RPC1063 for Ulcerative Colitis

No longer recruiting at 358 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Must not be taking: Breast cancer resistance inhibitors

Disqualifiers: Cardiovascular conditions, Liver impairment, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the long-term safety and effectiveness of RPC1063, a potential new drug for ulcerative colitis. This condition causes inflammation in the colon, leading to symptoms like frequent diarrhea and abdominal pain. The trial specifically targets individuals who participated in a previous study of this treatment and have moderate to severe symptoms. Participants should not have certain heart or liver issues and cannot be using specific breast cancer medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking breast cancer resistance protein inhibitors.

Is there any evidence suggesting that RPC1063 is likely to be safe for humans?

Research has shown that RPC1063, also known as Ozanimod, is generally safe for people with ulcerative colitis. In one study, 94% of patients continued the treatment for 10 weeks, with only 3.3% stopping due to side effects, indicating that most people tolerate the treatment well. Another study is examining the safety of Ozanimod over a longer period, up to four years, for those with moderate to severe ulcerative colitis. This ongoing research supports its long-term safety. These findings suggest that RPC1063 is safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike most treatments for ulcerative colitis, which include anti-inflammatory drugs like mesalamine, corticosteroids, and immunosuppressants, RPC1063 (Ozanimod) works by targeting a specific mechanism in the immune system. It is a selective sphingosine 1-phosphate (S1P) receptor modulator, which helps reduce inflammation by preventing certain immune cells from reaching the gut where they cause damage. Researchers are excited about Ozanimod because it offers a potentially more targeted approach, which might mean fewer side effects and better outcomes for patients. Additionally, because it is an oral medication, it may be more convenient compared to some existing treatments that require injections or infusions.

What evidence suggests that RPC1063 might be an effective treatment for ulcerative colitis?

Studies have shown that ozanimod, also known as RPC1063, effectively treats moderate to severe ulcerative colitis. Research indicates that it reduces symptoms and inflammation, observable during a colonoscopy after one year. Patients who took ozanimod experienced more benefits than those who took a placebo. Additionally, long-term studies have demonstrated that ozanimod remains safe and effective over several years. Overall, ozanimod has successfully helped patients achieve lasting symptom relief and better manage their condition. ^{2 6 7 8 9}

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 who have already been part of earlier RPC1063 trials. They must meet the criteria from their previous participation to join this extension study.

Inclusion Criteria

If you want to know more about participating in a clinical trial with Bristol-Myers Squibb, visit www.BMSStudyConnect.com.

• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants continue to receive RPC1063 for long-term safety and efficacy evaluation

Until March 2023 or until the Sponsor discontinues the development program

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RPC1063

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called RPC1063 in patients with ulcerative colitis who've used it before in prior studies.

How Is the Trial Designed?

Group I: RPC0163 (Ozanimod) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven 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. clinicaltrials.gov clinicaltrials.gov/study/NCT02435992?term=AREA%5BBasicSearch%5D(RPC1063)&rank=7&tab=results

Study Results | Safety and Efficacy Trial of RPC1063 for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. 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.

4. 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).

5. 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 ...

6. zeposia.com zeposia.com/ulcerative-colitis/side-effects

Safety and Side Effects At 10 weeks of treatment, 94% of patients remained on ZEPOSIA in the UC clinical studies, and 3.3% stopped due to a side effect they experienced (N=429).

7. zeposiahcp.com zeposiahcp.com/multiple-sclerosis/clinical-data/safety

ZEPOSIA® (ozanimod) MS Safety Profile | HCPs Safety of long-term ozanimod treatment for up to 4 years in patients with moderately to severely active ulcerative colitis: an interim analysis of the True ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01647516

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

9. sciencedirect.com sciencedirect.com/science/article/pii/S1542356524004051

Ozanimod in Patients With Moderate to Severe Ulcerative ... The pivotal phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod in patients with moderately to severely active ulcerative colitis ...