Phase 2
Completed N=101
Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT00655733 ↗Enrolled (actual)
101
Serious AEs
5.9%
Results posted
Dec 2012
Primary outcomePrimary: CDAI Clinical Response -100 at Week 8 — 19; 11 Participants
Summary
A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CDAI Clinical Response -100 at Week 8 |
19; 11 | — |
| SECONDARY Clinical Response -100 at Weeks 4 |
15; 13 | — |
| SECONDARY Clinical Response -100 at Weeks 12 |
17; 11 | — |
| SECONDARY Remission at Week 4 |
8; 8 | — |
| SECONDARY Remission at Week 8 |
15; 7 | — |
| SECONDARY Remission at Week 12 |
10; 7 | — |
| SECONDARY Clinical Response -70 at Week 4 |
20; 19 | — |
| SECONDARY Clinical Response -70 at Week 8 |
25; 16 | — |
| SECONDARY Clinical Response -70 at Week 12 |
20; 18 | — |
| SECONDARY Complete Remission at Week 4 |
8; 8 | — |
| SECONDARY Complete Remission at Week 8 |
13; 7 | — |
| SECONDARY Complete Remission at Week 12 |
9; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen
Exclusion Criteria
- They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication
Data sourced from ClinicalTrials.gov (NCT00655733). 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.