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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:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

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
Belgium
102
Brussels, Belgium
101
Leuven, Belgium
Bulgaria
203
Plovidv, Bulgaria
201
Sofia, Bulgaria
202
Sofia, Bulgaria
Germany
301
Berlin, Germany
303
Erlangen, Germany
305
Frankfurt, Germany
306
Greifswald, Germany
304
Hannover, Germany
302
Kiel, Germany
Poland
501
Krakow, Poland
503
Wroclaw, Poland
Romania
601
Bucharest, Romania
602
Cluj, Romania
Russian Federation
701
Moscow, Russian Federation
702
Yaroslavl, Russian Federation
Spain
401
Hospitalet Del Llobregat, Spain
402
Santiago de Compostela, Spain
404
Sevilla, Spain
405
Sevilla, Spain
Sponsors and Collaborators
UCB Pharma
Biogen
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01764594     History of Changes
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:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs