On Open-Label Study in Participants With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)

Conditions
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Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Intervention / Treatment
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* Drug: LY2127399
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY 2127399 Q2W<br>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. | Drug: LY2127399<br>* 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.<br>Drug: Placebo<br>* Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.<br>|
| Experimental: LY2127399 Q4W<br>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. | Drug: LY2127399<br>* 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.<br>Drug: Placebo<br>* Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in SLE Disease Activity Index |  | Baseline, 4 years | 
| Occurrence of New Severe SLE Flares |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Lupus, Systemic Lupus Erythematosus, Immune System Disease