Phase 2
Completed N=69
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT02531113 ↗Enrolled (actual)
69
Serious AEs
26.1%
Results posted
Oct 2020
Primary outcomePrimary: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader. — -2.3 Units on a Scale
Summary
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader. |
-2.3 | — |
| SECONDARY The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period |
59; 43; 15; 24; 7; 18 | — |
Eligibility Criteria
Key Inclusion Criteria
- Crohn's disease (CD) confirmed by endoscopy and histology
- Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
- Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy
Key Exclusion Criteria
- Diagnosis of ulcerative colitis or indeterminate colitis
- Known strictures/stenosis leading to symptoms of obstruction
- Current stoma or need for ileostomy or colostomy
- 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 known macular edema
- History of colonic dysplasia
Data sourced from ClinicalTrials.gov (NCT02531113). 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.