Trial · NCT01196091
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT01196091, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY2127399 in Participants With Systemic Lupus Erythematosus. Trials, record NCT01196091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01196091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
- NCT number
- NCT01196091
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,164 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Interventions
- LY2127399, Placebo every 2 weeks, Placebo every 4 weeks, Standard of Care
- First posted
- 2010-09-08
- Last updated
- 2018-06-12
- Results first posted
- 2018-06-12
- Limitations and caveats
- Due to product program termination, not all analyses were completed.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving an SLE Responder Index Response at Week 52 | 52 weeks | Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data. |
| Secondary | Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 | 52 weeks | A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included. |
| Secondary | Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level | Baseline, 52 weeks | Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE. |
| Secondary | Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score | Baseline, 52 weeks | SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. |
| Secondary | Time to First Severe SLE Flare (SFI) | Baseline through 52 weeks | The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity. Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1). |
| Secondary | Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks | 52 weeks | Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points. |
| Secondary | Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores | Baseline, 52 weeks | A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine). |
| Secondary | Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores | Baseline, 52 weeks | The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL. |
| Secondary | Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares | Baseline through 52 weeks | The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare. Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit. |
| Secondary | Change From Baseline to 52 Week Endpoint in PGA | Baseline, 52 weeks | Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving an SLE Responder Index Response at Week 52 | 52 weeks | Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues. | percentage of participants | NUMBER |
| SECONDARY | Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 | 52 weeks | All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent \>7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues. | percentage of partipants | NUMBER |
| SECONDARY | Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level | Baseline, 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52. | international units | MEAN |
| SECONDARY | Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score | Baseline, 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. | units on a scale | MEAN |
| SECONDARY | Time to First Severe SLE Flare (SFI) | Baseline through 52 weeks | Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis. | ||
| SECONDARY | Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks | 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores | Baseline, 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores | Baseline, 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result. | units on a scale | MEAN |
| SECONDARY | Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares | Baseline through 52 weeks | Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis. | ||
| SECONDARY | Change From Baseline to 52 Week Endpoint in PGA | Baseline, 52 weeks | All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. | millimeters | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving an SLE Responder Index Response at Week 52 | LY2127399 Every 2 Weeks | 31.8 | percentage of participants | ||
| Percentage of Participants Achieving an SLE Responder Index Response at Week 52 | LY2127399 Every 4 Wks | 35.2 | percentage of participants | ||
| Percentage of Participants Achieving an SLE Responder Index Response at Week 52 | Placebo | 29.3 | percentage of participants | ||
| Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 | LY2127399 Every 2 Weeks | 15.5 | percentage of partipants | ||
| Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 | LY2127399 Every 4 Wks | 17.0 | percentage of partipants | ||
| Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 | Placebo | 16.4 | percentage of partipants | ||
| Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level | LY2127399 Every 2 Weeks | 107.2 | Standard Deviation 113.50 | international units | |
| Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level | LY2127399 Every 4 Wks | 110.4 | Standard Deviation 111.58 | international units | |
| Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level | Placebo | 107.1 | Standard Deviation 112.40 | international units | |
| Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score | LY2127399 Every 2 Weeks | -4.7 | Standard Deviation 4.35 | units on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2127399 Every 2 Weeks | 387 | |
| Overall Study | STARTED | LY2127399 Every 4 Wks | 389 | |
| Overall Study | STARTED | Placebo | 388 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2127399 Every 2 Weeks | 386 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2127399 Every 4 Wks | 389 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 387 | |
| Overall Study | ITT-Received Drug and Excluded Sites | LY2127399 Every 2 Weeks | 381 | |
| Overall Study | ITT-Received Drug and Excluded Sites | LY2127399 Every 4 Wks | 378 | |
| Overall Study | ITT-Received Drug and Excluded Sites | Placebo | 379 | |
| Overall Study | Follow-Up | LY2127399 Every 2 Weeks | 103 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,338
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 | Dry eye | Eye disorders | LY2127399 Every 2 Weeks | 8 | 386 | 8 |
| other | Dry eye | Eye disorders | LY2127399 Every 4 Wks | 3 | 389 | 3 |
| other | Dry eye | Eye disorders | Placebo | 1 | 387 | 1 |
| other | Dry eye | Eye disorders | LY2127399 Every 2 Weeks, Follow Up | 0 | 103 | 0 |
| other | Dry eye | Eye disorders | LY2127399 Every 4 Wks, Follow Up | 0 | 105 | 0 |
| other | Dry eye | Eye disorders | Placebo, Follow Up | 0 | 128 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | LY2127399 Every 2 Weeks | 8 | 386 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | LY2127399 Every 4 Wks | 12 | 389 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 12 | 387 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | LY2127399 Every 2 Weeks, Follow Up | 0 | 103 | 0 |
1 to 10 of 1,338Source ClinicalTrials.gov
See all 1,338 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2127399 Every 2 Weeks | ||
| Total, all-cause mortality | LY2127399 Every 4 Wks | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | LY2127399 Every 2 Weeks, Follow Up | ||
| Total, all-cause mortality | LY2127399 Every 4 Wks, Follow Up | ||
| Total, all-cause mortality | Placebo, Follow Up | ||
| Total, other adverse events | LY2127399 Every 2 Weeks | 250 | 386 |
| Total, other adverse events | LY2127399 Every 4 Wks | 243 | 389 |
| Total, other adverse events | Placebo | 246 | 387 |
| Total, other adverse events | LY2127399 Every 2 Weeks, Follow Up | 13 | 103 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
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.
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.
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