PsoriasisPhase 4ARTISTYKNCT05701995

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

A Phase 4 study testing Deucravacitinib in people with Psoriasis, run by Bristol-Myers Squibb at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Deucravacitinib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 38 sitesin 2 countries
Study dates: 31 Jan 2023to 29 May 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1

Who cannot join

Target Disease Exceptions:
Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1
Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States35 sites

Local Institution - 0037
Atlanta, Georgia, 30331
Local Institution - 0010
Auburn Hills, Michigan, 48326
Local Institution - 0004
Bakersfield, California, 93309
Local Institution - 0003
Baton Rouge, Louisiana, 70809
Local Institution - 0021
Bellevue, Washington, 98004
Local Institution - 0005
Bexley, Ohio, 43209
Local Institution - 0027
Brandon, Florida, 33511
Local Institution - 0030
Centennial, Colorado, 80111
Local Institution - 0019
Charleston, South Carolina, 29407
Local Institution - 0016
Coral Gables, Florida, 33134
Local Institution - 0029
Cypress, Texas, 77433
Local Institution - 0028
Frisco, Texas, 75034
Local Institution - 0017
Las Vegas, Nevada, 89148
Local Institution - 0012
Mayfield Heights, Ohio, 44124
Local Institution - 0031
Mill Creek, Washington, 98012
Local Institution - 0032
New York, New York, 10011
Local Institution - 0013
New York, New York, 10128
Local Institution - 0015
North Little Rock, Arkansas, 72117
Riverchase Dermatology
Pembroke Pines, Florida, 33028
Local Institution - 0006
Phoenix, Arizona, 85006
Local Institution - 0035
Reno, Nevada, 89509
Local Institution - 0001
Rochester, New York, 14623
Local Institution - 0018
Rockville, Maryland, 20850
Local Institution - 0007
Rolling Meadows, Illinois, 60008
Local Institution - 0009
Sacramento, California, 95815
Local Institution - 0022
San Diego, California, 92103
Local Institution - 0034
Scottsdale, Arizona, 85260
Local Institution - 0025
Skokie, Illinois, 60077
Local Institution - 0020
Snellville, Georgia, 30078
Local Institution - 0008
South Jordan, Utah, 84095
Local Institution - 0014
Spokane, Washington, 99202
Local Institution - 0036
Springfield, Illinois, 62703
Local Institution - 0033
Springville, Utah, 84663
Local Institution - 0024
Washington D.C., District of Columbia, 20016
Local Institution - 0002
Waterford, Michigan, 48328

Other trials in United States

Puerto Rico3 sites

Local Institution - 0040
Caguas, 00727
Local Institution - 0038
Carolina, 00985
Local Institution - 0039
San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Conditions: Psoriasis
Being tested: Deucravacitinib, Placebo
Keywords: plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeucravacitinibDrug
Also called BMS-986165, Sotyktu
Specified dose on specified days.
PlaceboOther
Specified dose on specified days.

Study groups in NCT05701995
Study group	Role	What they receive
Deucravacitinib	Experimental	Not described Receives: Drug: Deucravacitinib
Placebo then Deucravacitinib	Placebo comparator	Not described Receives: Drug: Deucravacitinib; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
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.
Measured: At Week 16

Secondary outcomes (9)

Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
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.
Measured: At Week 16
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16
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.
Measured: Baseline and at Week 16
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
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.
Measured: At Week 16
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16
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.
Measured: From Week 0 through Week 16
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16
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.
Measured: From Week 0 through Week 16
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.
ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal
Measured: From Week 0 through Week 16
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16
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.
Measured: From Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Measured: From Week 0 through Week 16
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16
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.
Measured: From Week 0 through Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202329 May 2025

First posted27 Jan 2023
Study start31 Jan 2023
Primary completion23 Aug 2024
Study completion29 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05701995
Sponsor's protocol ID: IM011-237
Other IDs: U1111-1276-5158
Acronym: ARTISTYK
Status last verified: May 2026
First submitted: 16 Jan 2023
Last updated: 3 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Moderate to Severe Psoriatic Arthritis
Recruiting
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
ClinicalTrials.gov ID: NCT05701995
Acronym / sponsor ID: ARTISTYK / IM011-237
Conditions: Psoriasis
Keywords: plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 31 Jan 2023 (actual)
Primary completion: 23 Aug 2024 (actual)
Study completion: 29 May 2025 (actual)
First posted: 27 Jan 2023 (actual)
Results: Posted 10 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Deucravacitinib	Experimental	Drug: Deucravacitinib
Placebo then Deucravacitinib	Placebo comparator	Drug: Deucravacitinib, Other: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1

Key exclusion criteria (3 listed)

Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1
Other protocol-defined inclusion/exclusion criteria apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DeucravacitinibAlso: BMS-986165, SotyktuSpecified dose on specified days.	Drug	Deucravacitinib, Placebo then Deucravacitinib
PlaceboSpecified dose on specified days.	Other	Placebo then Deucravacitinib

Primary outcome

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Time frame: At Week 16
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.

9 secondary outcomes

Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time frame: At Week 16
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16
Time frame: Baseline and at Week 16
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
Time frame: At Week 16
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16
Time frame: From Week 0 through Week 16
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16
Time frame: From Week 0 through Week 16
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16
Time frame: From Week 0 through Week 16
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16
Time frame: From Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16
Time frame: From Week 0 through Week 16
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16
Time frame: From Week 0 through Week 16

Results and safety

Results posted to the registry on 10 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deucravacitinib	120	119
Placebo	60	59

Primary outcome: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

Time frame: At Week 16. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Deucravacitinib n = 120	Placebo n = 60
Full Analysis Set	33.3 (25.0 to 42.5)	6.7 (1.8 to 16.2)
Full Analysis Set Sub-population	32.7 (24.0 to 42.5)	6.1 (1.3 to 16.9)

Deucravacitinib vs Placebo: Odds Ratio (OR): 7.7 (95% CI 2.5 to 23.6), p = 0.0001, Stratified Cochran-Mantel-Haenszel (CMH)
Deucravacitinib vs Placebo: Odds Ratio (OR): 8.5 (95% CI 2.4 to 30.4), p = 0.0003, Stratified Cochran-Mantel-Haenszel (CMH)

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

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 28 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Controlled - Deucravacitinib	3 of 119 (2.5%)	32 of 119 (26.9%)	1 of 119
Placebo Controlled - Placebo	1 of 59 (1.7%)	13 of 59 (22%)	0 of 59
Active Treatment - Deucravacitinib - Deucravacitinib	5 of 103 (4.9%)	26 of 103 (25.2%)	1 of 103
Active Treatment - Placebo - Deucravacitinib	3 of 49 (6.1%)	10 of 49 (20.4%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
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Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

38 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Deucravacitinib in people with Psoriasis, run by Bristol-Myers Squibb at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.