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Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01764594
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date July 16, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
Incidence of Treatment-emergent Adervse Events (TEAE) in order to assess safety and tolerability of CDP7657 [ Time Frame: 0 to 12 Weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • Maximum plasma concentration (Cmax) [ Time Frame: 0 - 12 Weeks ]
  • Predose plasma concentration (Ctrough) [ Time Frame: 0 - 12 Weeks ]
  • Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Official Title  ICMJE 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
Brief Summary To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Condition  ICMJE
  • Immune System Diseases
  • Autoimmune Diseases
  • Lupus Erythematosus, Systemic
  • Skin and Connective Tissue Diseases
  • Connective Tissue Disease
Intervention  ICMJE
  • Biological: CDP7657

    CDP7657 100 mg/ ml solution

    30 mg/ kg initial dose

    15 mg/ kg every other week

    10 weeks

  • Other: Placebo
    Placebo comparator
Study Arms  ICMJE
  • Experimental: CDP7657

    CDP7657 100 mg/ ml solution

    30 mg/ kg initial dose

    15 mg/ kg every other week

    10 weeks

    Intervention: Biological: CDP7657
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Germany,   Poland,   Romania,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01764594
Other Study ID Numbers  ICMJE SL0014
2012-000631-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Biogen
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
PRS Account UCB Pharma
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP