Ulcerative ColitisPhase 2NCT00307827
Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
A Phase 2 study testing Visilizumab in people with Ulcerative Colitis, run by Abbott at 16 sites in 6 countries.
Trial summary
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Apr 2006to Nov 2007
- Phase
- Phase 2
- 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
- Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Males and females, 18 years of age or older.
- Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent.
- Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) >= 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.
Show all 9Show fewer
- Negative serum pregnancy test at screening.
- Negative Clostridium difficile test within 10 days prior to randomization.
- Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
Who cannot join
- Subjects will be ineligible for this study if they meet any one of the following criteria:
- UC requiring immediate 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.
Show all 17Show fewer
- Live vaccination within 6 weeks prior to randomization.
- Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
- 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-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a 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.
- Unwilling or unable to discontinue all UC drugs, except glucocorticoids and oral 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
16 sites in 6 countries.
16 sites in 6 countries
United States5 sites
Site Reference ID/Investigator# 71895
Chapel Hill, North Carolina, 27599-7032
Site Reference ID/Investigator# 71896
Cleveland, Ohio, 44106-5066
Site Reference ID/Investigator# 71913
Manhasset, New York, 11030
Site Reference ID/Investigator# 71894
Savannah, Georgia, 31405
Site Reference ID/Investigator# 71897
Worcester, Massachusetts, 01655
Russia4 sites
Site Reference ID/Investigator# 72314
Moscow, 111123
Site Reference ID/Investigator# 71953
Nizhny Novgorod, 603126
Site Reference ID/Investigator# 72315
Saint Petersburg, 196247
Site Reference ID/Investigator# 72342
Saint Petersburg
Canada2 sites
Site Reference ID/Investigator# 71875
Hamilton, L8N 3Z5
Site Reference ID/Investigator# 71873
Winnipeg, R3A 1R9
Croatia2 sites
Site Reference ID/Investigator# 72338
Osijek, 31 000
Site Reference ID/Investigator# 72334
Zagreb, 10000
Spain2 sites
Site Reference ID/Investigator# 72368
Badalona - Barcelona, 08916
Site Reference ID/Investigator# 72366
Majadahonda (Madrid), 28222
About this study
Official title: A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
Read the detailed description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
- Conditions
- Ulcerative Colitis
- Being tested
- Visilizumab
- Keywords
- Steroid-Refractory, IVSR-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.
VisilizumabDrug
Also called Nuvion®; HuM291
Visilizumab administered intravenously once per day for two days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Visilizumab low dose level Receives: Drug: Visilizumab |
| Arm 2 | Experimental | Visilizumab middle dose level Receives: Drug: Visilizumab |
| Arm 3 | Experimental | Visilizumab high dose level Receives: Drug: Visilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).
Measured: Day 45
Secondary outcomes (1)
Comparison of subjects in the three visilizumab dose groups
Measured: During the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Study Canceled
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307827
- Sponsor's protocol ID
- 291-418
- Other IDs
- 2005-003482-17, 2005
- Status last verified
- Apr 2012
- First submitted
- 24 Mar 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00307827
- Acronym / sponsor ID
- 291-418
- Conditions
- Ulcerative Colitis
- Keywords
- Steroid-Refractory, IVSR-UC, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Canceled
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Mar 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 assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: VisilizumabVisilizumab low dose level |
| Arm 2 | Experimental | Drug: VisilizumabVisilizumab middle dose level |
| Arm 3 | Experimental | Drug: VisilizumabVisilizumab high dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Males and females, 18 years of age or older.
- Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent.
- Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) >= 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.
Key exclusion criteria (17 listed)
- Subjects will be ineligible for this study if they meet any one of the following criteria:
- UC requiring immediate 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.
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 |
|---|---|---|
| VisilizumabAlso: Nuvion®; HuM291Visilizumab administered intravenously once per day for two days | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).
Time frame: Day 45
1 secondary outcome
Comparison of subjects in the three visilizumab dose groups
Time frame: During the course of the study
Results and safety
The study was stopped early (reason given: Study Canceled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Mihail Obrocea, MD study director
Abbott
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visilizumab in people with Ulcerative Colitis, run by Abbott at 16 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 9 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Russia, Canada, Croatia, Spain 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study Canceled). 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.
What does the primary outcome measure?
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1). (time frame: Day 45). 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 27 Apr 2012.