Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01764594

Collaborator

Biogen (Industry)

Enrollment

Locations

Arms

Duration (Months)

1.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Condition or Disease	Intervention/Treatment	Phase
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease	Biological: CDP7657 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDP7657 CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks	Biological: CDP7657 CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks
Placebo Comparator: Placebo Placebo	Other: Placebo Placebo comparator

Arm

Intervention/Treatment

Experimental: CDP7657

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

Biological: CDP7657

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

Placebo Comparator: Placebo

Placebo

Other: Placebo

Placebo comparator

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	102	Brussels	Belgium
2	101	Leuven	Belgium
3	203	Plovidv	Bulgaria
4	201	Sofia	Bulgaria
5	202	Sofia	Bulgaria
6	301	Berlin	Germany
7	303	Erlangen	Germany
8	305	Frankfurt	Germany
9	306	Greifswald	Germany
10	304	Hannover	Germany
11	302	Kiel	Germany
12	501	Krakow	Poland
13	503	Wroclaw	Poland
14	601	Bucharest	Romania
15	602	Cluj	Romania
16	701	Moscow	Russian Federation
17	702	Yaroslavl	Russian Federation
18	401	Hospitalet Del Llobregat	Spain
19	402	Santiago de Compostela	Spain
20	404	Sevilla	Spain
21	405	Sevilla	Spain