Ulcerative ColitisPhase 2NCT01061996
Basiliximab Maintenance in Ulcerative Colitis
A Phase 2 study testing Basiliximab in people with Ulcerative Colitis, run by Cerimon Pharmaceuticals at 1 site in United Kingdom.
Trial summary
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies. Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Basiliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Dec 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously met eligibility criteria in the previous basiliximab UC study
- Must have a total Mayo score at entry consistent with clinical response or clinical remission.
- Signed a current IRB/IEC-approved informed consent form
- Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
Who cannot join
- Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
- Heart rate > 90 beats/min at rest
- Temperature > 37.8 degrees C
- Hemoglobin < 10.5 g/dL
- Subject is currently receiving a restricted/prohibited concomitant medication
- Subject has undergone colectomy (total, or subtotal)
- Subject is pregnant or breast-feeding
- Prior noncompliance with previous study visit schedule and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.
Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
- Conditions
- Ulcerative Colitis
- Being tested
- Basiliximab
- Keywords
- 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.
BasiliximabDrug
Also called Simulect
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of basiliximab in subjects with ulcerative colitis
Measured: 1 year
Secondary outcomes (1)
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: lack of efficacy
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaily J. Reichert, Study director, Cerimon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061996
- Sponsor's protocol ID
- BSX-002
- Status last verified
- Feb 2010
- First submitted
- 2 Feb 2010
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01061996
- Acronym / sponsor ID
- BSX-002
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2010 (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.
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.
Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Basiliximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously met eligibility criteria in the previous basiliximab UC study
- Must have a total Mayo score at entry consistent with clinical response or clinical remission.
- Signed a current IRB/IEC-approved informed consent form
- Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
Key exclusion criteria (8 listed)
- Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
- Subject is currently receiving a restricted/prohibited concomitant medication
- Subject has undergone colectomy (total, or subtotal)
- Subject is pregnant or breast-feeding
- Prior noncompliance with previous study visit schedule and requirements
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 |
|---|---|---|
| BasiliximabAlso: SimulectStudy Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary. | Drug | 1 |
Primary outcome
Assess the safety of basiliximab in subjects with ulcerative colitis
Time frame: 1 year
1 secondary outcome
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
Related trials for Ulcerative Colitis
RecruitingPhase 2
A Study of AC-101 Tablets in Patients With Ulcerative Colitis
Ulcerative Colitis (UC)
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Not yet recruitingPhase 1
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis, Crohn's Disease
Recruiting
Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
Crohn Disease and Ulcerative Colitis
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.
Shaily J. Reichert study director
Cerimon Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basiliximab in people with Ulcerative Colitis, run by Cerimon Pharmaceuticals at 1 site in United Kingdom.
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 5 inclusion and 8 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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: lack of 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.
What does the primary outcome measure?
Assess the safety of basiliximab in subjects with ulcerative colitis (time frame: 1 year). 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 4 Feb 2010.