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: September 29, 2014
Last verified: September 2014
  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:


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 ]
  • 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 ]

Estimated Enrollment: 1140
Study Start Date: January 2011
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2127399 every 2 weeks Drug: LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
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.
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 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 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
  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: NCT01205438

  Show 185 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: NCT01205438     History of Changes
Other Study ID Numbers: 13653, H9B-MC-BCDT
Study First Received: September 17, 2010
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada
Ecuador: Public Health Ministry
France: Ministry of Health
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Ministry of Health
Latvia: Institutional Review Board
Malaysia: Ministry of Health
Mexico: Ministry of Health
Morocco: Ministry of Public Health
New Zealand: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia: Ethics Committee
South Africa: Department of Health
Spain: Ministry of Health
Taiwan: Department of Health
Tunisia: Ministry of Public Health

Keywords provided by Eli Lilly and Company:
SLE
Systemic Lupus Erythematosis
Lupus
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 October 29, 2014