Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified June 2013 by UCB, Inc.
Sponsor:
UCB, Inc.
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01764594
First received: January 2, 2013
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
| Condition | Intervention | Phase |
|---|---|---|
|
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease |
Biological: CDP7657 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
| 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 |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
- Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximum plasma concentration (Cmax) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
- Predose plasma concentration (Ctrough) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
- Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 12 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CDP7657
CDP7657 100 mg/ml solution 60 mg/kg initial dose 30 mg/kg every other week 10 weeks
|
Biological: CDP7657
CDP7657 100 mg/ml solution 60 mg/kg initial dose 30 mg/kg every other week 10 weeks
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Placebo comparator
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with Systemic Lupus Erythematosus (SLE)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764594
Contacts
| Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
Locations
| Belgium | |
| 102 | Recruiting |
| Brussels, Belgium | |
| 101 | Recruiting |
| Leuven, Belgium | |
| Bulgaria | |
| 201 | Recruiting |
| Sofia, Bulgaria | |
| 202 | Recruiting |
| Sofia, Bulgaria | |
| Germany | |
| 301 | Recruiting |
| Berlin, Germany | |
| 303 | Recruiting |
| Erlangen, Germany | |
| 305 | Recruiting |
| Frankfurt, Germany | |
| 302 | Recruiting |
| Kiel, Germany | |
| Romania | |
| 601 | Recruiting |
| Bucharest, Romania | |
| 602 | Recruiting |
| Cluj, Romania | |
| Spain | |
| 401 | Recruiting |
| Hospitalet Del Llobregat, Spain | |
| 402 | Recruiting |
| Santiago de Compostela, Spain | |
| 404 | Recruiting |
| Sevilla, Spain | |
| 405 | Recruiting |
| Sevilla, Spain | |
Sponsors and Collaborators
UCB, Inc.
Biogen Idec
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01764594 History of Changes |
| Other Study ID Numbers: | SL0014, 2012-000631-11 |
| Study First Received: | January 2, 2013 |
| Last Updated: | June 4, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Russia: Ministry of Health of the Russian Federation |
Keywords provided by UCB, Inc.:
|
Lupus SLE |
Additional relevant MeSH terms:
|
Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic |
ClinicalTrials.gov processed this record on June 17, 2013