Trial · NCT01488708

On Open-Label Study in Participants With Systemic Lupus Erythematosus

NCT01488708, Phase 3, Terminated, Eli Lilly and Company; results first posted 2018-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. On Open-Label Study in Participants With Systemic Lupus Erythematosus. Trials, record NCT01488708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488708

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: On Open-Label Study in Participants With Systemic Lupus Erythematosus
NCT number: NCT01488708
Status: Terminated
Phases: Phase 3
Enrollment: 1,518 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
Interventions: LY2127399, Placebo
First posted: 2011-12-08
Last updated: 2018-05-17
Results first posted: 2018-05-17
Limitations and caveats: Study terminated early due to lack of efficacy in parent studies.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Adverse Events (AEs)	Baseline through 4 years	All participants who received at least 1 dose of study drug.	percentage of participants	NUMBER
SECONDARY	Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response	Week 48	Zero participants analyzed. Data was not collected for analysis.
SECONDARY	Proportion of Participants With a Reduction in Steroid Dose	Baseline through 4 years	Zero participants analyzed. Data was not collected for analysis.
SECONDARY	Change in SLE Disease Activity Index	Baseline, 4 years	Zero participants analyzed. Data was not collected for analysis.
SECONDARY	Occurrence of New Severe SLE Flares	Baseline through 4 years	Zero participants analyzed. Data was not collected for analysis.
SECONDARY	Proportion of Participants With Improvement in Lupus Quality of Life	4 years	Zero participants analyzed. Data was not collected for analysis.
SECONDARY	Change in Anti-double-stranded Deoxyribonucleic Acid Level	Baseline, 4 years	Zero participants analyzed. Data was not collected for analysis.

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Adverse Events (AEs)	LY 2127399 Q2W		73.3		percentage of participants
Percentage of Participants With Adverse Events (AEs)	LY2127399 Q4W		65.6		percentage of participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LY 2127399 Q2W	940
Overall Study	STARTED	LY2127399 Q4W	578
Overall Study	Received at Least 1 Dose of Study Drug	LY 2127399 Q2W	937
Overall Study	Received at Least 1 Dose of Study Drug	LY2127399 Q4W	578
Overall Study	Participated in Follow Up	LY 2127399 Q2W	810
Overall Study	Participated in Follow Up	LY2127399 Q4W	526
Overall Study	COMPLETED	LY 2127399 Q2W	0
Overall Study	COMPLETED	LY2127399 Q4W	0
Overall Study	NOT COMPLETED	LY 2127399 Q2W	940
Overall Study	NOT COMPLETED	LY2127399 Q4W	578

Source ClinicalTrials.gov

Adverse events1,176

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	LY 2127399 Q2W Treatment	21	937	21
other	Abdominal pain	Gastrointestinal disorders	LY2127399 Q4W Treatment	3	578	3
other	Abdominal pain	Gastrointestinal disorders	LY 2127399 Q2W Follow Up	0	810	0
other	Abdominal pain	Gastrointestinal disorders	LY2127399 Q4W Follow Up	0	526	0
other	Abdominal pain upper	Gastrointestinal disorders	LY 2127399 Q2W Treatment	9	937	9
other	Abdominal pain upper	Gastrointestinal disorders	LY2127399 Q4W Treatment	12	578	12
other	Abdominal pain upper	Gastrointestinal disorders	LY 2127399 Q2W Follow Up	0	810	0
other	Abdominal pain upper	Gastrointestinal disorders	LY2127399 Q4W Follow Up	0	526	0
other	Diarrhoea	Gastrointestinal disorders	LY 2127399 Q2W Treatment	59	937	70
other	Diarrhoea	Gastrointestinal disorders	LY2127399 Q4W Treatment	18	578	21

1 to 10 of 1,176Source ClinicalTrials.gov

See all 1,176 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LY 2127399 Q2W Treatment
Total, all-cause mortality	LY2127399 Q4W Treatment
Total, all-cause mortality	LY 2127399 Q2W Follow Up
Total, all-cause mortality	LY2127399 Q4W Follow Up
Total, other adverse events	LY 2127399 Q2W Treatment	464	937
Total, other adverse events	LY2127399 Q4W Treatment	232	578
Total, other adverse events	LY 2127399 Q2W Follow Up	37	810
Total, other adverse events	LY2127399 Q4W Follow Up	24	526
Total, serious adverse events	LY 2127399 Q2W Treatment	129	937
Total, serious adverse events	LY2127399 Q4W Treatment	64	578

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01488708

GET https://conductscience.org/api/trials/v1/NCT01488708/events?page=2

API reference For AI assistants