Ulcerative ColitisPhase 2/3NCT00279435
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
A Phase 2/3 study testing visilizumab in people with Ulcerative Colitis, run by Facet Biotech at 39 sites in 15 countries.
Trial summary
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- visilizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 39 sitesin 15 countries
- Study dates
- Aug 2006to Aug 2007
- Phase
- Phase 2/3
- 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.
- Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
- Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
- Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject's best response on the parent study, an MTWSI score of ≥9, sustained for at least 2 assessments performed at least 1 week apart, and a confirmatory MTWSI ≥8 within 1 day prior to randomization.
- CD4^+ T-cell count ≥ 200 cells/mcL at screening for this protocol, or ≥ 80% of the subject's screening baseline count prior to enrollment on the parent study.
- Mayo assessment (including flexible sigmoidoscopy) performed by a trained, blinded evaluating physician within 2 weeks prior to randomization.
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- Adequate contraception from the day of consent through 3 months after the last dose of study drug.
- Negative serum pregnancy test.
- Negative Clostridium difficile test.
- Signed and dated informed consent, and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
Who cannot join
- UC requiring immediate surgical, endoscopic, or radiologic interventions.
- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin less than 8 g/dL.
- Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
- Live vaccination within 6 weeks prior to randomization.
- Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
- History of lymphoproliferative disorder (LPD) or malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix that has been adequately treated within the past five years.
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- Seropositive for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
- Pregnancy or nursing.
- Treatment with any other UC salvage drugs (including but not limited to infliximab or another anti-TNF-a drug, cyclosporine, tacrolimus [FK506], adalimumab, thalidomide, or another experimental agent), or therapies (surgery, pheresis, affinity columns) since the first course of treatment with study drug in the parent visilizumab study.
- Treatment with any other investigational drug or therapy within 60 days prior to randomization.
- Nontherapeutic levels of chronic antiseizure medications in subjects with a history of seizures.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
Trial locations and contacts
39 sites in 15 countries.
39 sites in 15 countries
United States9 sites
Study site
Atlanta, Georgia, 30342
Study site
Boston, Massachusetts, 02118
Study site
Hershey, Pennsylvania, 17033
Study site
Louisville, Kentucky, 40202
Study site
Murray, Utah, 84107
Study site
Nashville, Tennessee, 37232-2285
Study site
New York, New York, 10029
Study site
Pittsburgh, Pennsylvania, 15261
Study site
Worcester, Massachusetts, 01655
Australia4 sites
Study site
Box Hill, Victoria, 3128
Study site
Fremantle, 6160
Study site
Herston, QLD 4029
Study site
Liverpool, 2170
Hungary4 sites
Study site
Csabai Kapu, H-3501
Study site
Szekszárd
Study site
Vác, H-2601
Study site
Vasvári Pál, H-9024
Canada3 sites
Study site
Calgary, T2N 4N1
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Winnipeg, Manitoba, R3A 1R9
France3 sites
Study site
Clichy, 92110
Study site
Lille, 59037
Study site
Paris, 75010
Germany3 sites
Study site
Berlin, D-13353
Study site
Freiburg im Breisgau, D-79106
Study site
Kiel, D-24105
About this study
Official title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
Read the detailed description
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
- Conditions
- Ulcerative Colitis
- Being tested
- visilizumab
- Keywords
- Intravenous, Steroid-Refractory, 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.
visilizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: visilizumab |
| visilizumab | Experimental | Not described Receives: Drug: visilizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: company decision based on other studies
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PDL BioPharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279435
- Sponsor's protocol ID
- 291-417
- Status last verified
- Mar 2012
- First submitted
- 17 Jan 2006
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
- ClinicalTrials.gov ID
- NCT00279435
- Acronym / sponsor ID
- 291-417
- Conditions
- Ulcerative Colitis
- Keywords
- Intravenous, Steroid-Refractory, Ulcerative Colitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company decision based on other studies
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Collaborators
- PDL BioPharma, Inc.
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Jan 2006 (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.
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
Detailed description
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: visilizumab |
| visilizumab | Experimental | Drug: visilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, 18 years of age or older.
- Only 1 prior treatment course with visilizumab (or placebo in a blinded visilizumab study).
- Response (as defined in parent protocol) of intravenous steroid-refractory ulcerative colitis (IVSR-UC) disease to visilizumab or placebo.
- Symptomatic worsening (ie, an increase of ≥3 points in MTWSI score) from the subject's best response on the parent study, an MTWSI score of ≥9, sustained for at least 2 assessments performed at least 1 week apart, and a confirmatory MTWSI ≥8 within 1 day prior to randomization.
- CD4^+ T-cell count ≥ 200 cells/mcL at screening for this protocol, or ≥ 80% of the subject's screening baseline count prior to enrollment on the parent study.
Key exclusion criteria (12 listed)
- UC requiring immediate surgical, endoscopic, or radiologic interventions.
- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin less than 8 g/dL.
- Active, medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of opportunistic infections within the past 12 months.
- Live vaccination within 6 weeks prior to randomization.
- Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality, history of myocardial infarction, coronary artery disease, congestive heart failure, or arrhythmias within 6 months prior to consent.
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 | Drug | placebo, visilizumab |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: company decision based on other studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing visilizumab in people with Ulcerative Colitis, run by Facet Biotech at 39 sites in 15 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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Australia, Hungary, Canada, France and 10 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: company decision based on other studies). Results are not available in the source record.
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 12 Mar 2012.