A Study of LY2127399 in Patients With Systemic Lupus Erythematosus - Full Text View

Purpose

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	Intervention	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
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	1164
Study Start Date:	December 2010
Study Completion Date:	June 2015
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196091

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

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

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.

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 )
Study First Received:	September 3, 2010
Last Updated:	December 31, 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

ClinicalTrials.gov processed this record on September 20, 2017