A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis
2 other identifiers
interventional
48
6 countries
30
Brief Summary
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2008
Longer than P75 for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 2, 2016
November 1, 2016
3 years
June 7, 2008
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence and nature of laboratory abnormalities
Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Through study completion or early study discontinuation
Secondary Outcomes (2)
PK profile and parameters
Through study completion or early study discontinuation
Incidence of antibodies directed against rhuMAb Beta7
Through study completion or early study discontinuation
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide written informed consent
- years of age
- Males and females with reproductive potential: Willing to use a reliable method of contraception
- Diagnosis of ulcerative colitis
- Eligible to receive biologic therapy
- Disease duration of \>=12 weeks
You may not qualify if:
- Requirement for hospitalization due to severity of ulcerative colitis
- Moderate to severe anemia
- Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with \>20 mg/day of prednisone, or prednisone equivalent, during the course of the study
- Pregnant or lactating
- Lack of peripheral venous access
- Inability to comply with study protocol
- History or presence of contraindicated diseases
- Congenital immune deficiency
- Active or prior infection with HIV or hepatitis B or C
- History of severe systemic bacterial, fungal, viral, or parasitic infections
- History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
- Received a live attenuated vaccine within 4 weeks prior to screening
- Hospitalized within 4 weeks prior to screening
- Received any contraindicated therapy within 12 weeks prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (30)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Lexington, Kentucky, 40536, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Great Neck, New York, 11021, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Calgary, Alberta, T2N 2T9, Canada
Unknown Facility
Edmonton, Alberta, T6G 2X8, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2K5, Canada
Unknown Facility
Victoria, British Columbia, V8V 3P9, Canada
Unknown Facility
London, Ontario, N6A 4L6, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Frankfurt, 60431, Germany
Unknown Facility
Kiel, 24105, Germany
Unknown Facility
Regensburg, 93053, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Leiden, 2333 ZA, Netherlands
Unknown Facility
Maastricht, 6229 HX, Netherlands
Unknown Facility
Nijmegen, 6525 GA, Netherlands
Unknown Facility
Utrecht, 3584 CX, Netherlands
Unknown Facility
Bristol, BS2 8HW, United Kingdom
Unknown Facility
London, SE1 7EH, United Kingdom
Unknown Facility
London, SW10 9NH, United Kingdom
Unknown Facility
London, W12 0HS, United Kingdom
Unknown Facility
Newcastle upon Tyne, NE1 4LP, United Kingdom
Unknown Facility
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2008
First Posted
June 11, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11