Phase 2 N=224 Randomized Quadruple-blind Treatment

Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT00659802 ↗

Enrolled (actual)

224

Serious AEs

2.7%

Results posted

Jul 2020

Primary outcome: Primary: Number of Participants With a Clinical Response at Week 8 — 33; 45; 30 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: HMPL-004 low dose (Drug); Placebo (Drug); HMPL-004 high dose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hutchison Medipharma Limited
Primary completion: Oct 2009

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	—

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.

Eligibility Criteria

Inclusion Criteria

Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria

Diagnosed with Crohn's Disease or

View full record on ClinicalTrials.gov →

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.