Trial Outcomes & Findings for Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis (NCT NCT02931838)
NCT ID: NCT02931838
Last Updated: 2020-11-27
Results Overview
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
268 participants
Primary outcome timeframe
Day 1 to Day 85
Results posted on
2020-11-27
Participant Flow
268 participants were randomized in the study; One participant was randomized but did not receive study drug due to being lost to follow-up
Participant milestones
| Measure |
Placebo
Placebo for BMS-986165
|
BMS-986165 3MG QOD
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
BMS-986165 3mg capsules Every Day
|
BMS-986165 3MG BID
BMS-986165 3mg capsules Twice Daily
|
BMS-986165 6MG BID
BMS-986165 6mg capsules Twice Daily
|
BMS-986165 12MG QD
BMS-986165 12mg capsules Every Day
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
44
|
45
|
45
|
44
|
|
Overall Study
COMPLETED
|
31
|
34
|
36
|
42
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
8
|
3
|
6
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for BMS-986165
|
BMS-986165 3MG QOD
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
BMS-986165 3mg capsules Every Day
|
BMS-986165 3MG BID
BMS-986165 3mg capsules Twice Daily
|
BMS-986165 6MG BID
BMS-986165 6mg capsules Twice Daily
|
BMS-986165 12MG QD
BMS-986165 12mg capsules Every Day
|
|---|---|---|---|---|---|---|
|
Overall Study
Reason not provided by investigator
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Poor/non-compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
2
|
0
|
|
Overall Study
Subject request to discontinue treatment
|
4
|
3
|
3
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
1
|
3
|
1
|
Baseline Characteristics
All randomized and treated participants
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 11.93 • n=5 Participants • All randomized and treated participants
|
41.0 Years
STANDARD_DEVIATION 11.8 • n=7 Participants • All randomized and treated participants
|
45.0 Years
STANDARD_DEVIATION 13.77 • n=5 Participants • All randomized and treated participants
|
45.6 Years
STANDARD_DEVIATION 15.10 • n=4 Participants • All randomized and treated participants
|
42.8 Years
STANDARD_DEVIATION 12.90 • n=21 Participants • All randomized and treated participants
|
46.6 Years
STANDARD_DEVIATION 11.62 • n=8 Participants • All randomized and treated participants
|
44.6 Years
STANDARD_DEVIATION 12.96 • n=8 Participants • All randomized and treated participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • All randomized and treated participants
|
8 Participants
n=7 Participants • All randomized and treated participants
|
14 Participants
n=5 Participants • All randomized and treated participants
|
19 Participants
n=4 Participants • All randomized and treated participants
|
10 Participants
n=21 Participants • All randomized and treated participants
|
14 Participants
n=8 Participants • All randomized and treated participants
|
73 Participants
n=8 Participants • All randomized and treated participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants • All randomized and treated participants
|
36 Participants
n=7 Participants • All randomized and treated participants
|
30 Participants
n=5 Participants • All randomized and treated participants
|
26 Participants
n=4 Participants • All randomized and treated participants
|
35 Participants
n=21 Participants • All randomized and treated participants
|
30 Participants
n=8 Participants • All randomized and treated participants
|
194 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All randomized and treated participants
|
1 Participants
n=7 Participants • All randomized and treated participants
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=4 Participants • All randomized and treated participants
|
1 Participants
n=21 Participants • All randomized and treated participants
|
1 Participants
n=8 Participants • All randomized and treated participants
|
3 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants • All randomized and treated participants
|
6 Participants
n=7 Participants • All randomized and treated participants
|
5 Participants
n=5 Participants • All randomized and treated participants
|
5 Participants
n=4 Participants • All randomized and treated participants
|
9 Participants
n=21 Participants • All randomized and treated participants
|
6 Participants
n=8 Participants • All randomized and treated participants
|
36 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=7 Participants • All randomized and treated participants
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=4 Participants • All randomized and treated participants
|
0 Participants
n=21 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • All randomized and treated participants
|
1 Participants
n=7 Participants • All randomized and treated participants
|
0 Participants
n=5 Participants • All randomized and treated participants
|
1 Participants
n=4 Participants • All randomized and treated participants
|
0 Participants
n=21 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
2 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants • All randomized and treated participants
|
35 Participants
n=7 Participants • All randomized and treated participants
|
39 Participants
n=5 Participants • All randomized and treated participants
|
39 Participants
n=4 Participants • All randomized and treated participants
|
35 Participants
n=21 Participants • All randomized and treated participants
|
37 Participants
n=8 Participants • All randomized and treated participants
|
225 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=7 Participants • All randomized and treated participants
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=4 Participants • All randomized and treated participants
|
0 Participants
n=21 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • All randomized and treated participants
|
1 Participants
n=7 Participants • All randomized and treated participants
|
0 Participants
n=5 Participants • All randomized and treated participants
|
0 Participants
n=4 Participants • All randomized and treated participants
|
0 Participants
n=21 Participants • All randomized and treated participants
|
0 Participants
n=8 Participants • All randomized and treated participants
|
1 Participants
n=8 Participants • All randomized and treated participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 85Population: All Randomized and Treated Participants
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
|
6.7 Percentage
Interval 1.4 to 18.3
|
9.1 Percentage
Interval 2.5 to 21.7
|
38.6 Percentage
Interval 24.4 to 54.5
|
68.9 Percentage
Interval 53.4 to 81.8
|
66.7 Percentage
Interval 51.0 to 80.0
|
75.0 Percentage
Interval 59.7 to 86.8
|
PRIMARY outcome
Timeframe: Day 1 to day 115Population: All Randomized and Treated Participants
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
No. of participants with SAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
No. of participants with AEs
|
24 Participants
|
26 Participants
|
25 Participants
|
29 Participants
|
36 Participants
|
34 Participants
|
|
Number of Participants With Adverse Events
No. of participants discontinued due to AEs
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: All Randomized and Treated Participants
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
% of participants with PASI-50 at Day 85
|
31.1 Percentage
Interval 18.2 to 46.6
|
43.2 Percentage
Interval 28.3 to 59.0
|
68.2 Percentage
Interval 52.4 to 81.4
|
91.1 Percentage
Interval 78.8 to 97.5
|
77.8 Percentage
Interval 62.9 to 88.8
|
88.6 Percentage
Interval 75.4 to 96.2
|
|
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
% of participants with PASI-90 at Day 85
|
2.2 Percentage
Interval 0.1 to 11.8
|
6.8 Percentage
Interval 1.4 to 18.7
|
15.9 Percentage
Interval 6.6 to 30.1
|
44.4 Percentage
Interval 29.6 to 60.0
|
44.4 Percentage
Interval 29.6 to 60.0
|
43.2 Percentage
Interval 28.3 to 59.0
|
|
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
% of participants with PASI-100 at Day 85
|
0 Percentage
Interval 0.0 to 7.9
|
2.3 Percentage
Interval 0.1 to 12.0
|
0 Percentage
Interval 0.0 to 8.0
|
8.9 Percentage
Interval 2.5 to 21.2
|
17.8 Percentage
Interval 8.0 to 32.1
|
25.0 Percentage
Interval 13.2 to 40.3
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: All Randomized and Treated Participants
Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
|
6.7 Percentage
Interval 1.4 to 18.3
|
20.5 Percentage
Interval 9.8 to 35.3
|
38.6 Percentage
Interval 24.4 to 54.5
|
75.6 Percentage
Interval 60.5 to 87.1
|
64.4 Percentage
Interval 48.8 to 78.1
|
75.0 Percentage
Interval 59.7 to 86.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: All Randomized and Treated Participants
The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DLQI Scores on Day 85
|
-2.85 Score
Interval -4.33 to -1.37
|
-3.76 Score
Interval -5.15 to -2.38
|
-6.07 Score
Interval -8.07 to -4.08
|
-9.67 Score
Interval -11.42 to -7.93
|
-8.38 Score
Interval -10.72 to -6.03
|
-10.16 Score
Interval -12.27 to -8.06
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: All Randomized and Treated Participants
Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing \~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=45 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
n=44 Participants
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Change From Baseline in BSA on Day 85
|
-7.71 Percentage
Interval -11.88 to -3.54
|
-5.50 Percentage
Interval -8.17 to -2.83
|
-12.59 Percentage
Interval -18.28 to -6.89
|
-18.60 Percentage
Interval -23.69 to -13.52
|
-17.23 Percentage
Interval -20.85 to -13.6
|
-15.16 Percentage
Interval -18.64 to -11.69
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85Population: All participants who received any study medication and have any available concentration-time data.
Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo for BMS-986165
|
BMS-986165 3MG QOD
n=44 Participants
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3MG QD
n=44 Participants
BMS-986165 3 mg capsules every day
|
BMS-986165 3MG BID
n=45 Participants
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6MG BID
n=44 Participants
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12MG QD
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
|
2.024 ng/mL
Standard Deviation 3.7061
|
3.145 ng/mL
Standard Deviation 3.1588
|
14.819 ng/mL
Standard Deviation 9.1410
|
26.257 ng/mL
Standard Deviation 14.6483
|
17.824 ng/mL
Standard Deviation 22.7536
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
BMS-986165 3mg QOD
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
BMS-986165 3mg QD
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
BMS-986165 3mg BID
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
BMS-986165 6mg BID
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
BMS-986165 12mg QD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo for BMS-986165
|
BMS-986165 3mg QOD
n=44 participants at risk
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3mg QD
n=44 participants at risk
BMS-986165 3 mg capsules every day
|
BMS-986165 3mg BID
n=45 participants at risk
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6mg BID
n=45 participants at risk
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12mg QD
n=44 participants at risk
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo for BMS-986165
|
BMS-986165 3mg QOD
n=44 participants at risk
BMS-986165 3mg capsules Every Other Day
|
BMS-986165 3mg QD
n=44 participants at risk
BMS-986165 3 mg capsules every day
|
BMS-986165 3mg BID
n=45 participants at risk
BMS-986165 3 mg capsules twice daily
|
BMS-986165 6mg BID
n=45 participants at risk
BMS-986165 6 mg capsules twice daily
|
BMS-986165 12mg QD
n=44 participants at risk
BMS-986165 12 mg capsules every day
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.7%
3/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
9.1%
4/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
9.1%
4/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.5%
2/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.7%
3/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
11.4%
5/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
11.1%
5/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
15.6%
7/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.8%
3/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.5%
2/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.8%
3/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
8.9%
4/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
8.9%
4/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
15.9%
7/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Investigations
Blood immunoglobulin e increased
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.8%
3/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.5%
2/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.8%
3/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
9.1%
4/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
9.1%
4/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.7%
3/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.7%
3/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.5%
2/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
9.1%
4/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.2%
1/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.7%
3/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.5%
2/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
2.3%
1/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
6.8%
3/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
4.4%
2/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/45 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
0.00%
0/44 • 20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER