A Study of LY2127399 in Patients With Systemic Lupus Erythematosus

Study Description

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Brief Summary:

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in patients with active SLE.

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 Design

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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

Arms and Interventions

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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.
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.	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.
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

Outcome Measures

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Primary Outcome Measures :

1. Proportion of patients achieving an SLE Responder Index response at week 52 [ Time Frame: 52 weeks ]

Secondary Outcome Measures :

1. Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52 [ Time Frame: 52 weeks ]
2. Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level [ Time Frame: Baseline, 52 weeks ]
3. Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score [ Time Frame: Baseline, 52 weeks ]
4. Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ]
5. Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks [ Time Frame: 52 weeks ]
6. Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores [ Time Frame: Baseline, 52 weeks ]
7. Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQoL) composite and domain scores [ Time Frame: Baseline, 52 weeks ]
8. Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares [ Time Frame: Baseline through 52 weeks ]
9. Change from baseline to 52 week endpoint in PGA [ Time Frame: Baseline, 52 weeks ]
10. Proportion of patients with an increase in corticosteroids dose at 52 weeks [ Time Frame: 52 weeks ]
11. Change from baseline to 52 weeks endpoint in SELENA-SLEDAI disease activity score [ Time Frame: Baseline, 52 weeks ]
12. 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 ]
13. Change from baseline to 52 week endpoint BILAG numeric scores [ Time Frame: Baseline, 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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  Show 192 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.

Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. Epub 2016 May 24.

Hoffman RW, Merrill JT, Alarcón-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.

Isenberg DA, Petri M, Kalunian K, Tanaka Y, Urowitz MB, Hoffman RW, Morgan-Cox M, Iikuni N, Silk M, Wallace DJ. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):323-31. doi: 10.1136/annrheumdis-2015-207653. Epub 2015 Sep 3.

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
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