Immune System DiseasesPhase 1NCT01764594
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
A Phase 1 study testing CDP7657 in people with Immune System Diseases and Autoimmune Diseases, run by UCB Pharma at 21 sites in 7 countries.
Trial summary
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 24 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Jan 2013to Aug 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Systemic Lupus Erythematosus (SLE)
Who cannot join
- Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (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
21 sites in 7 countries.
21 sites in 7 countries
Germany6 sites
301
Berlin
303
Erlangen
305
Frankfurt
306
Greifswald
304
Hanover
302
Kiel
Spain4 sites
401
Hospitalet Del Llobregat
402
Santiago de Compostela
404
Seville
405
Seville
About this study
Official title: A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus
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
CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| CDP7657 | Experimental | CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks Receives: Biological: CDP7657 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
Measured: 0 - 28 Weeks
Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
Measured: 0 - 28 Weeks
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
Measured: 0 - 28 Weeks
Predose plasma concentration (Ctrough)
Measured: 0 - 28 Weeks
Area under the concentration-time curve over the dosing interval (AUCτ)
Measured: 0 - 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764594
- Sponsor's protocol ID
- SL0014
- Other IDs
- 2012-000631-11
- Status last verified
- Jul 2015
- First submitted
- 2 Jan 2013
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chamberlain C, Colman PJ, Ranger AM, Burkly LC, Johnston GI, Otoul C, Stach C, Zamacona M, Dorner T, Urowitz M, Hiepe F. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann Rheum Dis. 2017 Nov;76(11):1837-1844. doi: 10.1136/annrheumdis-2017-211388. Epub 2017 Aug 5.
PubMed 28780512
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01764594
- Acronym / sponsor ID
- SL0014
- 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
- 24 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Jan 2013 (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
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDP7657 | Experimental | Biological: CDP7657CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Systemic Lupus Erythematosus (SLE)
Key exclusion criteria (4 listed)
- Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (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 |
|---|---|---|
| CDP7657CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks | Biological | CDP7657 |
| PlaceboPlacebo comparator | Other | Placebo |
Primary outcome
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
Time frame: 0 - 28 Weeks
Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
Time frame: 0 - 28 Weeks
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 0 - 28 Weeks
Predose plasma concentration (Ctrough)
Time frame: 0 - 28 Weeks
Area under the concentration-time curve over the dosing interval (AUCτ)
Time frame: 0 - 28 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 16 Jul 2015.
- Derived from this study: PubMed 28780512Chamberlain C, Colman PJ, Ranger AM, Burkly LC, Johnston GI, Otoul C, Stach C, Zamacona M, Dorner T, Urowitz M, Hiepe F. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann Rheum Dis. 2017 Nov;76(11):1837-1844. doi: 10.1136/annrheumdis-2017-211388. Epub 2017 Aug 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
+1 877 822 9493
21 sites in 7 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 21 sites in 7 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 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Spain, Bulgaria, Belgium, Poland and 2 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 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?
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study (time frame: 0 - 28 Weeks). The study lists 2 primary outcomes in all. 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 NCT01764594, 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 16 Jul 2015.