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OpenTrials
Completed

NCT Number: NCT01764594

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

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Key information

Conditions

Immune System Diseases Autoimmune Diseases Connective Tissue Disease Connective Tissue Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

102, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDP7657

Biological

CDP7657 100 mg/ ml solution

30 mg/ kg initial dose

15 mg/ kg every other week

10 weeks

Placebo

Other

Placebo comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • Biogen

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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