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On Open-Label Study in Participants With Systemic Lupus Erythematosus

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)

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01488708
Acronym
Illuminate-X
Enrollment
1518
Registered
2011-12-08
Start date
2012-01-31
Completion date
2015-10-31
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease, Connective Tissue Disease, Systemic Lupus Erythematosus

Keywords

Lupus, SLE, Systemic Lupus Erythematosus, Immune System Disease

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).

Interventions

DRUGLY2127399

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.

DRUGPlacebo

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

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Adverse Events (AEs)Baseline through 4 yearsA summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary

MeasureTime frame
Proportion of Participants With a Reduction in Steroid DoseBaseline through 4 years
Change in SLE Disease Activity IndexBaseline, 4 years
Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) ResponseWeek 48
Proportion of Participants With Improvement in Lupus Quality of Life4 years
Change in Anti-double-stranded Deoxyribonucleic Acid LevelBaseline, 4 years
Occurrence of New Severe SLE FlaresBaseline through 4 years

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
940
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. 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. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
578
Total1,518

Baseline characteristics

CharacteristicLY 2127399 Q2WTotalLY2127399 Q4W
Age, Continuous43.6 years
STANDARD_DEVIATION 12.12
42.4 years
STANDARD_DEVIATION 11.93
40.4 years
STANDARD_DEVIATION 11.35
Anti-dsDNA Antibody Level (IU)82.9 International Unit/Milliliter (IU/mL)
STANDARD_DEVIATION 102.03
86.4 International Unit/Milliliter (IU/mL)
STANDARD_DEVIATION 102.23
92.3 International Unit/Milliliter (IU/mL)
STANDARD_DEVIATION 102.35
Ethnicity (NIH/OMB)
Hispanic or Latino
265 Participants454 Participants189 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
612 Participants926 Participants314 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
63 Participants138 Participants75 Participants
Race (NIH/OMB)
American Indian or Alaska Native
104 Participants198 Participants94 Participants
Race (NIH/OMB)
Asian
113 Participants209 Participants96 Participants
Race (NIH/OMB)
Black or African American
130 Participants163 Participants33 Participants
Race (NIH/OMB)
More than one race
14 Participants31 Participants17 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
579 Participants916 Participants337 Participants
Region of Enrollment
Argentina
16 Participants39 Participants23 Participants
Region of Enrollment
Australia
6 Participants9 Participants3 Participants
Region of Enrollment
Austria
1 Participants4 Participants3 Participants
Region of Enrollment
Belarus
4 Participants11 Participants7 Participants
Region of Enrollment
Brazil
18 Participants54 Participants36 Participants
Region of Enrollment
Bulgaria
7 Participants11 Participants4 Participants
Region of Enrollment
Canada
3 Participants6 Participants3 Participants
Region of Enrollment
Chile
7 Participants10 Participants3 Participants
Region of Enrollment
Colombia
18 Participants30 Participants12 Participants
Region of Enrollment
Croatia
1 Participants2 Participants1 Participants
Region of Enrollment
Ecuador
21 Participants41 Participants20 Participants
Region of Enrollment
Egypt
5 Participants9 Participants4 Participants
Region of Enrollment
France
1 Participants2 Participants1 Participants
Region of Enrollment
Germany
11 Participants15 Participants4 Participants
Region of Enrollment
Guatemala
14 Participants30 Participants16 Participants
Region of Enrollment
Hungary
21 Participants44 Participants23 Participants
Region of Enrollment
Israel
13 Participants22 Participants9 Participants
Region of Enrollment
Italy
1 Participants3 Participants2 Participants
Region of Enrollment
Japan
17 Participants36 Participants19 Participants
Region of Enrollment
Latvia
5 Participants9 Participants4 Participants
Region of Enrollment
Macedonia
5 Participants8 Participants3 Participants
Region of Enrollment
Malaysia
2 Participants2 Participants0 Participants
Region of Enrollment
Mexico
23 Participants51 Participants28 Participants
Region of Enrollment
New Zealand
2 Participants5 Participants3 Participants
Region of Enrollment
Peru
31 Participants69 Participants38 Participants
Region of Enrollment
Philippines
33 Participants59 Participants26 Participants
Region of Enrollment
Poland
22 Participants41 Participants19 Participants
Region of Enrollment
Puerto Rico
14 Participants15 Participants1 Participants
Region of Enrollment
Romania
13 Participants23 Participants10 Participants
Region of Enrollment
Russia
17 Participants38 Participants21 Participants
Region of Enrollment
Serbia
27 Participants63 Participants36 Participants
Region of Enrollment
Singapore
0 Participants1 Participants1 Participants
Region of Enrollment
South Africa
13 Participants31 Participants18 Participants
Region of Enrollment
South Korea
15 Participants29 Participants14 Participants
Region of Enrollment
Spain
10 Participants22 Participants12 Participants
Region of Enrollment
Taiwan
22 Participants42 Participants20 Participants
Region of Enrollment
Thailand
14 Participants24 Participants10 Participants
Region of Enrollment
Tunisia
21 Participants40 Participants19 Participants
Region of Enrollment
Ukraine
14 Participants31 Participants17 Participants
Region of Enrollment
United Kingdom
3 Participants5 Participants2 Participants
Region of Enrollment
United States
449 Participants532 Participants83 Participants
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score5.4 units on a scale
STANDARD_DEVIATION 3.81
5.2 units on a scale
STANDARD_DEVIATION 3.79
4.9 units on a scale
STANDARD_DEVIATION 3.74
Sex: Female, Male
Female
880 Participants1407 Participants527 Participants
Sex: Female, Male
Male
60 Participants111 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
464 / 937232 / 57837 / 81024 / 526
serious
Total, serious adverse events
129 / 93764 / 57857 / 81051 / 526

Outcome results

Primary

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.

Time frame: Baseline through 4 years

Population: All participants who received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
LY 2127399 Q2WPercentage of Participants With Adverse Events (AEs)73.3 percentage of participants
LY2127399 Q4WPercentage of Participants With Adverse Events (AEs)65.6 percentage of participants
Secondary

Change in Anti-double-stranded Deoxyribonucleic Acid Level

Time frame: Baseline, 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Secondary

Change in SLE Disease Activity Index

Time frame: Baseline, 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Secondary

Occurrence of New Severe SLE Flares

Time frame: Baseline through 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Secondary

Proportion of Participants With a Reduction in Steroid Dose

Time frame: Baseline through 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Secondary

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

Time frame: Week 48

Population: Zero participants analyzed. Data was not collected for analysis.

Secondary

Proportion of Participants With Improvement in Lupus Quality of Life

Time frame: 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026