Phase 3
Completed N=1,012
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov NCT02435992 ↗Enrolled (actual)
1,012
Serious AEs
5.5%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants in Clinical Remission at 10 Weeks — 18.4; 6.0; 21.0 Percentage — p=0.0001
◆ Published Evidence
Established
22citations · ~11 / year
Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies.
Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Linked Publications (5)
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Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies.
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Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.
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Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial.
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Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis.
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Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Clinical Remission at 10 Weeks |
18.4; 6.0; 21.0 | 0.0001 sig |
| PRIMARY Percentage of Participants in Clinical Remission at 52 Weeks |
24.6; 37.0; 18.5 | 0.0001 sig |
| SECONDARY Percentage of Participants With Clinical Response at 10 Weeks |
47.8; 25.9; 52.6 | — |
| SECONDARY Percentage of Participants With Endoscopic Improvement at 10 Weeks |
27.3; 11.6; 27.2 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at 10 Weeks |
12.6; 3.7; 11.4 | — |
| SECONDARY Percentage of Participants in Clinical Response at 52 Weeks |
39.1; 60.0; 41.0 | — |
| SECONDARY Percentage of Participants With Endoscopic Improvement at 52 Weeks |
29.0; 45.7; 26.4 | — |
| SECONDARY Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 |
41.7; 51.9; 29.3 | — |
| SECONDARY Percentage of Participants With Corticosteroid Free Remission at 52 Weeks |
24.6; 31.7; 16.7 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at 52 Weeks |
10.1; 29.6; 14.1 | — |
| SECONDARY Percentage of Participants With Durable Clinical Remission at 52 Weeks |
7.2; 17.8; 9.7 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 to 75 years (at screening for Cohort 1 and 2)
- UC confirmed on endoscopy
- Moderately to severely active UC (May score 6-12)
- Currently receiving treatment with aminosalisylate, prednisone, or budesonide
- Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
Exclusion Criteria
- Have severe extensive colitis as evidence by:
- Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
- Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
- Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
- Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
- History of uveitis or unknown macular edema
- Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Data sourced from ClinicalTrials.gov (NCT02435992) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.