Intravenous Steroid-Refractory Ulcerative ColitisPhase 3NCT00502294
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
A Phase 3 study testing Visilizumab (HuM291; Nuvion®) in people with Intravenous Steroid-Refractory Ulcerative Colitis, run by Facet Biotech.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Steroid-Refractory Ulcerative Colitis
- What is being tested?
- Visilizumab (HuM291; Nuvion®)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 years of age or older.
- Diagnosis of UC verified by endoscopy within 60 months prior to consent.
Who cannot join
None listed.
About this study
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.
- Being tested
- Visilizumab (HuM291; Nuvion®)
- Keywords
- Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visilizumab (HuM291; Nuvion®)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Steroid-Refractory Ulcerative ColitisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PDL BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502294
- Sponsor's protocol ID
- 291-416
- Status last verified
- Jul 2008
- First submitted
- 13 Jul 2007
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00502294
- Acronym / sponsor ID
- 291-416
- Keywords
- Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Collaborators
- PDL BioPharma, Inc.
- First posted
- 17 Jul 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females, 18 years of age or older.
- Diagnosis of UC verified by endoscopy within 60 months prior to consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Visilizumab (HuM291; Nuvion®) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Visilizumab (HuM291; Nuvion®) in people with Intravenous Steroid-Refractory Ulcerative Colitis, run by Facet Biotech.
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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 25 Jun 2009.