Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

July 14, 2015 updated by: UCB Pharma

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

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • 102
      • Leuven, Belgium
        • 101
  • Bulgaria
      • Plovidv, Bulgaria
        • 203
      • Sofia, Bulgaria
        • 202
      • Sofia, Bulgaria
        • 201
  • Germany
      • Berlin, Germany
        • 301
      • Erlangen, Germany
        • 303
      • Frankfurt, Germany
        • 305
      • Greifswald, Germany
        • 306
      • Hannover, Germany
        • 304
      • Kiel, Germany
        • 302
  • Poland
      • Krakow, Poland
        • 501
      • Wroclaw, Poland
        • 503
  • Romania
      • Bucharest, Romania
        • 601
      • Cluj, Romania
        • 602
  • Russian Federation
      • Moscow, Russian Federation
        • 701
      • Yaroslavl, Russian Federation
        • 702
  • Spain
      • Hospitalet Del Llobregat, Spain
        • 401
      • Santiago de Compostela, Spain
        • 402
      • Sevilla, Spain
        • 404
      • Sevilla, Spain
        • 405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo comparator
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
Time Frame: 0 - 28 Weeks
0 - 28 Weeks
Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
Time Frame: 0 - 28 Weeks
0 - 28 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: 0 - 28 Weeks
0 - 28 Weeks
Predose plasma concentration (Ctrough)
Time Frame: 0 - 28 Weeks
0 - 28 Weeks
Area under the concentration-time curve over the dosing interval (AUCτ)
Time Frame: 0 - 28 Weeks
0 - 28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Collaborators

Biogen

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL0014
  • 2012-000631-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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