Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Autoimmune Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764594
• Other study ID #: SL0014
• Secondary ID: 2012-000631-11
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2013
• Last updated: July 14, 2015
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Placebo
Placebo comparator

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	Biogen

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Germany,  Poland,  Romania,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study		0 - 28 Weeks	No
Primary	Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study		0 - 28 Weeks	No
Secondary	Maximum plasma concentration (Cmax)		0 - 28 Weeks	No
Secondary	Predose plasma concentration (Ctrough)		0 - 28 Weeks	No
Secondary	Area under the concentration-time curve over the dosing interval (AUCt)		0 - 28 Weeks	No