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Trial record 5 of 7 for:    Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | First posted from 01/01/2013 to 04/16/2013
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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

Study Description
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Brief Summary:
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Condition or disease Intervention/treatment Phase
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease Biological: CDP7657 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: CDP7657

CDP7657 100 mg/ ml solution

30 mg/ kg initial dose

15 mg/ kg every other week

10 weeks

 Biological: CDP7657

CDP7657 100 mg/ ml solution

30 mg/ kg initial dose

15 mg/ kg every other week

10 weeks
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ]
  2. Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 0 - 28 Weeks ]
  2. Predose plasma concentration (Ctrough) [ Time Frame: 0 - 28 Weeks ]
  3. Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 28 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764594


Locations
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Sponsors and Collaborators
UCB Pharma
Biogen
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493
More Information
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01764594    
Other Study ID Numbers: SL0014
2012-000631-11 ( EudraCT Number )
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Keywords provided by UCB Pharma:
Lupus
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases