Trial Outcomes & Findings for A Study in Participants With End-Stage Renal Disease (NCT NCT01200290)
NCT ID: NCT01200290
Last Updated: 2018-05-14
Results Overview
The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76
Results posted on
2018-05-14
Participant Flow
This study consisted of a 24-week treatment period (Weeks 0-24) and a follow-up period (up to Week 76). Participants who discontinued study drug administration were placed into the post-treatment follow-up period.
Participant milestones
| Measure |
LY2127399
LY2127399 was administered as a loading dose of 240-milligram (mg) subcutaneous (SC) injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Treatment Period
STARTED
|
18
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|
Treatment Period
Received at Least 1 Dose of Study Drug
|
18
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|
Treatment Period
COMPLETED
|
17
|
|
Treatment Period
NOT COMPLETED
|
1
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|
Post-Treatment Follow-Up Period
STARTED
|
18
|
|
Post-Treatment Follow-Up Period
COMPLETED
|
16
|
|
Post-Treatment Follow-Up Period
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
LY2127399
LY2127399 was administered as a loading dose of 240-milligram (mg) subcutaneous (SC) injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Treatment Period
Adverse Event
|
1
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Post-Treatment Follow-Up Period
Death
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2
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Baseline Characteristics
A Study in Participants With End-Stage Renal Disease
Baseline characteristics by cohort
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Age, Continuous
|
44.2 years
STANDARD_DEVIATION 12.09 • n=5 Participants
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|
Sex: Female, Male
Female
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10 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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|
Region of Enrollment
United States
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18 Participants
n=5 Participants
|
|
Panel Reactive Antibodies (PRA)
|
93.111 percentage of population
STANDARD_DEVIATION 10.593 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.
The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
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Change From Baseline in PRA
Week 8
|
-0.706 percentage of population
Standard Deviation 2.664
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Change From Baseline in PRA
Week 16
|
-2.176 percentage of population
Standard Deviation 3.575
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Change From Baseline in PRA
Week 24
|
-1.688 percentage of population
Standard Deviation 3.240
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Change From Baseline in PRA
Week 36
|
-2.353 percentage of population
Standard Deviation 3.499
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Change From Baseline in PRA
Week 52
|
-0.529 percentage of population
Standard Deviation 3.573
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Change From Baseline in PRA
Week 64
|
-1.706 percentage of population
Standard Deviation 4.497
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Change From Baseline in PRA
Week 76
|
-2.800 percentage of population
Standard Deviation 7.674
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PRIMARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.
The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population.
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
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Change From Baseline in Arcsine Transformed PRA Scores
Week 16
|
-0.059 units on a scale
Standard Deviation 0.101
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Change From Baseline in Arcsine Transformed PRA Scores
Week 24
|
-0.060 units on a scale
Standard Deviation 0.104
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Change From Baseline in Arcsine Transformed PRA Scores
Week 36
|
-0.078 units on a scale
Standard Deviation 0.099
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|
Change From Baseline in Arcsine Transformed PRA Scores
Week 52
|
-0.014 units on a scale
Standard Deviation 0.133
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Change From Baseline in Arcsine Transformed PRA Scores
Week 64
|
-0.053 units on a scale
Standard Deviation 0.124
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|
Change From Baseline in Arcsine Transformed PRA Scores
Week 76
|
-0.071 units on a scale
Standard Deviation 0.158
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Change From Baseline in Arcsine Transformed PRA Scores
Week 8
|
-0.022 units on a scale
Standard Deviation 0.086
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PRIMARY outcome
Timeframe: Baseline through Weeks 24, 52 and 76Population: All enrolled participants who received at least 1 dose of study drug and had single antigen reactivity assessed at baseline, during treatment and during follow-up.
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class I - Week 24
|
0 Participants
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|
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class I - Week 52
|
0 Participants
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|
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class I - Week 76
|
0 Participants
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|
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class II - Week 24
|
0 Participants
|
|
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class II - Week 52
|
0 Participants
|
|
Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up
Class II - Week 76
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24, 36 and 52Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline Ig value and at least 1 non-missing post-baseline Ig value.
Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels.
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Change From Baseline in Serum Immunoglobulin Levels
IgG2 at Week 52
|
0.046 grams/liter (g/L)
Standard Deviation 0.5918
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Change From Baseline in Serum Immunoglobulin Levels
IgM at Week 16
|
-0.295 grams/liter (g/L)
Standard Deviation 0.2895
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Change From Baseline in Serum Immunoglobulin Levels
IgM at Week 52
|
-0.197 grams/liter (g/L)
Standard Deviation 0.3032
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|
Change From Baseline in Serum Immunoglobulin Levels
IgA at Week 8
|
-0.305 grams/liter (g/L)
Standard Deviation 0.4552
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Change From Baseline in Serum Immunoglobulin Levels
IgA at Week 16
|
-0.261 grams/liter (g/L)
Standard Deviation 0.3983
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Change From Baseline in Serum Immunoglobulin Levels
IgA at Week 24
|
-0.409 grams/liter (g/L)
Standard Deviation 0.5467
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|
Change From Baseline in Serum Immunoglobulin Levels
IgA at Week 36
|
-0.325 grams/liter (g/L)
Standard Deviation 0.5715
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|
Change From Baseline in Serum Immunoglobulin Levels
IgA at Week 52
|
-0.098 grams/liter (g/L)
Standard Deviation 0.5090
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG at Week 8
|
-1.625 grams/liter (g/L)
Standard Deviation 1.8500
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Change From Baseline in Serum Immunoglobulin Levels
IgG at Week 16
|
-1.856 grams/liter (g/L)
Standard Deviation 1.5373
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG at Week 24
|
-2.048 grams/liter (g/L)
Standard Deviation 1.8486
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG at Week 36
|
-2.245 grams/liter (g/L)
Standard Deviation 2.1388
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG at Week 52
|
-0.625 grams/liter (g/L)
Standard Deviation 3.0933
|
|
Change From Baseline in Serum Immunoglobulin Levels
IgG1 at Week 8
|
-1.018 grams/liter (g/L)
Standard Deviation 1.4024
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG1 at Week 16
|
-1.459 grams/liter (g/L)
Standard Deviation 1.5242
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG1 at Week 24
|
-1.682 grams/liter (g/L)
Standard Deviation 1.8190
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Change From Baseline in Serum Immunoglobulin Levels
IgG1 at Week 36
|
-1.969 grams/liter (g/L)
Standard Deviation 1.6652
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG1 at Week 52
|
-0.668 grams/liter (g/L)
Standard Deviation 2.9531
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG2 at Week 8
|
-0.125 grams/liter (g/L)
Standard Deviation 0.3016
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Change From Baseline in Serum Immunoglobulin Levels
IgG2 at Week 16
|
-0.261 grams/liter (g/L)
Standard Deviation 0.3044
|
|
Change From Baseline in Serum Immunoglobulin Levels
IgG2 at Week 24
|
-0.274 grams/liter (g/L)
Standard Deviation 0.2693
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG2 at Week 36
|
-0.226 grams/liter (g/L)
Standard Deviation 0.3951
|
|
Change From Baseline in Serum Immunoglobulin Levels
IgG3 at Week 8
|
-0.046 grams/liter (g/L)
Standard Deviation 0.0847
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Change From Baseline in Serum Immunoglobulin Levels
IgG3 at Week 16
|
-0.072 grams/liter (g/L)
Standard Deviation 0.0601
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG3 at Week 24
|
-0.076 grams/liter (g/L)
Standard Deviation 0.0899
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG3 at Week 36
|
-0.061 grams/liter (g/L)
Standard Deviation 0.1074
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Change From Baseline in Serum Immunoglobulin Levels
IgG3 at Week 52
|
-0.022 grams/liter (g/L)
Standard Deviation 0.0761
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG4 at Week 8
|
0.013 grams/liter (g/L)
Standard Deviation 0.0511
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Change From Baseline in Serum Immunoglobulin Levels
IgG4 at Week 16
|
-0.009 grams/liter (g/L)
Standard Deviation 0.0512
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG4 at Week 24
|
-0.010 grams/liter (g/L)
Standard Deviation 0.0500
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|
Change From Baseline in Serum Immunoglobulin Levels
IgG4 at Week 36
|
-0.032 grams/liter (g/L)
Standard Deviation 0.0558
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Change From Baseline in Serum Immunoglobulin Levels
IgG4 at Week 52
|
0.019 grams/liter (g/L)
Standard Deviation 0.0899
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|
Change From Baseline in Serum Immunoglobulin Levels
IgM at Week 8
|
-0.208 grams/liter (g/L)
Standard Deviation 0.2650
|
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Change From Baseline in Serum Immunoglobulin Levels
IgM at Week 24
|
-0.266 grams/liter (g/L)
Standard Deviation 0.2781
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|
Change From Baseline in Serum Immunoglobulin Levels
IgM at Week 36
|
-0.302 grams/liter (g/L)
Standard Deviation 0.2449
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SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 24Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline tonsil B cell populations value and at least 1 non-missing post-baseline B cell populations value.
B cell population counts are: Total B cells \[cluster designation (CD)19+\], mature naïve B cells \[CD19+CD27-immunoglobulin D (IgD)+CD10-\], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2\&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Outcome measures
| Measure |
LY2127399
n=10 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
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|---|---|
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Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center Bm3, Bm4 at Week 1
|
26.705 relative percent of Lymphocytes
Standard Deviation 51.6762
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center Bm3, Bm4 at Week 24
|
104.890 relative percent of Lymphocytes
Standard Deviation 230.9829
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Total B cells at Week 1
|
12.732 relative percent of Lymphocytes
Standard Deviation 61.2266
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Total B cells at Week 24
|
-25.371 relative percent of Lymphocytes
Standard Deviation 40.1642
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Mature naïve at Week 1
|
-1.559 relative percent of Lymphocytes
Standard Deviation 4.9348
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Mature naïve at Week 24
|
-21.611 relative percent of Lymphocytes
Standard Deviation 12.6669
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Switched memory at Week 1
|
11.850 relative percent of Lymphocytes
Standard Deviation 27.6106
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Switched memory at Week 24
|
92.905 relative percent of Lymphocytes
Standard Deviation 74.1293
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Unswitched memory at Week 1
|
40.343 relative percent of Lymphocytes
Standard Deviation 82.3486
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Unswitched memory at Week 24
|
224.298 relative percent of Lymphocytes
Standard Deviation 331.6551
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center Bm2' at Week 1
|
-8.818 relative percent of Lymphocytes
Standard Deviation 21.9800
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center Bm2' at Week 24
|
-61.051 relative percent of Lymphocytes
Standard Deviation 20.9845
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center at Week 1
|
7.280 relative percent of Lymphocytes
Standard Deviation 58.0681
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Germinal center at Week 24
|
19.279 relative percent of Lymphocytes
Standard Deviation 102.9617
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1
|
46.508 relative percent of Lymphocytes
Standard Deviation 96.0036
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24
|
26.999 relative percent of Lymphocytes
Standard Deviation 79.5306
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Tr (CD19+CD27-IgD+CD10+) at Week 1
|
-8.977 relative percent of Lymphocytes
Standard Deviation 53.7335
|
|
Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil
Tr (CD19+CD27-IgD+CD10+) at Week24
|
-59.131 relative percent of Lymphocytes
Standard Deviation 27.2120
|
SECONDARY outcome
Timeframe: Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.
B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 1
|
35.303 relative percent of Lymphocytes
Standard Deviation 34.2864
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 64
|
-25.982 relative percent of Lymphocytes
Standard Deviation 49.3294
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 76
|
-32.467 relative percent of Lymphocytes
Standard Deviation 32.7608
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 64
|
2.059 relative percent of Lymphocytes
Standard Deviation 177.4749
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 4
|
-10.883 relative percent of Lymphocytes
Standard Deviation 24.1837
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 8
|
-28.765 relative percent of Lymphocytes
Standard Deviation 25.2472
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 16
|
-45.027 relative percent of Lymphocytes
Standard Deviation 23.1939
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 24
|
-52.115 relative percent of Lymphocytes
Standard Deviation 22.5144
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 36
|
-63.677 relative percent of Lymphocytes
Standard Deviation 17.2158
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Total B cells at Week 52
|
-60.808 relative percent of Lymphocytes
Standard Deviation 17.8105
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 1
|
-1.172 relative percent of Lymphocytes
Standard Deviation 11.6626
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 4
|
-14.222 relative percent of Lymphocytes
Standard Deviation 13.8931
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 8
|
-34.496 relative percent of Lymphocytes
Standard Deviation 15.9776
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 16
|
-47.957 relative percent of Lymphocytes
Standard Deviation 19.0080
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 24
|
-54.859 relative percent of Lymphocytes
Standard Deviation 23.8066
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 36
|
-54.030 relative percent of Lymphocytes
Standard Deviation 20.4375
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 52
|
-20.440 relative percent of Lymphocytes
Standard Deviation 29.5837
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 64
|
-1.237 relative percent of Lymphocytes
Standard Deviation 22.1831
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Mature naïve at Week 76
|
9.210 relative percent of Lymphocytes
Standard Deviation 21.7629
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 1
|
20.241 relative percent of Lymphocytes
Standard Deviation 41.7855
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 4
|
111.611 relative percent of Lymphocytes
Standard Deviation 73.4853
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 8
|
204.443 relative percent of Lymphocytes
Standard Deviation 118.2768
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 16
|
305.653 relative percent of Lymphocytes
Standard Deviation 198.0679
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 24
|
305.930 relative percent of Lymphocytes
Standard Deviation 197.4446
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 36
|
285.668 relative percent of Lymphocytes
Standard Deviation 238.3301
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 52
|
75.155 relative percent of Lymphocytes
Standard Deviation 85.9638
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 64
|
20.179 relative percent of Lymphocytes
Standard Deviation 42.5419
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Switched memory at Week 76
|
11.947 relative percent of Lymphocytes
Standard Deviation 37.6837
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 1
|
5.563 relative percent of Lymphocytes
Standard Deviation 41.2351
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 4
|
45.073 relative percent of Lymphocytes
Standard Deviation 61.3175
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 8
|
110.285 relative percent of Lymphocytes
Standard Deviation 87.0203
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 16
|
143.020 relative percent of Lymphocytes
Standard Deviation 113.1325
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 24
|
138.646 relative percent of Lymphocytes
Standard Deviation 121.7276
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 36
|
140.917 relative percent of Lymphocytes
Standard Deviation 123.0888
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 52
|
65.607 relative percent of Lymphocytes
Standard Deviation 109.5101
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 64
|
17.782 relative percent of Lymphocytes
Standard Deviation 41.1260
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Unswitched memory at Week 76
|
26.283 relative percent of Lymphocytes
Standard Deviation 52.1802
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1
|
-13.511 relative percent of Lymphocytes
Standard Deviation 29.4311
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4
|
-49.869 relative percent of Lymphocytes
Standard Deviation 23.7764
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8
|
-49.292 relative percent of Lymphocytes
Standard Deviation 18.5600
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16
|
-40.847 relative percent of Lymphocytes
Standard Deviation 36.9400
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24
|
-44.355 relative percent of Lymphocytes
Standard Deviation 32.0001
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36
|
10.080 relative percent of Lymphocytes
Standard Deviation 118.1582
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52
|
36.776 relative percent of Lymphocytes
Standard Deviation 136.3827
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 64
|
9.357 relative percent of Lymphocytes
Standard Deviation 210.4455
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 76
|
-7.396 relative percent of Lymphocytes
Standard Deviation 181.0879
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week1
|
-6.512 relative percent of Lymphocytes
Standard Deviation 23.6020
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week4
|
-42.852 relative percent of Lymphocytes
Standard Deviation 25.4319
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week8
|
-56.047 relative percent of Lymphocytes
Standard Deviation 13.9734
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 16
|
-56.886 relative percent of Lymphocytes
Standard Deviation 32.9379
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 24
|
-64.706 relative percent of Lymphocytes
Standard Deviation 24.3874
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 36
|
-41.231 relative percent of Lymphocytes
Standard Deviation 48.6871
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 52
|
6.504 relative percent of Lymphocytes
Standard Deviation 118.6276
|
|
Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood
Tr (CD19+CD27-IgD+CD10+) at Week 76
|
-45.425 relative percent of Lymphocytes
Standard Deviation 90.9992
|
SECONDARY outcome
Timeframe: Baseline, Weeks1, 4, 8, 16, 24, 36 and 52Population: All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.
B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 16
|
-46.861 percent change in absolute counts
Standard Deviation 33.8978
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 1
|
37.305 percent change in absolute counts
Standard Deviation 48.2410
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 4
|
-12.050 percent change in absolute counts
Standard Deviation 48.5995
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 8
|
-27.875 percent change in absolute counts
Standard Deviation 51.5586
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 24
|
-55.759 percent change in absolute counts
Standard Deviation 33.6090
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 36
|
-68.301 percent change in absolute counts
Standard Deviation 23.1588
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Total B cells at Week 52
|
-65.676 percent change in absolute counts
Standard Deviation 17.3689
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 1
|
37.533 percent change in absolute counts
Standard Deviation 60.6785
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 4
|
-23.351 percent change in absolute counts
Standard Deviation 47.2486
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 8
|
-52.128 percent change in absolute counts
Standard Deviation 39.7386
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 16
|
-72.891 percent change in absolute counts
Standard Deviation 19.8886
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 24
|
-81.367 percent change in absolute counts
Standard Deviation 16.4389
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 36
|
-85.213 percent change in absolute counts
Standard Deviation 12.9636
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Mature naïve at Week 52
|
-70.114 percent change in absolute counts
Standard Deviation 21.6407
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 1
|
64.309 percent change in absolute counts
Standard Deviation 68.7102
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 4
|
66.849 percent change in absolute counts
Standard Deviation 62.1042
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 8
|
83.774 percent change in absolute counts
Standard Deviation 76.5159
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 16
|
74.667 percent change in absolute counts
Standard Deviation 72.0109
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 24
|
56.192 percent change in absolute counts
Standard Deviation 117.0402
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 36
|
1.221 percent change in absolute counts
Standard Deviation 53.8382
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Switched memory at Week 52
|
-48.620 percent change in absolute counts
Standard Deviation 17.2563
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 1
|
51.590 percent change in absolute counts
Standard Deviation 98.1357
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 4
|
17.522 percent change in absolute counts
Standard Deviation 62.0773
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 8
|
35.339 percent change in absolute counts
Standard Deviation 84.7680
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 16
|
11.962 percent change in absolute counts
Standard Deviation 74.5105
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 24
|
-8.604 percent change in absolute counts
Standard Deviation 59.8587
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 36
|
-33.746 percent change in absolute counts
Standard Deviation 38.8791
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Unswitched memory at Week 52
|
-48.381 percent change in absolute counts
Standard Deviation 26.9717
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 1
|
22.103 percent change in absolute counts
Standard Deviation 72.4137
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 4
|
-57.052 percent change in absolute counts
Standard Deviation 30.7060
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 8
|
-64.282 percent change in absolute counts
Standard Deviation 25.8516
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 16
|
-71.138 percent change in absolute counts
Standard Deviation 26.0579
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 24
|
-80.746 percent change in absolute counts
Standard Deviation 12.1379
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 36
|
-75.133 percent change in absolute counts
Standard Deviation 20.0926
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD38++/+++CD24+++/+CD10+) at Week 52
|
-59.288 percent change in absolute counts
Standard Deviation 31.9767
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 1
|
25.018 percent change in absolute counts
Standard Deviation 44.8425
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 4
|
-47.991 percent change in absolute counts
Standard Deviation 42.3991
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 8
|
-70.447 percent change in absolute counts
Standard Deviation 20.1950
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 16
|
-76.085 percent change in absolute counts
Standard Deviation 24.0089
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 24
|
-87.204 percent change in absolute counts
Standard Deviation 11.6008
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 36
|
-84.531 percent change in absolute counts
Standard Deviation 14.5977
|
|
Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood
Tr(CD19+CD27-IgD+CD10+) at Week 52
|
-69.306 percent change in absolute counts
Standard Deviation 29.8739
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Outcome measures
| Measure |
LY2127399
n=18 Participants
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
|
Population Pharmacokinetics (PK): Constant Clearance
|
5.65 milliliters/hour (mL/h)
Standard Error 9.72
|
Adverse Events
LY2127399
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2127399
n=18 participants at risk
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
|
Nervous system disorders
Neuropathy peripheral
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Toxic encephalopathy
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
LY2127399
n=18 participants at risk
LY2127399 was administered as a loading dose of 240-mg SC injection at Week 0 followed by maintenance doses of 120-mg SC injections every 4 weeks at Weeks 4, 8, 12, 16 and 20.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
2/18 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Left ventricular hypertrophy
|
5.6%
1/18 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism
|
11.1%
2/18 • Number of events 2
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Peptic ulcer
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Catheter site pain
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Chest discomfort
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Feeling abnormal
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Injection site extravasation
|
11.1%
2/18 • Number of events 3
|
|
General disorders
Injection site pain
|
94.4%
17/18 • Number of events 83
|
|
General disorders
Medical device complication
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Oedema peripheral
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Thrombosis in device
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
5.6%
1/18 • Number of events 1
|
|
Immune system disorders
Kidney transplant rejection
|
5.6%
1/18 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
11.1%
2/18 • Number of events 5
|
|
Infections and infestations
Clostridium difficile infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Labyrinthitis
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
11.1%
2/18 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
2/18 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Cardiac murmur
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Lipase increased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Migraine
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Syncope
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Uraemic neuropathy
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Communication disorder
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Renal pain
|
5.6%
1/18 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine cyst
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
3/18 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Hypotension
|
27.8%
5/18 • Number of events 7
|
|
Vascular disorders
Iliac vein occlusion
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
5.6%
1/18 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60