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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT01196091
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Interventions: Drug: LY2127399
Drug: Placebo every 2 weeks
Drug: Placebo every 4 weeks
Drug: Standard of Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Intent to Treat population (ITT) is all randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.

Reporting Groups
  Description
LY2127399 Every 2 Weeks LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
LY2127399 Every 4 Wks

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose

Participant Flow:   Overall Study
    LY2127399 Every 2 Weeks   LY2127399 Every 4 Wks   Placebo
STARTED   387   389   388 
Received at Least 1 Dose of Study Drug   386   389   387 
ITT-Received Drug and Excluded Sites   381   378   379 
Follow-Up   103   105   128 
COMPLETED   299   291   284 
NOT COMPLETED   88   98   104 
Adverse Event                22                27                26 
Death                3                2                2 
Entry Criteria Not Met                11                11                10 
Lack of Efficacy                15                12                17 
Lost to Follow-up                5                5                6 
Parent/Caregiver Decision                0                0                1 
Withdrawal by Subject                16                19                22 
Physician Decision                3                3                4 
Protocol Violation                1                3                3 
Sponsor Decision                6                5                4 
Excluded Site                5                11                8 
Randomized, No Study Drug Received                1                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug: except those at Sites 301 and 383, which were excluded due to suspected good clinical practice (GCP) issues.

Reporting Groups
  Description
LY2127399 Every 2 Weeks LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
LY2127399 Every 4 Wks

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Total Total of all reporting groups

Baseline Measures
   LY2127399 Every 2 Weeks   LY2127399 Every 4 Wks   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 381   378   379   1138 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.8  (12.51)   40.2  (11.21)   39.1  (11.69)   39.7  (11.82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      354  92.9%      352  93.1%      360  95.0%      1066  93.7% 
Male      27   7.1%      26   6.9%      19   5.0%      72   6.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      119  31.2%      116  30.7%      122  32.2%      357  31.4% 
Not Hispanic or Latino      233  61.2%      225  59.5%      229  60.4%      687  60.4% 
Unknown or Not Reported      29   7.6%      37   9.8%      28   7.4%      94   8.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      65  17.1%      55  14.6%      67  17.7%      187  16.4% 
Asian      68  17.8%      61  16.1%      66  17.4%      195  17.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.3%      0   0.0%      1   0.1% 
Black or African American      40  10.5%      41  10.8%      39  10.3%      120  10.5% 
White      204  53.5%      218  57.7%      205  54.1%      627  55.1% 
More than one race      4   1.0%      2   0.5%      2   0.5%      8   0.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Colombia   16   10   18   44 
Argentina   20   24   22   66 
Puerto Rico   3   7   11   21 
Singapore   0   2   0   2 
United States   128   133   116   377 
Philippines   26   14   22   62 
Japan   15   15   15   45 
Egypt   19   19   21   59 
Ukraine   23   22   29   74 
Thailand   14   9   11   34 
Belarus   4   6   2   12 
Canada   2   0   2   4 
Austria   3   3   1   7 
Macedonia   3   6   3   12 
Poland   19   16   19   54 
Guatemala   13   17   13   43 
South Korea   11   18   14   43 
Italy   1   7   2   10 
Bulgaria   8   11   12   31 
Chile   8   0   5   13 
Peru   32   33   34   99 
Germany   12   5   7   24 
Croatia   1   1   0   2 
Anti-dsDNA Antibody Level 
[Units: International Units/Milliliter (IU/mL)]
Mean (Standard Deviation)
 107.2  (113.50)   110.4  (111.58)   107.1  (112.40)   108.2  (112.41) 
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 10.2  (3.5)   10.4  (3.6)   10.7  (3.9)   10.4  (3.7) 
[1] 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.
Physician's Global Assessment (PGA) Score [1] 
[Units: Millimeters (mm)]
Mean (Standard Deviation)
 46.3  (15.7)   46.1  (16.2)   47.1  (16.10)   46.5  (16.0) 
[1] PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 0 to 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 range from 0, being worst possible to 100 being very active or best possible.
Time of Onset of Lupus 
[Units: Years]
Mean (Standard Deviation)
 7.5  (7.4)   8.1  (7.9)   6.4  (6.8)   7.3  (7.4) 
At Least One BILAG A or Two BILAG B Disease Activity Scores [1] 
[Units: Participants]
Count of Participants
       
Yes   360   340   347   1047 
No   21   38   31   90 
[1]

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.

The sum of participants in all Categories for the Measure does not equal the Overall Number of Baseline Participants in the Arm/Group because not all participants will have at least one BILAG A or Two BILAG B Disease Activity scores.

Lupus Quality of Life (lupus QOL) Domain Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Physical Health   59.2  (24.98)   59.1  (25.13)   56.9  (26.17)   58.4  (25.43) 
Emotional Health   65.7  (25.19)   66.7  (23.99)   64.6  (26.22)   65.7  (25.14) 
Body Image   61.1  (28.99)   63.2  (27.67)   61.9  (29.20)   62.1  (28.61) 
Pain   56.1  (28.40)   56.9  (26.75)   53.6  (28.62)   55.5  (27.95) 
Planning   61.2  (30.37)   62.1  (28.69)   59.0  (30.92)   60.8  (30.01) 
Fatigue   56.0  (26.39)   54.4  (25.54)   53.4  (27.14)   54.6  (26.36) 
Intimate Relationships   56.2  (33.92)   63.3  (31.53)   56.8  (34.21)   58.8  (33.36) 
Burden to Others   52.8  (30.70)   51.9  (30.31)   49.3  (32.39)   51.3  (31.15) 
[1] 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.
Brief Fatigue Inventory (BFI) Score (Worst Level of Fatigue in the Last 24 Hours) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.8  (2.57)   5.6  (2.81)   5.6  (2.81)   5.6  (2.73) 
[1] BFI is 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).


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving an SLE Responder Index Response at Week 52   [ Time Frame: 52 weeks ]

2.  Secondary:   Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52   [ Time Frame: 52 weeks ]

3.  Secondary:   Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level   [ Time Frame: Baseline, 52 weeks ]

4.  Secondary:   Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score   [ Time Frame: Baseline, 52 weeks ]

5.  Secondary:   Time to First Severe SLE Flare (SFI)   [ Time Frame: Baseline through 52 weeks ]

6.  Secondary:   Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks   [ Time Frame: 52 weeks ]

7.  Secondary:   Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores   [ Time Frame: Baseline, 52 weeks ]

8.  Secondary:   Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores   [ Time Frame: Baseline, 52 weeks ]

9.  Secondary:   Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares   [ Time Frame: Baseline through 52 weeks ]

10.  Secondary:   Change From Baseline to 52 Week Endpoint in PGA   [ Time Frame: Baseline, 52 weeks ]

11.  Secondary:   Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks   [ Time Frame: 52 weeks ]

12.  Secondary:   Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score   [ Time Frame: Baseline, 52 weeks ]

13.  Secondary:   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   [ Time Frame: 52 weeks ]

14.  Secondary:   Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline   [ Time Frame: Baseline through 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to product program termination, not all analyses were completed.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01196091     History of Changes
Other Study ID Numbers: 13656
H9B-MC -BCDS ( Other Identifier: Eli Lilly and Company )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: March 24, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018