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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT01205438
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : June 19, 2018
Last Update Posted : June 19, 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

  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
No text entered.

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

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

120mg LY2127399 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 Weeks   Placebo
STARTED   372   376   376 
Received At Least One Dose of Study Drug   371   374   376 
Participated in Follow Up   72   78   66 
COMPLETED   295   289   288 
NOT COMPLETED   77   87   88 
Adverse Event                19                17                24 
Death                1                1                3 
Entry Criteria Not Met                16                15                13 
Lack of Efficacy                14                11                14 
Lost to Follow-up                6                7                8 
Withdrawal by Subject                19                25                19 
Physician Decision                0                3                2 
Protocol Violation                2                7                4 
Sponsor Decision                0                1                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.
No text entered.

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

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

120mg LY2127399 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 Weeks   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 372   376   376   1124 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   42.3  (12.41)   41.2  (12.73)   41.9  (12.08)   41.8  (12.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   372   376   376   1124 
Female      342  91.9%      346  92.0%      349  92.8%      1037  92.3% 
Male      30   8.1%      30   8.0%      27   7.2%      87   7.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   372   376   376   1124 
Hispanic or Latino      110  29.6%      92  24.5%      99  26.3%      301  26.8% 
Not Hispanic or Latino      229  61.6%      233  62.0%      235  62.5%      697  62.0% 
Unknown or Not Reported      33   8.9%      51  13.6%      42  11.2%      126  11.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   372   376   376   1124 
American Indian or Alaska Native      31   8.3%      33   8.8%      30   8.0%      94   8.4% 
Asian      38  10.2%      34   9.0%      40  10.6%      112  10.0% 
Native Hawaiian or Other Pacific Islander      1   0.3%      2   0.5%      0   0.0%      3   0.3% 
Black or African American      43  11.6%      46  12.2%      51  13.6%      140  12.5% 
White      245  65.9%      247  65.7%      249  66.2%      741  65.9% 
More than one race      14   3.8%      14   3.7%      6   1.6%      34   3.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Ecuador         
Participants Analyzed   372   376   376   1124 
Ecuador   20   17   12   49 
Russia         
Participants Analyzed   372   376   376   1124 
Russia   12   19   12   43 
Romania         
Participants Analyzed   372   376   376   1124 
Romania   9   8   13   30 
Hungary         
Participants Analyzed   372   376   376   1124 
Hungary   18   17   18   53 
United States         
Participants Analyzed   372   376   376   1124 
United States   143   137   148   428 
United Kingdom         
Participants Analyzed   372   376   376   1124 
United Kingdom   3   3   3   9 
Malaysia         
Participants Analyzed   372   376   376   1124 
Malaysia   2   1   4   7 
India         
Participants Analyzed   372   376   376   1124 
India   11   13   16   40 
Spain         
Participants Analyzed   372   376   376   1124 
Spain   9   12   9   30 
New Zealand         
Participants Analyzed   372   376   376   1124 
New Zealand   3   4   1   8 
Canada         
Participants Analyzed   372   376   376   1124 
Canada   3   3   2   8 
Latvia         
Participants Analyzed   372   376   376   1124 
Latvia   3   4   2   9 
Taiwan         
Participants Analyzed   372   376   376   1124 
Taiwan   20   14   16   50 
Brazil         
Participants Analyzed   372   376   376   1124 
Brazil   23   25   22   70 
Mexico         
Participants Analyzed   372   376   376   1124 
Mexico   19   22   23   64 
South Africa         
Participants Analyzed   372   376   376   1124 
South Africa   14   17   7   38 
Israel         
Participants Analyzed   372   376   376   1124 
Israel   9   7   12   28 
Serbia         
Participants Analyzed   372   376   376   1124 
Serbia   19   25   32   76 
Australia         
Participants Analyzed   372   376   376   1124 
Australia   9   7   3   19 
France         
Participants Analyzed   372   376   376   1124 
France   2   1   1   4 
Tunisia         
Participants Analyzed   372   376   376   1124 
Tunisia   21   20   20   61 
Anti-dsDNA Antibody Level 
[Units: International Unit / Milliliter (IU/mL)]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   116.8  (118.17)   110.6  (113.51)   112.0  (116.60)   113.1  (116.03) 
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   10.4  (4.07)   10.4  (4.17)   9.8  (3.28)   10.2  (3.86) 
[1] 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.
Physician's Global Assessment (PGA) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   47.2  (15.45)   46.8  (15.60)   44.9  (16.57)   46.3  (15.90) 
[1] 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 is defined as increase of ≥0.3 points.
At Least One BILAG A or Two BILAG B Disease Activity Scores [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed   372   376   376   1124 
   230   218   209   657 
[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.

Time of Onset of Lupus 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   8.36  (8.500)   7.94  (7.615)   7.74  (7.078)   8.01  (7.748) 
Lupus Quality of Life (LupusQOL) Domain Scores [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Physical Health         
Participants Analyzed   366   364   365   1095 
Physical Health   59.2  (24.98)   59.1  (25.13)   56.9  (26.17)   58.4  (25.43) 
Emotional Health         
Participants Analyzed   366   364   365   1095 
Emotional Health   65.7  (25.19)   66.7  (23.99)   64.6  (26.22)   65.7  (25.14) 
Body Image         
Participants Analyzed   338   343   342   1023 
Body Image   61.1  (28.99)   63.2  (27.67)   61.9  (29.20)   62.1  (28.61) 
Pain         
Participants Analyzed   366   364   365   1095 
Pain   56.1  (28.40)   56.9  (26.75)   53.6  (28.62)   55.5  (27.95) 
Planning         
Participants Analyzed   366   364   365   1095 
Planning   61.2  (30.37)   62.1  (28.69)   59.0  (30.92)   60.8  (30.01) 
Fatigue         
Participants Analyzed   366   364   365   1095 
Fatigue   56.0  (26.39)   54.4  (25.54)   53.4  (27.14)   54.6  (26.36) 
Intimate Relationships         
Participants Analyzed   314   316   320   950 
Intimate Relationships   56.2  (33.92)   63.3  (31.53)   56.8  (34.21)   58.8  (33.36) 
Burden to Others         
Participants Analyzed   366   364   365   1095 
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.
[2] All enrolled participants with LupusQOL baseline data.
Brief Fatigue Inventory (BFI) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   372   376   376   1124 
   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 of 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:   Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)   [ Time Frame: Baseline, 52 weeks ]

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

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

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

10.  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 ]

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:   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 ]

14.  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 ]


  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: NCT01205438     History of Changes
Other Study ID Numbers: 13653
H9B-MC-BCDT ( Other Identifier: Eli Lilly and Company )
First Submitted: September 17, 2010
First Posted: September 20, 2010
Results First Submitted: March 24, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018