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

Primary Purpose

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

LY2127399

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, SLE, Systemic Lupus Erythematosus, Immune System Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LY 2127399 Q2W

LY2127399 Q4W

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response

Proportion of Participants With a Reduction in Steroid Dose

Change in SLE Disease Activity Index

Occurrence of New Severe SLE Flares

Proportion of Participants With Improvement in Lupus Quality of Life

Change in Anti-double-stranded Deoxyribonucleic Acid Level

Full Information

NCT ID

NCT01488708

First Posted

December 6, 2011

Last Updated

May 16, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01488708

Brief Title

On Open-Label Study in Participants With Systemic Lupus Erythematosus

Acronym

Illuminate-X

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy

Study Start Date

January 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Keywords

Lupus, SLE, Systemic Lupus Erythematosus, Immune System Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1518 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY 2127399 Q2W

Arm Type

Experimental

Arm Description

Arm Title

LY2127399 Q4W

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LY2127399

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Primary Outcome Measure Information:

Title

Percentage of Participants With Adverse Events (AEs)

Description

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Time Frame

Baseline through 4 years

Secondary Outcome Measure Information:

Title

Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response

Time Frame

Week 48

Title

Proportion of Participants With a Reduction in Steroid Dose

Time Frame

Baseline through 4 years

Title

Change in SLE Disease Activity Index

Time Frame

Baseline, 4 years

Title

Occurrence of New Severe SLE Flares

Time Frame

Baseline through 4 years

Title

Proportion of Participants With Improvement in Lupus Quality of Life

Time Frame

4 years

Title

Change in Anti-double-stranded Deoxyribonucleic Acid Level

Time Frame

Baseline, 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Irving

State/Province

Texas

ZIP/Postal Code

75061

Country

United States

12. IPD Sharing Statement

Learn more about this trial

On Open-Label Study in Participants With Systemic Lupus Erythematosus

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