Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified April 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: April 24, 2013
Last verified: April 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:
- Incidence of Treatment-emergent Adervse Events (TEAE) in order to assess safety and tolerability of CDP7657 [ Time Frame: 0 to 12 Weeks ] [ Designated as safety issue: No ]To assess the frequency and severity of TEAEs in patients receiving CDP7657 compared to those receiving placebo. This will include documentation of TEAE type, duration, causality, severity, outcome, action required and withdrawal rates.
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 | |
| 101 | Recruiting |
| Leuven, Belgium | |
| Bulgaria | |
| 201 | Recruiting |
| Sofia, Bulgaria | |
| 202 | Recruiting |
| Sofia, Bulgaria | |
| Germany | |
| 301 | Recruiting |
| Berlin, Germany | |
| 303 | Recruiting |
| Erlangen, Germany | |
| 302 | Recruiting |
| Kiel, Germany | |
| Spain | |
| 401 | Recruiting |
| Hospitalet Del Llobregat, Spain | |
| 404 | 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: | April 24, 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 May 23, 2013