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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01205438
Registration number
NCT01205438
Ethics application status
Date submitted
17/09/2010
Date registered
20/09/2010
Date last updated
17/07/2018
Titles & IDs
Public title
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
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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)
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Secondary ID [1]
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H9B-MC-BCDT
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Secondary ID [2]
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13653
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Connective Tissue Disease
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Autoimmune Disease
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Skin
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Other skin conditions
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY2127399
Treatment: Drugs - Placebo every 2 weeks
Treatment: Drugs - Placebo every 4 weeks
Experimental: LY2127399 every 2 weeks -
Experimental: LY2127399 every 4 weeks - During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Placebo Comparator: Placebo -
Treatment: Drugs: LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Treatment: Drugs: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Treatment: Drugs: Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving an SLE Responder Index Response at Week 52
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Assessment method [1]
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Percentage of participants with a = 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
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Assessment method [1]
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A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.
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Timepoint [1]
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52 weeks
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Secondary outcome [2]
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Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
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Assessment method [2]
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Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
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Timepoint [2]
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Baseline, 52 weeks
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Secondary outcome [3]
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Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
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Assessment method [3]
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SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
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Timepoint [3]
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Baseline, 52 weeks
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Secondary outcome [4]
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Time to First Severe SLE Flare (SFI)
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Assessment method [4]
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The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.
Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1).
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Timepoint [4]
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Baseline through 52 weeks
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Secondary outcome [5]
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Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
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Assessment method [5]
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PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of = 0.30 points from Baseline.
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Timepoint [5]
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Baseline, 52 weeks
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Secondary outcome [6]
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Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
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Assessment method [6]
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The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
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Timepoint [6]
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Baseline, 52 weeks
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Secondary outcome [7]
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Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
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Assessment method [7]
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Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of = 0.30 points from Baseline.
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Timepoint [7]
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52 weeks
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Secondary outcome [8]
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Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
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Assessment method [8]
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A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).
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Timepoint [8]
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Baseline, 52 weeks
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Secondary outcome [9]
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Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
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Assessment method [9]
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The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.
Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit.
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Timepoint [9]
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Baseline through 52 weeks
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Secondary outcome [10]
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Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
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Assessment method [10]
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An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.
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Timepoint [10]
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52 weeks
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Secondary outcome [11]
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Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
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Assessment method [11]
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Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
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Timepoint [11]
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Baseline, 52 weeks
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Secondary outcome [12]
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Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
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Assessment method [12]
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The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.
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Timepoint [12]
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Baseline through 52 weeks
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Secondary outcome [13]
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Percentage of Participants 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
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Assessment method [13]
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Percentage of participants with a = 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)
SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
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Timepoint [13]
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52 weeks
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Eligibility
Key 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 a screening SELENA-SLEDAI score =6. (The participant must be actively exhibiting
all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
1124
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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0
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. - St Leonards
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Recruitment hospital [2]
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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. - Cairns
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Recruitment hospital [3]
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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. - Maroochydore
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Recruitment hospital [4]
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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. - Clayton
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Recruitment hospital [5]
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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. - Heidelberg
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Recruitment hospital [6]
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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. - Malvern East
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4870 - Cairns
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3081 - Heidelberg
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Recruitment postcode(s) [6]
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3145 - Malvern East
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Recruitment outside Australia
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Alabama
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Ontario
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India
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India
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India
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Trivandrum
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Israel
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Haifa
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Israel
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Israel
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Israel
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Israel
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Zerifin
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Latvia
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Riga
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Mexico City
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Mexico
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San Luis
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Tijuana
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New Zealand
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Hamilton
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New Zealand
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Otahuhu
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Summary
Brief 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
participants with active SLE.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01205438
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01205438
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