Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Phase 1
Completed
- Conditions
- Immune System DiseasesAutoimmune DiseasesConnective Tissue DiseaseLupus Erythematosus, SystemicSkin and Connective Tissue Diseases
- Registration Number
- NCT01764594
- Lead Sponsor
- UCB Pharma
- Brief Summary
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study 0 - 28 Weeks Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study 0 - 28 Weeks
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) 0 - 28 Weeks Predose plasma concentration (Ctrough) 0 - 28 Weeks Area under the concentration-time curve over the dosing interval (AUCτ) 0 - 28 Weeks
Trial Locations
- Locations (21)
102
🇧🇪Brussels, Belgium
101
🇧🇪Leuven, Belgium
203
🇧🇬Plovidv, Bulgaria
201
🇧🇬Sofia, Bulgaria
202
🇧🇬Sofia, Bulgaria
301
🇩🇪Berlin, Germany
303
🇩🇪Erlangen, Germany
305
🇩🇪Frankfurt, Germany
306
🇩🇪Greifswald, Germany
304
🇩🇪Hannover, Germany
Scroll for more (11 remaining)102🇧🇪Brussels, Belgium