Trial record 1 of 2 for:    NCT01205438
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A Study of LY2127399 in Patients With Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01205438
First received: September 17, 2010
Last updated: August 15, 2014
Last verified: August 2014

September 17, 2010
August 15, 2014
January 2011
August 2014   (final data collection date for primary outcome measure)
Proportion of patients achieving an SLE Responder Index response at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01205438 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA) [ 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 ]
  • 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 ]
  • 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 ]
  • 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 Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity score [ Time Frame: Baseline, 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 ]
  • Proportion of patients achieving a response as measured by modified SLE Responder Index (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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY2127399 in Patients With Systemic Lupus Erythematosus
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Systemic Lupus Erythematosus
  • Connective Tissue Disease
  • Autoimmune Disease
  • Drug: LY2127399
    120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
  • Drug: Placebo every 2 weeks
    Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
  • Drug: Placebo every 4 weeks
    Administered via subcutaneous injection for 52 weeks.
  • Experimental: LY2127399 every 2 weeks
    Intervention: Drug: LY2127399
  • Experimental: LY 2127399 every 4 weeks
    During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
    Interventions:
    • Drug: LY2127399
    • Drug: Placebo every 4 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo every 2 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1140
August 2015
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of SLE as defined 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 (SLE) 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Ecuador,   France,   Hungary,   India,   Israel,   Latvia,   Malaysia,   Mexico,   New Zealand,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Taiwan,   Tunisia,   United Kingdom
 
NCT01205438
13653, H9B-MC-BCDT
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP