NCT01764594

Brief Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
7 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

January 2, 2013

Last Update Submit

July 14, 2015

Conditions

Immune System DiseasesAutoimmune DiseasesLupus Erythematosus, SystemicSkin and Connective Tissue DiseasesConnective Tissue Disease

Keywords

LupusSLE

Outcome Measures

Primary Outcomes (2)

  • Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study

    0 - 28 Weeks

  • Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study

    0 - 28 Weeks

Secondary Outcomes (3)

  • Maximum plasma concentration (Cmax)

    0 - 28 Weeks

  • Predose plasma concentration (Ctrough)

    0 - 28 Weeks

  • Area under the concentration-time curve over the dosing interval (AUCτ)

    0 - 28 Weeks

Study Arms (2)

CDP7657

EXPERIMENTAL

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

Biological: CDP7657

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CDP7657BIOLOGICAL

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

CDP7657
PlaceboOTHER

Placebo comparator

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Systemic Lupus Erythematosus (SLE)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

102

Brussels, Belgium

Location

101

Leuven, Belgium

Location

203

Plovidv, Bulgaria

Location

201

Sofia, Bulgaria

Location

202

Sofia, Bulgaria

Location

301

Berlin, Germany

Location

303

Erlangen, Germany

Location

305

Frankfurt, Germany

Location

306

Greifswald, Germany

Location

304

Hanover, Germany

Location

302

Kiel, Germany

Location

501

Krakow, Poland

Location

503

Wroclaw, Poland

Location

601

Bucharest, Romania

Location

602

Cluj-Napoca, Romania

Location

701

Moscow, Russia

Location

702

Yaroslavl, Russia

Location

401

Hospitalet Del Llobregat, Spain

Location

402

Santiago de Compostela, Spain

Location

404

Seville, Spain

Location

405

Seville, Spain

Location

Related Publications (1)

  • Chamberlain C, Colman PJ, Ranger AM, Burkly LC, Johnston GI, Otoul C, Stach C, Zamacona M, Dorner T, Urowitz M, Hiepe F. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann Rheum Dis. 2017 Nov;76(11):1837-1844. doi: 10.1136/annrheumdis-2017-211388. Epub 2017 Aug 5.

    PMID: 28780512DERIVED

MeSH Terms

Conditions

Immune System DiseasesAutoimmune DiseasesLupus Erythematosus, SystemicSkin and Connective Tissue DiseasesConnective Tissue Diseases

Interventions

dapirolizumab pegol

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 9, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

RO(2)RU(2)ES(4)BE(2)DE(6)BU(3)PL(2)