CompletedNCT00694980Updated Nov 2, 2016

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

A Phase 1 interventional study of placebo and rhuMAb Beta7 in Ulcerative Colitis, sponsored by Genentech, Inc.. Completed at 30 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

Conditions studied

Ulcerative Colitis

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Keywords

UC
Ulcerative Colitis

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 771 interventional studies indexed under Colitis.

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Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Able and willing to provide written informed consent
18-70 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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 48 participants (actual)

Study arms

Experimental
1
Drug: placebo · Drug: rhuMAb Beta7

Interventions

Drugplacebo
Intravenous and subcutaneous escalating doses
DrugrhuMAb Beta7
Intravenous and subcutaneous escalating doses

What researchers measure

Primary outcomes

Incidence and nature of laboratory abnormalities
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation

Secondary outcomes

PK profile and parameters
Time frame: Through study completion or early study discontinuation
Incidence of antibodies directed against rhuMAb Beta7
Time frame: Through study completion or early study discontinuation

Study locations

30 sites

Anniston, Alabama 36207, United States
San Francisco, California 94115, United States
Gainesville, Florida 32610, United States
Atlanta, Georgia 30308, United States
Lexington, Kentucky 40536, United States
Rochester, Minnesota 55905, United States
Great Neck, New York 11021, United States
Chapel Hill, North Carolina 27599, United States
Leuven, 3000, Belgium
Calgary, Alberta T2N 2T9, Canada
Edmonton, Alberta T6G 2X8, Canada
Vancouver, British Columbia V6Z 2K5, Canada
Victoria, British Columbia V8V 3P9, Canada
London, Ontario N6A 4L6, Canada
Montreal, Quebec H1T 2M4, Canada
Berlin, 13353, Germany
Frankfurt, 60431, Germany
Kiel, 24105, Germany
Regensburg, 93053, Germany
Ulm, 89081, Germany
Leiden, 2333 ZA, Netherlands
Maastricht, 6229 HX, Netherlands
Nijmegen, 6525 GA, Netherlands
Utrecht, 3584 CX, Netherlands
Bristol, BS2 8HW, United Kingdom
London, SE1 7EH, United Kingdom
London, SW10 9NH, United Kingdom
London, W12 0HS, United Kingdom
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham, NG7 2UH, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00694980
Lead sponsor: Genentech, Inc.
Responsible party: Sponsor
First posted: Jun 11, 2008
Start date: Sep 2008
Primary completion: Sep 2011
Completion: Sep 2012
Last update: Nov 2, 2016

Study contacts

Clinical Trials

study director · Genentech, Inc.

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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