Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01764594
First received: January 2, 2013
Last updated: June 26, 2014
Last verified: June 2014
  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:
  • Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Predose plasma concentration (Ctrough) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve over the dosing interval (AUCτ) [ Time Frame: 0 - 28 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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: June 26, 2014
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 July 28, 2014