Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Phase 1

Completed

• Conditions: Immune System Diseases; Autoimmune Diseases; Connective Tissue Disease; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases
• Interventions: Other: Placebo; Biological: CDP7657

• Registration Number: NCT01764594
• Lead Sponsor: UCB Pharma

Brief Summary

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (21)

101; 🇧🇪 Leuven, Belgium

203; 🇧🇬 Plovidv, Bulgaria

201; 🇧🇬 Sofia, Bulgaria

202; 🇧🇬 Sofia, Bulgaria

301; 🇩🇪 Berlin, Germany

303; 🇩🇪 Erlangen, Germany

305; 🇩🇪 Frankfurt, Germany

306; 🇩🇪 Greifswald, Germany

304; 🇩🇪 Hannover, Germany

302; 🇩🇪 Kiel, Germany

501; 🇵🇱 Krakow, Poland

503; 🇵🇱 Wroclaw, Poland

602; 🇷🇴 Cluj, Romania

102; 🇧🇪 Brussels, Belgium

601; 🇷🇴 Bucharest, Romania

405; 🇪🇸 Sevilla, Spain

401; 🇪🇸 Hospitalet Del Llobregat, Spain

701; 🇷🇺 Moscow, Russian Federation

702; 🇷🇺 Yaroslavl, Russian Federation

402; 🇪🇸 Santiago de Compostela, Spain

404; 🇪🇸 Sevilla, Spain