Ulcerative ColitisPhase 2NCT00430898
Basiliximab in Moderate to Severe Ulcerative Colitis
A Phase 2 study testing Basiliximab in people with Ulcerative Colitis, run by Cerimon Pharmaceuticals at 68 sites in 9 countries.
Trial summary
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo. 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 68 sitesin 9 countries
- Study dates
- Jan 2007to Sep 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
- In addition to others,
- Men or women age 18-75
- Diagnosis of ulcerative colitis confirmed through screening endoscopy.
- Extent of disease must involve at least the left colon
- Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
- Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry
Who cannot join
- In addition to other protocol-defined conditions,
- Pregnancy
- Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
- Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
- Severely ill patients as evidenced by protocol-defined systemic criteria
- Chest radiograph abnormalities consistent with an infectious process
Show all 10Show fewer
- History of colonic dysplasia
- HIV infection
- Known viral Hepatitis B or C infection
- History of or exposure to tuberculosis within 6 months before study entry
Trial locations and contacts
68 sites in 9 countries.
68 sites in 9 countries
United States25 sites
Study site
Anaheim, California
Study site
Atlanta, Georgia
Study site
Boston, Massachusetts, 02114
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44195
Study site
Egg Harbor Twp, New Jersey, 08234
Study site
Fargo, North Dakota, 58104
Study site
Fort Worth, Texas, 76104
Study site
Galveston, Texas
Study site
Germantown, Tennessee
Study site
Golden, Colorado
Study site
Great Neck, New York
Study site
Hollywood, Florida
Study site
Houston, Texas, 77090
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky, 40536
Study site
Littleton, Colorado
Study site
New York, New York
Study site
Roseville, California, 95661
Study site
Sewickley, Pennsylvania, 15143
Study site
Topeka, Kansas, 66606
Study site
Troy, Michigan
Study site
Urbana, Illinois, 61801
Study site
Winter Park, Florida, 32789
India9 sites
Study site
Bangalore, 560 054
Study site
Hyderabaad, 500012
Study site
Kochi, 682017
Study site
Kolkata, 700020
Study site
Lucknow, 226014
Study site
Ludhiana, 141001
Study site
Mumbai, 400016
Study site
New Delhi, 110076
Study site
Visakhapatnam, 530 002
Poland8 sites
Study site
Gdansk
Study site
Krakow, 31-826
Study site
Krakow
Study site
Poznan, 60-353
Study site
Sopot, 81-756
Study site
Sopot, 81-820
Study site
Warsaw, 02-098
Study site
Wroclaw, 54-144
Czechia6 sites
Study site
Mladá Boleslav, 293 50
Study site
Prague, 100 34
Study site
Prague, 170 00
Study site
Prague
Study site
Tábor, 390 03
Study site
Ústí nad Orlicí, 562 18
Slovakia5 sites
Study site
Bratislava, 811 07
Study site
Bratislava, 851 01
Study site
Nitra, 949 01
Study site
Nové Mesto nad Váhom, 915 01
Study site
Prešov, 080 01
Ukraine5 sites
Study site
Dnipro, 49074
Study site
Ivano-Frankivsk, 76000
Study site
Kharkiv, 61037
Study site
Kyiv, 01021
Study site
Kyiv, 04210
United Kingdom5 sites
Study site
Bristol, BS2 8HW
Study site
Derbyshire, DE22 3NE
Study site
London, WC1E 6DB
Study site
Stoke-on-Trent, ST4 6QB
Study site
Wigan, WN1 2NN
Russia4 sites
Study site
Moscow, 115446
Study site
Moscow, 121309
Study site
Samara, 443011
Study site
Smolensk, 214001
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
- Conditions
- Ulcerative Colitis
- Being tested
- Basiliximab
- Keywords
- ulcerative colitis basiliximab
- 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
3 doses of 40mg, IV at baseline, week 2, and week 4
| Study group | Role | What they receive |
|---|---|---|
| 1. Placebo | Placebo comparator | Placebo to mimic 40 mg of Simulect Receives: Drug: Basiliximab |
| 2. 40 mg Simulect | Experimental | 40 mg of Simulect Receives: Drug: Basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo Score, Safety
Measured: At week 8
Secondary outcomes (1)
Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use
Measured: at week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Levitt, MD, PhD, Study director, Cerimon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430898
- Sponsor's protocol ID
- BSX-001
- Status last verified
- Dec 2008
- First submitted
- 31 Jan 2007
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.
PubMed 22549092
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00430898
- Acronym / sponsor ID
- BSX-001
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis basiliximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Feb 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.
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Placebo | Placebo comparator | Drug: BasiliximabPlacebo to mimic 40 mg of Simulect |
| 2. 40 mg Simulect | Experimental | Drug: Basiliximab40 mg of Simulect |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In addition to others,
- Men or women age 18-75
- Diagnosis of ulcerative colitis confirmed through screening endoscopy.
- Extent of disease must involve at least the left colon
- Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
Key exclusion criteria (10 listed)
- In addition to other protocol-defined conditions,
- Pregnancy
- Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
- Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
- Severely ill patients as evidenced by protocol-defined systemic criteria
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: Simulect3 doses of 40mg, IV at baseline, week 2, and week 4 | Drug | 1. Placebo, 2. 40 mg Simulect |
Primary outcome
Change in Mayo Score, Safety
Time frame: At week 8
1 secondary outcome
Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use
Time frame: at week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
- Derived from this study: PubMed 22549092Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.
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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.
Daniel Levitt, MD, PhD study director
Cerimon Pharmaceuticals
68 sites in 9 countries: 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 68 sites in 9 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, India, Poland, Czechia, Slovakia and 4 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mayo Score, Safety (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430898, 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 18 Dec 2008.