past 3 months
Current participation in other clinical trials
Severe kidney disease requiring dialysis
History of organ transplantation
Active substance abuse or addiction
Inability to follow study procedures or attend scheduled visits
Ozanimod is an oral medication used to treat moderate to severe Crohn’s disease. It works by modulating the immune system to reduce inflammation in the digestive tract. This medication helps maintain periods of remission (when symptoms are under control) and improves the appearance of the intestinal lining when viewed through an endoscope. It belongs to a class of drugs called sphingosine 1-phosphate receptor modulators, which help control inflammation by affecting how immune cells move through the body.
Crohn’s Disease – A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly occurs in the small intestine and colon. The inflammation caused by Crohn’s disease often spreads deep into the layers of affected bowel tissue, creating patches of inflamed tissue surrounded by healthy areas. Common symptoms include abdominal pain, diarrhea, fatigue, weight loss, and reduced appetite. The disease typically develops gradually, with symptoms worsening over time if left untreated. The condition can lead to complications such as intestinal strictures, fistulas, and nutritional deficiencies.
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