Multiple SclerosisPhase 2NCT00484536
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
A Phase 2 study testing CDP323 in people with Multiple Sclerosis, run by UCB Pharma at 71 sites in 11 countries.
Trial summary
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- CDP323
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 71 sitesin 11 countries
- Study dates
- May 2007to Jul 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsing form of MS
- screening EDSS score 0 - 5.5, inclusive
- at least one clinical relapse in the 12 months before screening
- active disease, defined by set of MRI activity criteria
- failed prior treatment with beta-interferons or glatiramer acetate
Who cannot join
- signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
- known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
- pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
Trial locations and contacts
71 sites in 11 countries.
71 sites in 11 countries
United States22 sites
Study site
Atlanta, Georgia
Study site
Charleston, West Virginia
Study site
Charlotte, North Carolina
Study site
Columbus, Ohio
Study site
Cullman, Alabama
Study site
Dallas, Texas
Study site
Farmington Hills, Michigan
Study site
Fort Wayne, Indiana
Study site
Kansas City, Kansas
Study site
Kirkland, Washington
Study site
Lenexa, Kansas
Study site
Lexington, Kentucky
Study site
Louisville, Kentucky
Study site
Maitland, Florida
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
Northbrook, Illinois
Study site
Phoenix, Arizona
Study site
Providence, Rhode Island
Study site
Springs, Colorado
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia
Germany8 sites
Study site
Bayreuth
Study site
Berlin
Study site
Giessen
Study site
Hamburg
Study site
Marburg
Study site
Rostock
Study site
Ulm
Study site
Wiesbaden
Spain8 sites
Study site
Barcelona
Study site
Bilbao
Study site
Girona
Study site
Madrid
Study site
Málaga
Study site
Oviedo
Study site
Santa Cruz de Tenerife
Study site
Seville
Belgium6 sites
Study site
Diepenbeek
Study site
Ghent
Study site
Melsbroek
Study site
Overpelt
Study site
Sijsele
Study site
Sint-Truiden
Canada5 sites
Study site
Gatineau, Quebec
Study site
Greenfield Park, Quebec
Study site
London, Ontario
Study site
Ottawa, Ontario
Study site
Sherbrooke, Quebec
France5 sites
Study site
Besançon
Study site
Clermont-Ferrand
Study site
Lyon
Study site
Rennes
Study site
Strasbourg
Hungary4 sites
Study site
Budapest
Study site
Győr
Study site
Nyíregyháza
Study site
Pécs
Netherlands4 sites
Study site
Amsterdam
Study site
Breda
Study site
Nieuwegein
Study site
Nijmegen
United Kingdom4 sites
Study site
Hartshill
Study site
Newcastle
Study site
Nottingham
Study site
Sheffield
About this study
Official title: Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
- Conditions
- Multiple Sclerosis
- Being tested
- CDP323, placebo
- Keywords
- CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, Oral Compound, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP323Drug
250 mg capsules, 500 mg bid (1000 mg/day)
placeboDrug
capsules, once daily
CDP323Drug
250 mg Capsules, 500 mg, once daily
| Study group | Role | What they receive |
|---|---|---|
| CDP323 1000 mg/day | Experimental | Not described Receives: Drug: CDP323 |
| CDP323 500 mg/day | Experimental | Not described Receives: Drug: CDP323 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.
Measured: Cumulative number of newly active lesions from baseline to Week 28.
Secondary outcomes (1)
Occurrence of any treatment emergent adverse event.
Measured: During up to 24 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionJul 2010
Why it stopped: The study was discontinued due to unfavorable interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484536
- Sponsor's protocol ID
- C32322
- Other IDs
- 2006-002204-33
- Status last verified
- Mar 2011
- First submitted
- 8 Jun 2007
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
- ClinicalTrials.gov ID
- NCT00484536
- Acronym / sponsor ID
- C32322
- Conditions
- Multiple Sclerosis
- Keywords
- CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, Oral Compound, MS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to unfavorable interim analysis
- Enrolment
- 232 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Jun 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 objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDP323 1000 mg/day | Experimental | Drug: CDP323 |
| CDP323 500 mg/day | Experimental | Drug: CDP323 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- relapsing form of MS
- screening EDSS score 0 - 5.5, inclusive
- at least one clinical relapse in the 12 months before screening
- active disease, defined by set of MRI activity criteria
- failed prior treatment with beta-interferons or glatiramer acetate
Key exclusion criteria (3 listed)
- signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
- known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
- pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
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 |
|---|---|---|
| CDP323250 mg capsules, 500 mg bid (1000 mg/day) | Drug | CDP323 1000 mg/day |
| placebocapsules, once daily | Drug | Placebo |
| CDP323250 mg Capsules, 500 mg, once daily | Drug | CDP323 500 mg/day |
Primary outcome
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
Time frame: Cumulative number of newly active lesions from baseline to Week 28.
The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.
1 secondary outcome
Occurrence of any treatment emergent adverse event.
Time frame: During up to 24 weeks of treatment.
Results and safety
The study was stopped early (reason given: The study was discontinued due to unfavorable interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2011.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
71 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDP323 in people with Multiple Sclerosis, run by UCB Pharma at 71 sites in 11 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 5 inclusion and 3 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 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Germany, Spain, Belgium, Canada and 6 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 was stopped early (reason given: The study was discontinued due to unfavorable interim analysis). 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?
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28). (time frame: Cumulative number of newly active lesions from baseline to Week 28.). 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 12 Sep 2011.