On Open-Label Study in Participants With Systemic Lupus Erythematosus (Illuminate-X)

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)

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).

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus; Autoimmune Disease; Connective Tissue Disease
• Intervention / Treatment: Drug: LY2127399; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1518
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75061
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY 2127399 Q2W; 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; 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.; Drug: Placebo; Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Experimental: LY2127399 Q4W; 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; 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.; Drug: Placebo; Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST, Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Immune System Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases
• Other Study ID Numbers: 13811; H9B-MC-BCDX (Other Identifier: Eli Lilly and Company)