A Study of LY2127399 in Patients With Systemic Lupus Erythematosus | Completed
A Study of LY2127399 in Patients With Systemic Lupus Erythematosus

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Systemic Lupus Erythematosus
  • Connective Tissue Disease
  • Autoimmune Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01205438
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : LY2127399, Drug : Placebo every 2 weeks, Drug : Placebo every 4 weeks

Study Arm Groups : LY2127399 every 2 weeks, LY 2127399 every 4 weeks, Placebo, LY 2127399 every 4 weeks

Intervention Type
See Interventions above
Primary Outcome Measures
  • Proportion of patients achieving an SLE Responder Index response at week 52; 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; 52 weeks; Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level; Baseline, 52 weeks; Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score; Baseline, 52 weeks; Time to first severe SLE flare (SFI); Baseline through 52 weeks; Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA); Baseline, 52 weeks; Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQOL) composite and domain scores; Baseline, 52 weeks; Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks; 52 weeks; Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores; Baseline, 52 weeks; Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares; Baseline through 52 weeks; Proportion of patients with an increase in corticosteroids dose at 52 weeks; 52 weeks; 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; Baseline, 52 weeks; Change from baseline to 52 week endpoint BILAG numeric scores; Baseline, 52 weeks; 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; 52 weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Guy's and St Thomas NHS Foundation Trust, of St Thomas' Hospital
London
SE1 7EH
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone
England
ME16 9QQ
Addenbrookes Hospital
Cambridge
CB2 0QQ
Research Site
London
E11 1NR
Poole
Dorset
BH15 2JB
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wigan
Lancashire
WN6 0LW
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
13653
Sponsor(s)
Eli Lilly and Company
Key Dates

Recruitment Start Date

Jan 2011

Recruitment End Date

Aug 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Sep 2010

Last Updated

26 Jun 2015