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CompletedNCT01093911Updated Jan 4, 2013

Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

A Phase 1 interventional study of CDP7657 and Placebo in Immune System Diseases, Autoimmune Diseases and Lupus Erythematosus, Systemic, sponsored by UCB Pharma. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-04.

Sponsored by UCB Pharma · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

02

Conditions studied

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

Keywords

  • Lupus
  • SLE
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Volunteers and subjects with SLE

Exclusion criteria

Exclusion Criteria:

  • Severe neuropsychiatric or severe renal 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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    CDP7657

    CDP7657 in dose escalating cohorts

    Biological: CDP7657

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • BiologicalCDP7657

    Ascending single doses of CDP7657

  • OtherPlacebo

    Placebo: 0.9% sodium chloride aqueous solution

06

What researchers measure

Primary outcomes

  1. Assessment of safety of CDP7657 as per Adverse Event (AE) reporting

    Time frame: Day 0 to 119

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Day 0 to 119

  2. Time corresponding to Cmax (Tmax)

    Time frame: Day 0 to 119

  3. Terminal elimination half-life (t 1/2)

    Time frame: Day 0 to 119

  4. Plasma levels of anti-CDP7657 antibodies

    Time frame: Day 0 to 119

07

Study locations

8 sites
  • 6
    Leuven, Belgium
  • 9
    Sofia, Bulgaria
  • 1
    Berlin, Germany
  • 2
    Erlangen, Germany
  • 3
    Frankfurt, Germany
  • 4
    Hannover, Germany
  • 8
    Kiel, Germany
  • 7
    Münster, Germany
08

References and documents

Publications

  • Tocoian A, Buchan P, Kirby H, Soranson J, Zamacona M, Walley R, Mitchell N, Esfandiari E, Wagner F, Oliver R. First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. Lupus. 2015 Sep;24(10):1045-56. doi: 10.1177/0961203315574558. Epub 2015 Mar 16. PubMed 25784719 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01093911
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Mar 26, 2010
Start date
Mar 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jan 4, 2013

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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