Phase 2
Completed N=224
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov NCT00659802 ↗Enrolled (actual)
224
Serious AEs
2.7%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With a Clinical Response at Week 8 — 33; 45; 30 Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Clinical Response at Week 8 |
33; 45; 30 | — |
| SECONDARY Number of Participants With a Clinical Remission at Week 8 |
25; 28; 19 | — |
| SECONDARY Number of Participants With Mucosal Healing at Week 8 |
28; 37; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Have active confirmed mild to moderate ulcerative colitis
Exclusion Criteria
- Diagnosed with Crohn's Disease or
Data sourced from ClinicalTrials.gov (NCT00659802). 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.