On Open-Label Study in Participants With Systemic Lupus Erythematosus

Phase 3

Terminated

• Conditions: Autoimmune Disease; Connective Tissue Disease; Systemic Lupus Erythematosus
• Interventions: Drug: LY2127399; Drug: Placebo

• Registration Number: NCT01488708
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Disposition First Submitted: 2016-03-10
• Disposition First Submitted QC: 2016-03-10
• Disposition First Posted: 2016-03-24
• Results First Submitted: 2018-03-24
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-16
• Last Update Submitted: 2018-05-16
• Results First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1518

Inclusion Criteria

• Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
• Given written informed consent
• Test negative for pregnancy at the time of enrollment
• Agree to use a reliable method of birth control

Exclusion Criteria

• Unwilling to comply with study procedures
• Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
• Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY 2127399 Q2W	Placebo	If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.
LY2127399 Q4W	Placebo	If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.
LY 2127399 Q2W	LY2127399	If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.
LY2127399 Q4W	LY2127399	If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Baseline through 4 years	A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary Outcome Measures

Name	Time	Method
Change in SLE Disease Activity Index	Baseline, 4 years
Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response	Week 48
Proportion of Participants With a Reduction in Steroid Dose	Baseline through 4 years
Proportion of Participants With Improvement in Lupus Quality of Life	4 years
Change in Anti-double-stranded Deoxyribonucleic Acid Level	Baseline, 4 years
Occurrence of New Severe SLE Flares	Baseline through 4 years

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician; 🇺🇸 Irving, Texas, United States