A Study of LY2127399 in Patients With Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT01196091 |
Recruitment Status
:
Completed
First Posted
: September 8, 2010
Last Update Posted
: February 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease | Drug: LY2127399 Drug: Placebo every 2 weeks Drug: Placebo every 4 weeks | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1164 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE) |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: LY2127399 every 2 weeks |
Drug: LY2127399
120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
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Experimental: LY2127399 every 4 wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
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Drug: LY2127399
120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Drug: Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
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Placebo Comparator: Placebo |
Drug: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
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- Proportion of patients achieving an SLE Responder Index response at week 52 [ Time Frame: 52 weeks ]
- Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52 [ Time Frame: 52 weeks ]
- Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level [ Time Frame: Baseline, 52 weeks ]
- Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score [ Time Frame: Baseline, 52 weeks ]
- Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ]
- Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks [ Time Frame: 52 weeks ]
- Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores [ Time Frame: Baseline, 52 weeks ]
- Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQoL) composite and domain scores [ Time Frame: Baseline, 52 weeks ]
- Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares [ Time Frame: Baseline through 52 weeks ]
- Change from baseline to 52 week endpoint in PGA [ Time Frame: Baseline, 52 weeks ]
- Proportion of patients with an increase in corticosteroids dose at 52 weeks [ Time Frame: 52 weeks ]
- Change from baseline to 52 weeks endpoint in SELENA-SLEDAI disease activity score [ Time Frame: Baseline, 52 weeks ]
- Proportion of patients achieving a response as measured by modified SRI with no BILAG A or no more than 1 BILAG B organ domain flares at 52 weeks [ Time Frame: 52 weeks ]
- Change from baseline to 52 week endpoint BILAG numeric scores [ Time Frame: Baseline, 52 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Have positive antinuclear antibodies (ANA)
- Agree not to become pregnant throughout the course of the trial
- Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening
Exclusion Criteria:
- Have active severe Lupus kidney disease
- Have active Central Nervous System or peripheral neurologic disease
- Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
- Have active or recent infection within 30 days of screening
- Have had a serious infection within 90 days of randomization
- Have evidence or test positive for Hepatitis B
- Have Hepatitis C
- Are human immunodeficiency virus (HIV) positive
- Have evidence of active or latent tuberculosis (TB)
- Presence of significant laboratory abnormalities at screening
- Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
- Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
- Have changed your dose of antimalarial drug in the past 30 days
- Have changed your dose of immunosuppressive drug in the past 90 days
- Have previously received rituximab

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196091

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01196091 History of Changes |
Other Study ID Numbers: |
13656 H9B-MC -BCDS ( Other Identifier: Eli Lilly and Company ) |
First Posted: | September 8, 2010 Key Record Dates |
Last Update Posted: | February 2, 2016 |
Last Verified: | December 2015 |
Keywords provided by Eli Lilly and Company:
Lupus SLE Systemic Lupus Erythematosis |
autoimmune disease LY2127399 Immune system disease |
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |