Ulcerative ColitisPhase 1NCT00694980
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
A Phase 1 study testing rhuMAb Beta7 in people with Ulcerative Colitis, run by Genentech, Inc. at 30 sites in 6 countries.
Trial summary
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- rhuMAb Beta7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 30 sitesin 6 countries
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
United States8 sites
Study site
Anniston, Alabama, 36207
Study site
Atlanta, Georgia, 30308
Study site
Chapel Hill, North Carolina, 27599
Study site
Gainesville, Florida, 32610
Study site
Great Neck, New York, 11021
Study site
Lexington, Kentucky, 40536
Study site
Rochester, Minnesota, 55905
Study site
San Francisco, California, 94115
Canada6 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2X8
Study site
London, Ontario, N6A 4L6
Study site
Montreal, Quebec, H1T 2M4
Study site
Vancouver, British Columbia, V6Z 2K5
Study site
Victoria, British Columbia, V8V 3P9
United Kingdom6 sites
Study site
Bristol, BS2 8HW
Study site
London, SE1 7EH
Study site
London, SW10 9NH
Study site
London, W12 0HS
Study site
Newcastle upon Tyne, NE1 4LP
Study site
Nottingham, NG7 2UH
Germany5 sites
Study site
Berlin, 13353
Study site
Frankfurt, 60431
Study site
Kiel, 24105
Study site
Regensburg, 93053
Study site
Ulm, 89081
Netherlands4 sites
Study site
Leiden, 2333 ZA
Study site
Maastricht, 6229 HX
Study site
Nijmegen, 6525 GA
Study site
Utrecht, 3584 CX
About this study
Official title: 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
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- placebo, rhuMAb Beta7
- Keywords
- UC, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Intravenous and subcutaneous escalating doses
rhuMAb Beta7Drug
Intravenous and subcutaneous escalating doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: placebo; Drug: rhuMAb Beta7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of laboratory abnormalities
Measured: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
Secondary outcomes (2)
PK profile and parameters
Measured: Through study completion or early study discontinuation
Incidence of antibodies directed against rhuMAb Beta7
Measured: Through study completion or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694980
- Sponsor's protocol ID
- ABS4262g
- Other IDs
- GA00930
- Status last verified
- Nov 2016
- First submitted
- 7 Jun 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00694980
- Acronym / sponsor ID
- ABS4262g
- Conditions
- Ulcerative Colitis
- Keywords
- UC, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: placebo, Drug: rhuMAb Beta7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboIntravenous and subcutaneous escalating doses | Drug | 1 |
| rhuMAb Beta7Intravenous and subcutaneous escalating doses | Drug | 1 |
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhuMAb Beta7 in people with Ulcerative Colitis, run by Genentech, Inc. at 30 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, United Kingdom, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of laboratory abnormalities (time frame: Through study completion or early study discontinuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.