Relapsing Multiple SclerosisPhase 1/2NCT00726648
CDP323 Biomarker Study
A Phase 1/2 study testing CDP323 in people with Relapsing Multiple Sclerosis, run by UCB Pharma at 2 sites in United Kingdom.
Trial summary
Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing 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
- 71 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects aged 18-65 years
- Relapsing form of MS with at least one clinical relapse in the 24 months before screening;
- Screening EDSS score of 0-6.5;
- Must be fully immunocompetent
- Female subjects of childbearing potential must agree to practice contraception methods
Who cannot join
- Any conditions that could interfere with the contrast-enhanced MRI;
- Any clinically significant disease state or findings other than MS;
- Any clinically significant deviation from the pre-defined ranges for laboratory tests;
- Concomitant treatment with MS disease modifying drugs
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
Croydon, Surrey
Study site
Tooting, London
About this study
Official title: Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.
Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- CDP323, Placebo
- Keywords
- CDP323, Relapsing multiple sclerosis, Blood biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP323Drug
50mg capsules, 100mg bid for 4 weeks
CDP323Drug
250mg capsules, 500mg bid for 4 weeks
CDP323Drug
250mg capsules, 1000mg bid for 4 weeks
CDP323Drug
250mg capsules, 1000mg daily for 4 weeks
PlaceboDrug
placebo capsules for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CDP323; Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: CDP323; Drug: Placebo |
| 3 | Experimental | Not described Receives: Drug: CDP323; Drug: Placebo |
| 4 | Experimental | Not described Receives: Drug: CDP323; Drug: Placebo |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic parameters related to leukocyte trafficking
Measured: 4 weeks
Secondary outcomes (2)
Standard and disease-related safety variables
Measured: 4 weeks
Class-related safety parameters
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Relapsing 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 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, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726648
- Sponsor's protocol ID
- C32325
- Other IDs
- EudraCT 2008-000147-34, IND 74863
- Status last verified
- Aug 2009
- First submitted
- 29 Jul 2008
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolf C, Sidhu J, Otoul C, Morris DL, Cnops J, Taubel J, Bennett B. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study. PLoS One. 2013;8(3):e58438. doi: 10.1371/journal.pone.0058438. Epub 2013 Mar 5.
PubMed 23472197
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 Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.
- ClinicalTrials.gov ID
- NCT00726648
- Acronym / sponsor ID
- C32325
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- CDP323, Relapsing multiple sclerosis, Blood biomarkers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Aug 2008 (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.
Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CDP323, Drug: Placebo |
| 2 | Experimental | Drug: CDP323, Drug: Placebo |
| 3 | Experimental | Drug: CDP323, Drug: Placebo |
| 4 | Experimental | Drug: CDP323, Drug: Placebo |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male subjects aged 18-65 years
- Relapsing form of MS with at least one clinical relapse in the 24 months before screening;
- Screening EDSS score of 0-6.5;
- Must be fully immunocompetent
- Female subjects of childbearing potential must agree to practice contraception methods
Key exclusion criteria (4 listed)
- Any conditions that could interfere with the contrast-enhanced MRI;
- Any clinically significant disease state or findings other than MS;
- Any clinically significant deviation from the pre-defined ranges for laboratory tests;
- Concomitant treatment with MS disease modifying drugs
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 |
|---|---|---|
| CDP32350mg capsules, 100mg bid for 4 weeks | Drug | 2 |
| CDP323250mg capsules, 500mg bid for 4 weeks | Drug | 3 |
| CDP323250mg capsules, 1000mg bid for 4 weeks | Drug | 4 |
| CDP323250mg capsules, 1000mg daily for 4 weeks | Drug | 1 |
| Placeboplacebo capsules for 4 weeks | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Pharmacodynamic parameters related to leukocyte trafficking
Time frame: 4 weeks
2 secondary outcomes
Standard and disease-related safety variables
Time frame: 4 weeks
Class-related safety parameters
Time frame: 4 weeks
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 12 Sep 2011.
- Derived from this study: PubMed 23472197Wolf C, Sidhu J, Otoul C, Morris DL, Cnops J, Taubel J, Bennett B. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study. PLoS One. 2013;8(3):e58438. doi: 10.1371/journal.pone.0058438. Epub 2013 Mar 5.
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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
UCB Pharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CDP323 in people with Relapsing Multiple Sclerosis, run by UCB Pharma at 2 sites 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 4 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 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 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacodynamic parameters related to leukocyte trafficking (time frame: 4 weeks). 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 NCT00726648, 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 Sep 2011.