Phase 3
N=1,012
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02435992 ↗Enrolled (actual)
1,012
Serious AEs
5.5%
Results posted
Sep 2021
Primary outcome: Primary: Percentage of Participants in Clinical Remission at 10 Weeks — 18.4; 6.0; 21.0 Percentage — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RPC1063 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Mar 2020
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 | — |
Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
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). 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.