Trial Outcomes & Findings for A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting (NCT NCT05701995)

NCT ID: NCT05701995

Last Updated: 2025-09-10

Results Overview

Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey 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 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: At Week 16
• Results posted on: 2025-09-10

Participant Flow

A total of 180 participants were randomized and of these 178 received at least one dose of study treatment.

Participant milestones

Measure	BMS-986165 6mg QD Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo Participants received placebo daily (QD)
Pre-Treatment STARTED	120	60
Pre-Treatment Full Analysis Set Sub-population	107	49
Pre-Treatment COMPLETED	119	59
Pre-Treatment NOT COMPLETED	1	1
Treatment STARTED	119	59
Treatment COMPLETED	104	49
Treatment NOT COMPLETED	15	10

Reasons for withdrawal

Measure	BMS-986165 6mg QD Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo Participants received placebo daily (QD)
Pre-Treatment Randomization Error	1	1
Treatment Withdrawal by Subject	8	4
Treatment Lost to Follow-up	2	3
Treatment Adverse Event	3	1
Treatment Other Reason	1	1
Treatment Death	1	0
Treatment Physician Decision	0	1

Baseline Characteristics

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Baseline characteristics by cohort

Measure	BMS-986165 6mg QD n=120 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=60 Participants Participants received placebo daily (QD)	Total n=180 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	36 Participants n=7 Participants	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	108 Participants n=5 Participants	50 Participants n=7 Participants	158 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	49.1 Years STANDARD_DEVIATION 14.92 • n=5 Participants	47.5 Years STANDARD_DEVIATION 13.55 • n=7 Participants	48.6 Years STANDARD_DEVIATION 14.46 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	20 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	40 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	22 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)

Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey 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 4-point scale:

0=not at all

1. a little

2. a lot

3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.

Outcome measures

Measure	BMS-986165 6mg QD n=120 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=60 Participants Participants received placebo daily (QD)
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Full Analysis Set	33.3 Percentage of Participants Interval 25.0 to 42.5	6.7 Percentage of Participants Interval 1.8 to 16.2
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Full Analysis Set Sub-population	32.7 Percentage of Participants Interval 24.0 to 42.5	6.1 Percentage of Participants Interval 1.3 to 16.9

SECONDARY outcome

Timeframe: At Week 16

Population: Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)

The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment.

The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3:

0 = Not at all

1. = A little

2. = A lot

3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.

Outcome measures

Measure	BMS-986165 6mg QD n=120 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=60 Participants Participants received placebo daily (QD)
Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Full Analysis Set Sub-population	72.9 Percentage of Participants Interval 63.4 to 81.0	53.1 Percentage of Participants Interval 38.3 to 67.5
Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Full Analysis Set	72.5 Percentage of Participants Interval 63.6 to 80.3	53.3 Percentage of Participants Interval 40.0 to 66.3

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: Full Analysis Set: Randomized Participants Full Analysis Set Sub-Population: Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)

The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching.

Outcome measures

Measure	BMS-986165 6mg QD n=120 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 Full Analysis Set	-3.8 Score on a Scale Standard Deviation 2.86	-1.8 Score on a Scale Standard Deviation 2.78
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 Full Analysis Set Sub-population	-3.8 Score on a Scale Standard Deviation 2.73	-1.8 Score on a Scale Standard Deviation 2.70

SECONDARY outcome

Timeframe: At Week 16

Population: All randomized participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)

The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis.

Outcome measures

Measure	BMS-986165 6mg QD n=107 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=49 Participants Participants received placebo daily (QD)
Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16	35.5 Percentage of Participants Interval 26.5 to 45.4	8.2 Percentage of Participants Interval 2.3 to 19.6

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	BMS-986165 6mg QD n=119 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16	63 Participants	25 Participants

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Measure	BMS-986165 6mg QD n=119 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.

ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal

Outcome measures

Measure	BMS-986165 6mg QD n=119 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 ALT or AST > 5 X ULN	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 ALT or AST > 3 X ULN and Total Bilirubin > 2 X ULN on the same day	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 ALT or AST > 3 X ULN	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 Total Bilirubin > 2 X ULN	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.

Outcome measures

Measure	BMS-986165 6mg QD n=119 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 Hematology: Leukocytes (Grade 3)	1 Participants	0 Participants
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 Hematology: Platelets (Grade 4)	1 Participants	0 Participants
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 Chemistry: Potassium (Grade 3)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.

Outcome measures

Measure	BMS-986165 6mg QD n=118 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=58 Participants Participants received placebo daily (QD)
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Heart Rate (Beats/Min): Value < 55 And Change From Baseline < -15	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Heart Rate (Beats/Min): Not Reported	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Systolic Blood Pressure (Mmhg): Value < 90 And Change From Baseline < -20	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Heart Rate (Beats/Min): Value > 100 And Change From Baseline > 30	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Systolic Blood Pressure (Mmhg): Value > 140 And Change From Baseline > 20	5 Participants	4 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Systolic Blood Pressure (Mmhg): Not Reported	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Diastolic Blood Pressure (Mmhg): Value > 90 And Change From Baseline > 10	19 Participants	6 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Diastolic Blood Pressure (Mmhg): Value < 55 And Change From Baseline < -10	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 Diastolic Blood Pressure (Mmhg): Not Reported	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Week 0 through Week 16

Population: As-treated Population

Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min).

Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.

Outcome measures

Measure	BMS-986165 6mg QD n=119 Participants Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 Participants Participants received placebo daily (QD)
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16	0 Participants	0 Participants

Adverse Events

BMS-986165 6mg QD

Serious events: 3 serious events

Other events: 32 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	BMS-986165 6mg QD n=119 participants at risk Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 participants at risk Participants received placebo daily (QD)
Cardiac disorders Angina pectoris	0.00% 0/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	1.7% 1/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Ear and labyrinth disorders Vertigo positional	0.84% 1/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	0.00% 0/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
General disorders Death	0.84% 1/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	0.00% 0/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Infections and infestations Pyelonephritis	0.84% 1/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	0.00% 0/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.

Other adverse events

Measure	BMS-986165 6mg QD n=119 participants at risk Participants received deucravacitinib at a dose of 6 mg daily (QD)	Placebo n=59 participants at risk Participants received placebo daily (QD)
Infections and infestations COVID-19	5.9% 7/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	3.4% 2/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Infections and infestations Nasopharyngitis	6.7% 8/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	3.4% 2/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Infections and infestations Sinusitis	5.0% 6/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	0.00% 0/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Infections and infestations Upper respiratory tract infection	3.4% 4/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	5.1% 3/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Nervous system disorders Headache	1.7% 2/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	5.1% 3/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.84% 1/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	5.1% 3/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Skin and subcutaneous tissue disorders Acne	7.6% 9/119 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.	0.00% 0/59 • Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 20 months. All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

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