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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Autoimmune Diseases Connective Tissue Disorders 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQoL) composite and domain scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 week endpoint in PGA [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Proportion of patients with an increase in corticosteroids dose at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 weeks endpoint in SELENA-SLEDAI disease activity score [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline to 52 week endpoint BILAG numeric scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1140
Study Start Date:	December 2010
Estimated Study Completion Date:	May 2015
Estimated 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
Genders Eligible for Study:	Both
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

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

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 208 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

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01196091 History of Changes
Other Study ID Numbers:	13656, H9B-MC -BCDS
Study First Received:	September 3, 2010
Last Updated:	May 14, 2013
Health Authority:	United States: Food and Drug Administration Argentina: Ministry of Health Austria: Federal Office for Safety in Health Care Belarus: Ministry of Health Bulgaria: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Egypt: Ministry of Health, Drug Policy and Planning Center Germany: Ministry of Health Guatemala: Ministry of Public Health and Social Assistance Italy: Ministry of Health Japan: Pharmaceuticals and Medical Devices Agency Korea: Ministry for Health, Welfare and Family Affairs Macedonia: Ministry of Health Peru: Ministry of Health Philippines: Bureau of Food and Drugs Poland: Ministry of Health Singapore: Health Sciences Authority Thailand: Ministry of Public Health Turkey: Ministry of Health Ukraine: Ministry of Health

Keywords provided by Eli Lilly and Company:

Lupus
SLE
Systemic Lupus Erythematosis

autoimmune disease
LY2127399
Immune system disease

Additional relevant MeSH terms:

Autoimmune Diseases
Connective Tissue Diseases
Lupus Erythematosus, Systemic
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013