Ozanimod for Ulcerative Colitis

No longer recruiting at 179 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bristol-Myers Squibb

Disqualifiers: Fulminant colitis, Toxic megacolon, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ozanimod, a medication for individuals with moderate to severe ulcerative colitis (UC). Researchers aim to evaluate ozanimod's effectiveness, safety, and potential to enhance quality of life for those with UC. Participants are divided into two groups: those who have not tried advanced treatments and those who have. Suitable candidates for this trial include individuals who have experienced UC symptoms for at least three months and have undergone a colonoscopy showing the disease's extent. As a Phase 4 trial, ozanimod has already received FDA approval and proven effective, and this research seeks to understand its benefits for a broader patient population.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Previous studies have shown that ozanimod is safe for treating ulcerative colitis (UC). Research indicates that ozanimod effectively initiates and maintains control of UC symptoms. Patients have used it long-term, and results suggest it is generally well-tolerated. Although side effects occurred, they were usually mild. Since ozanimod is already approved for other conditions, it has a well-established safety record. Overall, existing research suggests that ozanimod is safe for many people with UC. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Ozanimod for ulcerative colitis because it offers a unique way of managing the condition by targeting specific immune system pathways. Unlike standard treatments, which often include corticosteroids and aminosalicylates, Ozanimod is a selective sphingosine-1-phosphate (S1P) receptor modulator. This means it works by preventing certain immune cells from reaching inflamed tissues in the gut, potentially reducing inflammation more effectively and with fewer side effects. This targeted approach could offer a new level of precision in managing ulcerative colitis symptoms.

What is the effectiveness track record for ozanimod in treating ulcerative colitis?

Research has shown that ozanimod works well for treating ulcerative colitis (UC). One study found that ozanimod reduced symptoms and inflammation over a year. Another study demonstrated that ozanimod outperformed a placebo in initiating and maintaining treatment benefits for people with moderate to severe UC. Long-term evidence suggests it remains effective and safe for patients over several years. In this trial, participants will be divided into two cohorts: those who are advanced therapy-naive and those who are advanced therapy-exposed, to further evaluate ozanimod's effectiveness in different patient populations. This treatment has already proven beneficial for people with ulcerative colitis. ^{1 2 3 4 5}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis, confirmed by a colonoscopy within the last 60 days. Participants should have active symptoms for at least 3 months and meet specific disease activity scores. Those with recent severe complications, major surgery on the colon, or unremoved colonic dysplasia cannot join.

Inclusion Criteria

My ulcerative colitis is moderate to severe, based on a specific score.

Report of a previous colonoscopy that documents extent of disease

I have been diagnosed with ulcerative colitis for at least 3 months.

Exclusion Criteria

I have abnormal colon cells that haven't been removed.

I have had severe colon issues or a bowel tear in the last 3 months.

I have had a major surgery to remove part of my colon or I currently have a stoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ozanimod to explore safety, efficacy, and biomarker response

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Long-term follow-up

Participants are monitored for long-term safety and adverse events

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Ozanimod

Trial Overview The study is testing Ozanimod's effects on safety, effectiveness in controlling UC symptoms, impact on quality of life, and changes in biomarkers that indicate disease activity among patients as they receive treatment during regular clinical care.

How Is the Trial Designed?

Group I: Cohort 2 - Advanced therapy-exposed Experimental Treatment 1 Intervention

Group II: Cohort 1 - Advanced therapy-naive Experimental Treatment 1 Intervention

Ozanimod is already approved in European Union, United States for the following indications:

Approved in European Union as Ozanimod for:

• Moderate to severe active ulcerative colitis

Approved in United States as Ozanimod for:

• Moderate to severe active ulcerative colitis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38087126/

Real World Clinical Effectiveness and Safety of Ozanimod ... Ozanimod effectively induced clinical response and remission patients with largely treatment refractory UC, however, had modest long-term ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8256627/

Long-Term Efficacy and Safety of Ozanimod in Moderately to ... This analysis examined the long-term safety and efficacy of ozanimod in patients with moderately to severely active ulcerative colitis [UC] with ≥ 4 years ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02531126

NCT02531126 | An Extension Study of RPC1063 as ... The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2033617

Ozanimod as Induction and Maintenance Therapy for ... Ozanimod was more effective than placebo as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis.

5. zeposia.com zeposia.com/ulcerative-colitis/efficacy-and-study-results

Clinical Studies Results | ZEPOSIA® (ozanimod) Achieve lasting remission with ZEPOSIA (fewer symptoms and reduced inflammation seen during a colonoscopy at 1 year).