Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis (NCT NCT02683785)
NCT ID: NCT02683785
Last Updated: 2021-01-11
Results Overview
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo).
COMPLETED
PHASE2
44 participants
Baseline (Day 1 Pre-dose) and Week 6
2021-01-11
Participant Flow
This was a multi-center, double-blind, placebo-controlled study to investigate the efficacy and safety of GSK3196165 in participants with inflammatory hand osteoarthritis. The study was conducted in five countries in Poland, United Kingdom, Netherlands, Germany and United States.
A total 121 participants were screened of which 77 were screen failures and 44 participants were enrolled in the study.
Participant milestones
| Measure |
Placebo
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 6.80 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 6.25 • n=7 Participants
|
58.8 Years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White /Caucasian/European
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 Pre-dose) and Week 6Population: Intent To Treat Population. Only non-missing data is included MMRM model.
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo).
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=20 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6
|
-1.34 Scores on scale
Standard Error 0.325
|
-1.70 Scores on scale
Standard Error 0.334
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12Population: Intent To Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score is calculated by sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 1, n=22, 20
|
-0.13 Scores on scale
Standard Error 0.152
|
-0.59 Scores on scale
Standard Error 0.160
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 2, n=21, 20
|
-0.48 Scores on scale
Standard Error 0.230
|
-0.86 Scores on scale
Standard Error 0.239
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 3, n=21, 20
|
-0.74 Scores on scale
Standard Error 0.279
|
-1.24 Scores on scale
Standard Error 0.289
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 4, n=21, 20
|
-0.91 Scores on scale
Standard Error 0.291
|
-1.65 Scores on scale
Standard Error 0.301
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 6, n=21, 20
|
-1.34 Scores on scale
Standard Error 0.325
|
-1.70 Scores on scale
Standard Error 0.334
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 8, n=20, 19
|
-1.27 Scores on scale
Standard Error 0.382
|
-2.10 Scores on scale
Standard Error 0.393
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 10, n=20, 19
|
-1.18 Scores on scale
Standard Error 0.376
|
-2.09 Scores on scale
Standard Error 0.389
|
|
Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit
Week 12, n=19, 18
|
-1.35 Scores on scale
Standard Error 0.402
|
-2.24 Scores on scale
Standard Error 0.416
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
Participants were required to complete a daily pain NRS based on their 24-hour worst hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The score is calculated as sum of daily 24 hours worst hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 6, n= 21, 20
|
-1.30 Scores on scale
Standard Error 0.328
|
-1.63 Scores on scale
Standard Error 0.337
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 1, n=22, 20
|
0.01 Scores on scale
Standard Error 0.174
|
-0.45 Scores on scale
Standard Error 0.183
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 10, n= 20, 19
|
-1.15 Scores on scale
Standard Error 0.394
|
-2.13 Scores on scale
Standard Error 0.407
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 8, n= 20, 19
|
-1.18 Scores on scale
Standard Error 0.394
|
-2.11 Scores on scale
Standard Error 0.406
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 12, n= 19, 18
|
-1.32 Scores on scale
Standard Error 0.415
|
-2.34 Scores on scale
Standard Error 0.430
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 2, n=21, 20
|
-0.42 Scores on scale
Standard Error 0.235
|
-0.69 Scores on scale
Standard Error 0.245
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 3, n=21, 20
|
-0.63 Scores on scale
Standard Error 0.269
|
-1.23 Scores on scale
Standard Error 0.278
|
|
Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit
Week 4, n= 21, 20
|
-0.72 Scores on scale
Standard Error 0.289
|
-1.51 Scores on scale
Standard Error 0.299
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)Population: Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.
Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 30 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is reported.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 1
|
0 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 8
|
18 Percentage of participants
|
50 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 2
|
0 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 3
|
5 Percentage of participants
|
23 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 4
|
14 Percentage of participants
|
41 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 6
|
23 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 10
|
18 Percentage of participants
|
50 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 12
|
23 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Follow up (Week 22)
|
23 Percentage of participants
|
27 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)Population: Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.
Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 50 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 2
|
0 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 3
|
0 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 4
|
0 Percentage of participants
|
23 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 6
|
14 Percentage of participants
|
27 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 8
|
14 Percentage of participants
|
41 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 10
|
9 Percentage of participants
|
36 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Week 12
|
14 Percentage of participants
|
41 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit
Follow up (Week 22)
|
9 Percentage of participants
|
23 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)Population: Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.
Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 30 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 1
|
0 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 2
|
0 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 3
|
0 Percentage of participants
|
23 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 4
|
0 Percentage of participants
|
32 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 6
|
9 Percentage of participants
|
36 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 8
|
9 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 10
|
14 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 12
|
14 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Follow up (Week 22)
|
14 Percentage of participants
|
32 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)Population: Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.
Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 50 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 2
|
0 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 3
|
0 Percentage of participants
|
14 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 4
|
0 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 6
|
5 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 8
|
5 Percentage of participants
|
32 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 10
|
5 Percentage of participants
|
27 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Week 12
|
9 Percentage of participants
|
36 Percentage of participants
|
|
Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit
Follow up (Week 22)
|
5 Percentage of participants
|
23 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
The AUSCAN Index is a self-administered questionnaire consisting of a 15-item scale which measures pain (5 items), stiffness (1 item) and degree of disability/physical function (9 items) during the preceding 48 hours. All items are rated on NRS scale with anchors "0" (none) to "10" (extreme). The scores for the pain and physical function components were calculated as simple summation of the item scores relating to that domain, so the Pain component ranges from 0 (i.e. all pain item scores are scored 0 \[none\]) to 50 (i.e. all pain item scores are scored 10 \[extreme\]), and the Physical Function component ranges from 0 (i.e. all physical function item scores are scored 0 \[none\]) to 90 (i.e. all physical function item scores are scored 10 \[extreme\]). The total AUSCAN score was calculated as simple summation of the 15 item scores and therefore ranges from 0 to 150. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 1, n=22, 20
|
0.8 Scores on scale
Standard Error 0.98
|
-1.9 Scores on scale
Standard Error 1.03
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 2, n=21, 21
|
-1.8 Scores on scale
Standard Error 1.27
|
-3.7 Scores on scale
Standard Error 1.28
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 4, n=22, 21
|
-3.5 Scores on scale
Standard Error 1.61
|
-7.2 Scores on scale
Standard Error 1.64
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 6, n=22, 21
|
-6.6 Scores on scale
Standard Error 1.72
|
-7.6 Scores on scale
Standard Error 1.76
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 8, n=20, 20
|
-4.9 Scores on scale
Standard Error 1.93
|
-8.7 Scores on scale
Standard Error 1.97
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 10, n=20, 20
|
-5.3 Scores on scale
Standard Error 1.82
|
-10.9 Scores on scale
Standard Error 1.87
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Pain, Week 12, n=21, 19
|
-4.6 Scores on scale
Standard Error 1.84
|
-9.3 Scores on scale
Standard Error 1.91
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 1, n= 22, 20
|
-0.4 Scores on scale
Standard Error 0.29
|
-0.6 Scores on scale
Standard Error 0.31
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 2, n= 21, 21
|
-0.8 Scores on scale
Standard Error 0.33
|
-1.1 Scores on scale
Standard Error 0.33
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 4, n= 22, 21
|
-1.2 Scores on scale
Standard Error 0.41
|
-1.8 Scores on scale
Standard Error 0.42
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 6, n= 22, 21
|
-1.4 Scores on scale
Standard Error 0.39
|
-1.6 Scores on scale
Standard Error 0.40
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 8, n= 20, 20
|
-1.2 Scores on scale
Standard Error 0.41
|
-1.9 Scores on scale
Standard Error 0.42
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 10, n= 20, 20
|
-1.6 Scores on scale
Standard Error 0.44
|
-2.2 Scores on scale
Standard Error 0.45
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Stiffness, Week 12, n= 21, 19
|
-1.5 Scores on scale
Standard Error 0.45
|
-2.2 Scores on scale
Standard Error 0.47
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 1, n=22, 20
|
-0.7 Scores on scale
Standard Error 2.08
|
-3.6 Scores on scale
Standard Error 2.16
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 2, n=21,21
|
-2.8 Scores on scale
Standard Error 2.35
|
-5.7 Scores on scale
Standard Error 2.37
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 4, n=22, 21
|
-6.4 Scores on scale
Standard Error 3.01
|
-11.3 Scores on scale
Standard Error 3.07
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 6, n=22, 21
|
-9.1 Scores on scale
Standard Error 3.25
|
-11.8 Scores on scale
Standard Error 3.32
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 8, n=20, 20
|
-8.3 Scores on scale
Standard Error 3.57
|
-13.2 Scores on scale
Standard Error 3.64
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 10, n=20, 20
|
-9.0 Scores on scale
Standard Error 3.82
|
-15.2 Scores on scale
Standard Error 3.92
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Physical function, Week 12, n=21, 19
|
-7.2 Scores on scale
Standard Error 3.74
|
-15.4 Scores on scale
Standard Error 3.87
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 1, n= 22, 20
|
-0.5 Scores on scale
Standard Error 3.07
|
-6.0 Scores on scale
Standard Error 3.20
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 2, n= 21, 21
|
-5.7 Scores on scale
Standard Error 3.66
|
-10.4 Scores on scale
Standard Error 3.70
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 4, n= 22, 21
|
-11.4 Scores on scale
Standard Error 4.72
|
-20.1 Scores on scale
Standard Error 4.83
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 6, n= 22, 21
|
-17.3 Scores on scale
Standard Error 5.17
|
-20.7 Scores on scale
Standard Error 5.28
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 8, n= 20, 20
|
-14.6 Scores on scale
Standard Error 5.70
|
-23.6 Scores on scale
Standard Error 5.81
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 10, n= 20, 20
|
-16.1 Scores on scale
Standard Error 5.88
|
-28.2 Scores on scale
Standard Error 6.04
|
|
Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.
Total, Week 12, n= 21, 19
|
-13.5 Scores on scale
Standard Error 5.92
|
-26.7 Scores on scale
Standard Error 6.12
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
Swollen Hand Joint Count was measured by the total number of soft tissue swollen hand joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joint across both hands. In case of missing observations for soft tissue swollen hand joints then the remaining observations were assessed and weighted by dividing the number presented by the number of non-missing, and by multiplying by 30 for the joint count. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 8, n = 20, 20
|
-3.0 Swollen joints
Standard Error 0.92
|
-2.8 Swollen joints
Standard Error 0.94
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 12, n = 21, 19
|
-2.9 Swollen joints
Standard Error 0.91
|
-3.1 Swollen joints
Standard Error 0.93
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 1, n = 22, 21
|
-0.3 Swollen joints
Standard Error 0.64
|
-0.3 Swollen joints
Standard Error 0.66
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 2, n = 21, 21
|
-1.6 Swollen joints
Standard Error 0.85
|
-1.2 Swollen joints
Standard Error 0.86
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 4, n = 22, 21
|
-1.6 Swollen joints
Standard Error 0.76
|
-2.1 Swollen joints
Standard Error 0.78
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 6, n = 22, 21
|
-3.7 Swollen joints
Standard Error 0.83
|
-2.3 Swollen joints
Standard Error 0.85
|
|
Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit
Week 10, n = 20, 20
|
-2.6 Swollen joints
Standard Error 1.08
|
-2.9 Swollen joints
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 10, and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data was included in the MMRM model.
Tender Hand Joint Count was measured by the total number of tender joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joints across both hands. A joint was considered tender if it was scored \>0 on the tender joint severity scale. Joints were rated 0=no pain/tenderness, 1=mild pain, 2=moderate pain and 3=severe pain. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 1, n= 22, 21
|
-0.6 Scores on scale
Standard Error 1.10
|
-1.8 Scores on scale
Standard Error 1.13
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 2, n= 21, 21
|
-1.7 Scores on scale
Standard Error 1.15
|
-2.1 Scores on scale
Standard Error 1.17
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 8, n= 20, 20
|
-2.4 Scores on scale
Standard Error 1.36
|
-3.9 Scores on scale
Standard Error 1.39
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 12, n= 21, 19
|
-3.5 Scores on scale
Standard Error 1.46
|
-4.0 Scores on scale
Standard Error 1.51
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 4, n= 22, 21
|
-1.1 Scores on scale
Standard Error 1.33
|
-3.0 Scores on scale
Standard Error 1.36
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 6, n= 22, 21
|
-3.7 Scores on scale
Standard Error 1.27
|
-4.2 Scores on scale
Standard Error 1.30
|
|
Change From Baseline in Number of Tender Hand Joints at Each Visit
Week 10, n= 20, 20
|
-3.7 Scores on scale
Standard Error 1.45
|
-4.4 Scores on scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-dose), Weeks 2, 4, 8, and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
Physicians were required to complete the global assessment of disease activity using single PhGA item with a NRS ranging from 0 (none) to 10 (extremely active). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity
Week 2, n= 19, 14
|
-1.8 Scores on scale
Standard Error 0.39
|
-1.5 Scores on scale
Standard Error 0.45
|
|
Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity
Week 4, n= 20, 15
|
-2.1 Scores on scale
Standard Error 0.44
|
-2.6 Scores on scale
Standard Error 0.50
|
|
Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity
Week 12, n= 18, 14
|
-2.7 Scores on scale
Standard Error 0.56
|
-3.0 Scores on scale
Standard Error 0.63
|
|
Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity
Week 8, n= 17, 15
|
-2.2 Scores on scale
Standard Error 0.52
|
-3.4 Scores on scale
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, and 12Population: Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.
Participants were required to complete the global assessment of disease activity using single PtGA item with an NRS ranging from 0 (very well) to 10 (very poor). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity
Week 2, n= 20, 21
|
-0.4 Scores on scale
Standard Error 0.36
|
-0.6 Scores on scale
Standard Error 0.35
|
|
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity
Week 4, n= 21, 21
|
-0.6 Scores on scale
Standard Error 0.42
|
-1.3 Scores on scale
Standard Error 0.42
|
|
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity
Week 8, n= 19, 20
|
-0.9 Scores on scale
Standard Error 0.47
|
-1.8 Scores on scale
Standard Error 0.46
|
|
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity
Week 12, n= 20, 19
|
-0.7 Scores on scale
Standard Error 0.46
|
-1.8 Scores on scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Up to Week 22Population: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who received at least one dose of study treatment (GSK3196165 or placebo) were included in Safety Population.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
11 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 22Population: Safety Population
Adverse events of special interest (AESI) included serious infections like serious respiratory infections and tuberculosis and other opportunistic infections. Number of participants with infections has been reported.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Number of Participants With Infections
Serious Infections
|
0 Participants
|
0 Participants
|
|
Number of Participants With Infections
Opportunistic Infections
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 22Population: Safety Population
Pulmonary events like pulmonary alveolar proteinosis (PAP), persistent (for 3 consecutive weeks) reduction in diffusing capacity of the lungs for carbon monoxide (DLCO) \> 15 percentage, persistent (for 3 consecutive weeks) cough and/or dyspnea and non- life threatening pulmonary changes related to surfactant accumulation is presented.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Number of Participants With Pulmonary Events
Persistent Cough
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pulmonary Events
Abnormal Lung Auscultation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pulmonary Events
Persistent dyspnea
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pulmonary Events
Persistent decrease in DLCO
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pulmonary Events
PAP
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 22Population: Intent-to-Treat Population. Only those participants with data available post-Baseline are reported.
Serum samples were collected at indicated time points for anti-drug antibody (ADA) measurements. Anti-GSK3196165 binding antibody detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. The number of participants with change from Baseline to any time post Baseline in the results of immunogenicity assessment as indicated by: negative to positive, positive to positive, positive to negative and negative to negative are presented.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 Participants
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Number of Participants With Anti-GSK3196165 Binding Antibodies
Negative to positive
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-GSK3196165 Binding Antibodies
Positive to negative
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-GSK3196165 Binding Antibodies
Positive to positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-GSK3196165 Binding Antibodies
Negative to negative
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22Population: PK Population
Blood samples were collected at indicated time points and CL/F was estimated using population PK analysis. Participants in the 'Safety' population who have at least one valid PK assessment were included Pharmacokinetic (PK) Population.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Apparent Clearance After Subcutaneous Administration (CL/F) of GSK3196165
|
4.94 Liters per day
Geometric Coefficient of Variation 68.8
|
—
|
SECONDARY outcome
Timeframe: Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22Population: PK Population.
Blood samples were collected at indicated time points and Vss/F was estimated using population PK analysis.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Apparent Steady State Volume of Distribution After Subcutaneous Administration (Vss/F) of GSK3196165
|
36.5 Liters
Geometric Coefficient of Variation 61.5
|
—
|
SECONDARY outcome
Timeframe: Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22Population: PK Population
Blood samples were collected at indicated time points and Ka was estimated using population PK analysis.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Absoption Rate Constant (Ka) of GSK3196165
|
0.205 Per day
Geometric Coefficient of Variation 72.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 3, Weeks 1, 4, 6, 12, follow up (Week 22)Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Serum Concentration of GSK3196165 by Visit
Day 3, n= 18
|
2457.05 Nanogram per milliliter
Geometric Coefficient of Variation 94.74
|
—
|
|
Serum Concentration of GSK3196165 by Visit
Week 1, n= 21
|
1767.55 Nanogram per milliliter
Geometric Coefficient of Variation 46.96
|
—
|
|
Serum Concentration of GSK3196165 by Visit
Week 4, n= 21
|
2821.12 Nanogram per milliliter
Geometric Coefficient of Variation 61.00
|
—
|
|
Serum Concentration of GSK3196165 by Visit
Week 6, n= 20
|
1802.09 Nanogram per milliliter
Geometric Coefficient of Variation 60.42
|
—
|
|
Serum Concentration of GSK3196165 by Visit
Week 12, n= 8
|
800.96 Nanogram per milliliter
Geometric Coefficient of Variation 176.33
|
—
|
|
Serum Concentration of GSK3196165 by Visit
Follow up (Week 22), n= 12
|
56.40 Nanogram per milliliter
Geometric Coefficient of Variation 346.41
|
—
|
Adverse Events
Placebo
GSK3196165 180mg
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 participants at risk
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
4.5%
1/22 • Number of events 1 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
4.5%
1/22 • Number of events 1 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
4.5%
1/22 • Number of events 1 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Participants randomized to Placebo group received total of 8 subcutaneous injections of placebo over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
GSK3196165 180mg
n=22 participants at risk
Participants randomized to GSK3196165 group received total of 8 doses of GSK3196165 over a 12-week treatment period. Participants were administered loading doses on Days 1, 8, 15, 22 and 29 which was followed by 3 doses every other week (Days 43, 57, 71).
|
|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
9.1%
2/22 • Number of events 2 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 3 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
General disorders
INJECTION SITE RASH
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 6 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 2 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 2 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.5%
1/22 • Number of events 1 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 3 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/22 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 2 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.1%
2/22 • Number of events 3 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
9.1%
2/22 • Number of events 2 • Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.
Non-serious AEs and SAE for Safety Population was reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER