Safety Study of CDP7657 in Patients With Systemic Lupus E... | NCT01764594 | Trialant

Safety Study of CDP7657 in Patients With Systemic Lupus E... | NCT01764594 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28780512	Derived	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.