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Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

NCT01764594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-16

No results posted yet for this study

Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Conditions

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

Interventions

BIOLOGICAL

CDP7657

CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks

OTHER

Placebo

Placebo comparator

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Belgium
  • Bulgaria
  • Germany
  • Poland
  • Romania
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764594 on ClinicalTrials.gov