NCT00307827

Brief Summary

The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
6 countries

16 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1.6 years

First QC Date

March 24, 2006

Last Update Submit

April 26, 2012

Conditions

Ulcerative Colitis

Keywords

Steroid-RefractoryIVSR-UCUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).

    Day 45

Secondary Outcomes (1)

  • Comparison of subjects in the three visilizumab dose groups

    During the course of the study

Study Arms (3)

Arm 1

EXPERIMENTAL

Visilizumab low dose level

Drug: Visilizumab

Arm 2

EXPERIMENTAL

Visilizumab middle dose level

Drug: Visilizumab

Arm 3

EXPERIMENTAL

Visilizumab high dose level

Drug: Visilizumab

Interventions

VisilizumabDRUG

Visilizumab administered intravenously once per day for two days

Also known as: Nuvion®; HuM291
Arm 1Arm 2Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, 18 years of age or older.
  • Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent.
  • Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) \>= 11 at consent, with a confirmatory MTWSI \>= 10 on or after the fifth consecutive day of intravenous (IV) steroids and within 1 day prior to randomization.
  • Mayo score \>= 10 and Mayo mucosal subscore \>= 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
  • Adequate contraception from the day of consent through 3 months after the last dose of study drug.
  • Negative serum pregnancy test at screening.
  • Negative Clostridium difficile test within 10 days prior to randomization.
  • Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

You may not qualify if:

  • Subjects will be ineligible for this study if they meet any one of the following criteria:
  • UC requiring immediate intervention.
  • History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis
  • Presence of ileostomy.
  • White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin level less than 8 g/dL.
  • Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
  • Live vaccination within 6 weeks prior to randomization.
  • Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
  • History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
  • Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
  • Pregnancy or nursing.
  • Treatment with a first dose of infliximab or another anti-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a drug within 2 weeks of randomization.
  • Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
  • Unwilling or unable to discontinue all UC drugs, except glucocorticoids and oral 5-ASA, immediately prior to randomization.
  • Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Site Reference ID/Investigator# 71894

Savannah, Georgia, 31405, United States

Location

Site Reference ID/Investigator# 71897

Worcester, Massachusetts, 01655, United States

Location

Site Reference ID/Investigator# 71913

Manhasset, New York, 11030, United States

Location

Site Reference ID/Investigator# 71895

Chapel Hill, North Carolina, 27599-7032, United States

Location

Site Reference ID/Investigator# 71896

Cleveland, Ohio, 44106-5066, United States

Location

Site Reference ID/Investigator# 71875

Hamilton, L8N 3Z5, Canada

Location

Site Reference ID/Investigator# 71873

Winnipeg, R3A 1R9, Canada

Location

Site Reference ID/Investigator# 72338

Osijek, 31 000, Croatia

Location

Site Reference ID/Investigator# 72334

Zagreb, 10000, Croatia

Location

Site Reference ID/Investigator# 72345

Bologna, 40138, Italy

Location

Site Reference ID/Investigator# 72314

Moscow, 111123, Russia

Location

Site Reference ID/Investigator# 71953

Nizhny Novgorod, 603126, Russia

Location

Site Reference ID/Investigator# 72315

Saint Petersburg, 196247, Russia

Location

Site Reference ID/Investigator# 72342

Saint Petersburg, Russia

Location

Site Reference ID/Investigator# 72368

Badalona - Barcelona, 08916, Spain

Location

Site Reference ID/Investigator# 72366

Majadahonda (Madrid), 28222, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

visilizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Mihail Obrocea, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

ES(2)RU(4)CA(2)US(5)CR(2)IT(1)