Immune System DiseasesPhase 1NCT01093911
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing CDP7657 in people with Immune System Diseases and Autoimmune Diseases, run by UCB Pharma at 8 sites in 3 countries.
Trial summary
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic
- What is being tested?
- CDP7657
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers and subjects with SLE
Who cannot join
- Severe neuropsychiatric or severe renal SLE
- History of chronic, recurrent, or recent severe infection
- Significant hematologic abnormalities
- History of cancer, heart failure, renal disease, liver disease or other serious illness
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
- Conditions
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Disease
- Being tested
- CDP7657, Placebo
- Keywords
- Lupus, SLE
- Medical subject headings
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP7657Biological
Ascending single doses of CDP7657
PlaceboOther
Placebo: 0.9% sodium chloride aqueous solution
| Study group | Role | What they receive |
|---|---|---|
| CDP7657 | Experimental | CDP7657 in dose escalating cohorts Receives: Biological: CDP7657 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
Measured: Day 0 to 119
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
Measured: Day 0 to 119
Time corresponding to Cmax (Tmax)
Measured: Day 0 to 119
Terminal elimination half-life (t 1/2)
Measured: Day 0 to 119
Plasma levels of anti-CDP7657 antibodies
Measured: Day 0 to 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
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 Immune System DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093911
- Sponsor's protocol ID
- SL0013
- Other IDs
- 2009-013617-10, 2009
- Status last verified
- Jan 2013
- First submitted
- 12 Mar 2010
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16.
PubMed 25784719
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.
- ClinicalTrials.gov ID
- NCT01093911
- Acronym / sponsor ID
- SL0013
- Conditions
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Disease
- Keywords
- Lupus, SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Mar 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.
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDP7657 | Experimental | Biological: CDP7657CDP7657 in dose escalating cohorts |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Volunteers and subjects with SLE
Key exclusion criteria (4 listed)
- Severe neuropsychiatric or severe renal SLE
- History of chronic, recurrent, or recent severe infection
- Significant hematologic abnormalities
- History of cancer, heart failure, renal disease, liver disease or other serious illness
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 |
|---|---|---|
| CDP7657Ascending single doses of CDP7657 | Biological | CDP7657 |
| PlaceboPlacebo: 0.9% sodium chloride aqueous solution | Other | Placebo |
Primary outcome
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
Time frame: Day 0 to 119
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day 0 to 119
Time corresponding to Cmax (Tmax)
Time frame: Day 0 to 119
Terminal elimination half-life (t 1/2)
Time frame: Day 0 to 119
Plasma levels of anti-CDP7657 antibodies
Time frame: Day 0 to 119
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 4 Jan 2013.
- Derived from this study: PubMed 25784719Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16.
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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)
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDP7657 in people with Immune System Diseases and Autoimmune Diseases, run by UCB Pharma at 8 sites in 3 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 1 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium, Bulgaria. 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 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.
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?
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting (time frame: Day 0 to 119). 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 NCT01093911, 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 4 Jan 2013.