A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502294

Enrollment

150

Registered

2007-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Steroid-Refractory Ulcerative Colitis

Keywords

Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC

Brief summary

To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

Interventions

DRUGVisilizumab (HuM291; Nuvion®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and females, 18 years of age or older. * Diagnosis of UC verified by endoscopy within 60 months prior to consent.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026