Trial Outcomes & Findings for An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea (NCT NCT04167462)

Results Overview

static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

220 participants

Primary outcome timeframe

At week 16

Results posted on

2023-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: BMS-986165 Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo Participants received a placebo tablet once daily. After Week 16, participants were transferred to a 6 mg tablet of BMS-986165 once daily
Overall Study STARTED	146	74
Overall Study COMPLETED	132	64
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: BMS-986165 Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo Participants received a placebo tablet once daily. After Week 16, participants were transferred to a 6 mg tablet of BMS-986165 once daily
Overall Study Other reasons	3	2
Overall Study Withdrawal by Subject	6	7
Overall Study Adverse Event	4	0
Overall Study Pregnancy	1	0
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: BMS-986165 n=146 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily	Total n=220 Participants Total of all reporting groups
Age, Continuous	40.3 Years STANDARD_DEVIATION 12.19 • n=5 Participants	41.2 Years STANDARD_DEVIATION 12.33 • n=7 Participants	40.6 Years STANDARD_DEVIATION 12.22 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	57 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Chinese	118 Participants n=5 Participants	62 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Korean	28 Participants n=5 Participants	12 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 16

Population: All treated participants. Participants missing results at week 16 due to COVID-19 are excluded.

static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=144 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With sPGA Response of 0 or 1	55.6 Percentage of participants Interval 47.4 to 63.7	6.8 Percentage of participants Interval 1.0 to 12.5

PRIMARY outcome

Timeframe: At week 16

Population: All treated participants. Participants missing results at week 16 due to COVID-19 are excluded.

Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=144 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PASI 75 Response	68.8 Percentage of participants Interval 61.2 to 76.3	8.1 Percentage of participants Interval 1.9 to 14.3

SECONDARY outcome

Timeframe: At week 16

Population: All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

Psoriasis Area and Severity Index (PASI) 90 response is an assessment defined as the percentage of participants who experience at least a 90% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=144 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PASI 90 Response	38.2 Percentage of participants Interval 30.3 to 46.1	1.4 Percentage of participants Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: At week 16

Population: All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

Psoriasis Area and Severity Index (PASI) 100 response is an assessment defined as the percentage of participants who experience at least a 100% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=144 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PASI 100 Response	4.2 Percentage of participants Interval 0.9 to 7.4	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At week 16

Population: All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

static Physician Global Assessment (sPGA) 0 response is defined as the percentage of participants with a sPGA score of 0 with at least 2-point improvement from baseline as assessed at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=144 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With sPGA 0 Response	13.9 Percentage of participants Interval 8.2 to 19.5	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: Participants with a baseline PSSD symptom score ≥ 1. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score is defined as the percentage of participants with a PSSD score of 0 among participants with a baseline PSSD symptom score ≥ 1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=142 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=73 Participants Participants received a placebo tablet once daily
Change From Baseline in PSSD Symptom Score	-29.4 Score on a scale Standard Deviation 23.21	-1.8 Score on a scale Standard Deviation 25.32

SECONDARY outcome

Timeframe: At week 16

Population: Participants with a baseline ss-PGA score ≥3. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

Scalp specific Physician's Global Assessment (ss-PGA) 0 or 1 assessed at Week 16 as a percentage of participants with a ss-PGA score 0 or 1 among participants with a baseline ss-PGA score ≥3. The ss-PGA is assessed at each visit throughout the study in participants that have evidence of scalp psoriasis at baseline. If there is evidence of scalp involvement, scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=105 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=51 Participants Participants received a placebo tablet once daily
The Percentage of Participants With Ss-PGA Score of 0 or 1	62.9 Percentage of participants Interval 53.6 to 72.1	9.8 Percentage of participants Interval 1.6 to 18.0

SECONDARY outcome

Timeframe: At week 16

Population: Participants with a baseline DLQI score ≥2. Pre-specified data collected for Arms 1 and 2 at Week 16.

Dermatology Life Quality Index 0 or 1 assessed at Week 16 as a percentage of participants with a DLQI score of 0 or 1 among participants with a baseline DLQI score ≥2. 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 where a higher value signifies higher severity, with 0="not at all", 1="a little", 2="a lot", or 3="very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). Interpretation of DLQI scores is as follows: 1. 0-1 = no effect at all on participant's life 2. 2-5 = small effect on participant's life 3. 6-10 = moderate effect on participant's life 4. 11-20 = very large effect on participant's life 5. 21-30 = extremely large effect on participant's life

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=140 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=69 Participants Participants received a placebo tablet once daily
The Percentage of Participants With DLQI Score of 0 or 1	36.4 Percentage of participants Interval 28.5 to 44.4	11.6 Percentage of participants Interval 4.0 to 19.1

SECONDARY outcome

Timeframe: At week 16

Population: Participants with a baseline PGA-F score ≥3. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16.

Physician's Global Assessment of Fingernail Psoriasis (PGA-F) score of 0 or 1 assessed at Week 16 as a percentage of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score ≥3. If a participant shows evidence of psoriatic fingernail involvement, the assessment will be performed at each subsequent visit to assess severity and improvement over time. Only participants with a PGA-F score at baseline will be assessed throughout the study. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=46 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=24 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PGA-F Score of 0 or 1	19.6 Percentage of participants Interval 8.1 to 31.0	4.2 Percentage of participants Interval 0.0 to 12.2

SECONDARY outcome

Timeframe: At week 16

Population: Participants with a baseline PSSD symptom score ≥1. Pre-specified data collected for Arms 1 and 2 at Week 16.

Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 assessed as a percentage of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions included in the symptom score and multiplying by 10. scores range from 0-100, where 0 representing the least severe symptom and 100 the most severe.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=142 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=73 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PSSD Symptom Score of 0	4.9 Percentage of participants Interval 1.4 to 8.5	1.4 Percentage of participants Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: At week 16

Population: Participants with a baseline pp-PGA score ≥3. Pre-specified data collected for Arms 1 and 2 at Week 16.

Palmoplantar PGA (pp-PGA) 0/1 assessed as a percentage of participants with a pp-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3. This measure will be used for participants with palmoplantar (finger and toe surfaces) involvement at baseline. Only participants with baseline palmoplantar involvement will continue to have these assessments at each subsequent visit throughout the study. The pp-PGA uses a 5-point (0-4) overall severity scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=15 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=7 Participants Participants received a placebo tablet once daily
The Percentage of Participants With Pp-PGA Score of 0 or 1	66.7 Percentage of participants Interval 42.8 to 90.5	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At week 52

Population: All treated participants. Data is represented from participants original randomization arm.

Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 52 as compared with participants that are PASI 75 responders at Week 16. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=145 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With PASI 75 Response at Week 52	71.0 Percentage of participants Interval 63.7 to 78.4	70.3 Percentage of participants Interval 59.9 to 80.7

SECONDARY outcome

Timeframe: At week 52

Population: All treated participants

static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 52 among participants that are sPGA 0 or 1 responders at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.

Outcome measures

Outcome measures
Measure	Arm 1: BMS-986165 n=145 Participants Participants received a 6 mg tablet of BMS-986165 once daily	Arm 2: Placebo n=74 Participants Participants received a placebo tablet once daily
The Percentage of Participants With sPGA Response of 0 or 1 at Week 52	51.0 Percentage of participants Interval 42.9 to 59.2	52.7 Percentage of participants Interval 41.3 to 64.1

Adverse Events

Placebo Week 0 up to Week 16

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

BMS-986165 Week 0 up to Week 52

Serious events: 4 serious events

Other events: 55 other events

Deaths: 0 deaths

BMS-986165 Week 16 up to Week 52

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Week 0 up to Week 16 n=74 participants at risk Participants received a placebo tablet once daily from Week 0 up to Week 16	BMS-986165 Week 0 up to Week 52 n=146 participants at risk Participants received a 6 mg tablet of BMS-986165 once daily from Week 0 up to Week 52	BMS-986165 Week 16 up to Week 52 n=68 participants at risk Participants from the placebo group were switched to receive a 6 mg tablet of BMS-986165 once daily from Week 16 up to Week 52.
Hepatobiliary disorders Cholecystitis	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.68% 1/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Gastroenteritis	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.68% 1/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Gastroenteritis shigella	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.68% 1/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.68% 1/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Injury, poisoning and procedural complications Hepatobiliary procedural complication	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.68% 1/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
General disorders Cyst	1.4% 1/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Injury, poisoning and procedural complications Comminuted fracture	1.4% 1/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.4% 1/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).

Other adverse events

Other adverse events
Measure	Placebo Week 0 up to Week 16 n=74 participants at risk Participants received a placebo tablet once daily from Week 0 up to Week 16	BMS-986165 Week 0 up to Week 52 n=146 participants at risk Participants received a 6 mg tablet of BMS-986165 once daily from Week 0 up to Week 52	BMS-986165 Week 16 up to Week 52 n=68 participants at risk Participants from the placebo group were switched to receive a 6 mg tablet of BMS-986165 once daily from Week 16 up to Week 52.
Gastrointestinal disorders Mouth ulceration	5.4% 4/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	7.5% 11/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	0.00% 0/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Nasopharyngitis	8.1% 6/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	6.8% 10/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	5.9% 4/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Upper respiratory tract infection	18.9% 14/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	17.8% 26/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	5.9% 4/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	1.4% 2/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	5.9% 4/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Nervous system disorders Headache	0.00% 0/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	5.5% 8/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	5.9% 4/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Skin and subcutaneous tissue disorders Psoriasis	2.7% 2/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	2.7% 4/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	11.8% 8/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Folliculitis	5.4% 4/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	3.4% 5/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	1.5% 1/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Infections and infestations Pharyngitis	5.4% 4/74 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	1.4% 2/146 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).	1.5% 1/68 • SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).

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