Ulcerative ColitisPhase 2/3NCT00279422
A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
A Phase 2/3 study testing visilizumab in people with Ulcerative Colitis, run by Facet Biotech at 70 sites in 14 countries.
Trial summary
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis. 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
- 127 participants
- Where
- 70 sitesin 14 countries
- Study dates
- Feb 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.
- Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
- Severe active disease, as defined by a Modified Truelove \& Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
- Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
- 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 intervention or toxic megacolon requiring imminent intervention.
- History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
- Presence of Ileostomy.
- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL.
- Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
- Live vaccination within 6 weeks prior to randomization.
Show all 17Show fewer
- Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
- History of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
- History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
- Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
- Pregnancy or nursing.
- Treatment with a first dose of infliximab or another anti-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
- Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
- Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above.
- Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, immediately prior to randomization.
- Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
Trial locations and contacts
70 sites in 14 countries.
70 sites in 14 countries
United States18 sites
Study site
Atlanta, Georgia, 30342
Study site
Boston, Massachusetts, 02115
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60637
Study site
Gainesville, Florida, 32608
Study site
Galveston, Texas, 77555-0764
Study site
Indianapolis, Indiana, 46202
Study site
Lexington, Kentucky, 40536
Study site
Los Angeles, California, 90048
Study site
Louisville, Kentucky, 40202
Study site
Macon, Georgia, 31201
Study site
Nashville, Tennessee
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
Pittsburgh, Pennsylvania
Study site
Rochester, Minnesota, 55905
Study site
San Francisco, California, 94115
Study site
Tampa, Florida, 33606
Australia9 sites
Study site
Bedford Park, 5042
Study site
Box Hill, Victoria, 3128
Study site
Camperdown, New South Wales, 2050
Study site
Fitzroy
Study site
Fremantle, 6160
Study site
Herston, Queensland, 4029
Study site
Liverpool, New South Wales, 2170
Study site
Parkville
Study site
South Brisbane, Queensland
Germany8 sites
Study site
Berlin, 13353
Study site
Frankfurt, D-60431
Study site
Freiburg im Breisgau
Study site
Hanover, 30625
Study site
Kiel, 24105
Study site
München
Study site
Rostock, 18055
Study site
Stuttgart, 70376
Hungary8 sites
Study site
Argenti Döme, 2601
Study site
Budapest, H-1083
Study site
Budapest, H-1088
Study site
Csabai Kapu, 3501
Study site
Debrecen, H-4012
Study site
Győr, Vasvári Pál, 9024
Study site
Szekszárd, H-7100
Study site
Veszprém, H-8220
France7 sites
Study site
Amiens, Cedex, 80054
Study site
Clichy, 92110
Study site
Lille, 59037
Study site
Marseille
Study site
Nantes
Study site
Nice
Study site
Paris
Belgium3 sites
Study site
Ghent, B-9000
Study site
Leuven, 3000
Study site
Roeselare
Israel3 sites
Study site
Haifa
Study site
Tel Aviv, 64329
Study site
Tel HaShomer, 52621
Norway3 sites
Study site
Oslo, N-0027
Study site
Prinsens
Study site
Tromsø, 9038
Ukraine3 sites
Study site
Kharkiv, 61001
Study site
Kyiv, 01021
Study site
Odesa, 65025
Canada2 sites
Study site
Calgary, Alberta, T2N 4N1
Study site
London, Ontario, N685W9
About this study
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Read the detailed description
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
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 startFeb 2006
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: DMC recommendation, no efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 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
- NCT00279422
- Sponsor's protocol ID
- 291-415
- Status last verified
- Mar 2012
- First submitted
- 17 Jan 2006
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.
PubMed 20947884
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 Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00279422
- Acronym / sponsor ID
- 291-415
- Conditions
- Ulcerative Colitis
- Keywords
- Intravenous, Steroid-Refractory, Ulcerative Colitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMC recommendation, no efficacy
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Collaborators
- PDL BioPharma, Inc.
- Study start
- Feb 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 of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Detailed description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 (8 listed)
- Males and females, 18 years of age or older.
- Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
- Severe active disease, as defined by a Modified Truelove \& Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
- Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
- Adequate contraception from the day of consent through 3 months after the last dose of study drug.
Key exclusion criteria (17 listed)
- UC requiring immediate intervention or toxic megacolon requiring imminent intervention.
- History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
- Presence of Ileostomy.
- White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL.
- Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
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 | visilizumab |
| visilizumab | Drug | placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: DMC recommendation, no efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Derived from this study: PubMed 20947884Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.
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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.
70 sites in 14 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 70 sites in 14 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 8 inclusion and 17 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 70 sites in United States, Australia, Germany, Hungary, France and 9 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: DMC recommendation, no efficacy). 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?
On the ClinicalTrials.gov record for NCT00279422, which also lists 1 linked publication.
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.