PsoriasisPhase 3NCT03924427

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis

A Phase 3 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 27 sites in Japan.

Completed

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

Trial summary

The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Psoriasis
What is being tested?: BMS-986165
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 27 sitesJapan
Study dates: 10 Apr 2019to 24 Mar 2021
Phase: Phase 3
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

Who cannot join

Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
History of recent infection
Prior exposure to BMS-986165
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Japan27 sites

Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610
University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, 807-8555
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kumamoto University Hospital
Kumamoto, 860-8556
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 7108602
University Hospital - Kyoto Preferctural University of Medicine
Kyoto, Kyoto, 602-8566
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Local Institution - 0004
Matsumoto, Nagano, 3908621
The Jikei University Hospital
Minato-ku, Tokyo, 105-8471
Local Institution
Morioka, Iwate, 0208505
Local Institution - 0014
Nagoya, Aichi-ken, 467-8602
Kochi Medical School Hospital
Nakoku, Kochi, 783-8505
Local Institution - 0003
Osaka, 545-8586
Local Institution - 0012
Osaka, 550-0006
Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
NTT Medical Center Tokyo
Shinagawa, Tokyo, 141-8625
Japan Community Health Care Organization Tokyo Yamate Medical Center
Shinjuku, Tokyo, 169-0073
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 1600023
Teikyo University Hospital
tabashi City, Tokyo, 173-8605
Local Institution
Toon-Shi, Ehime, 791-0295
Mie University Hospital
Tsu, Mie-ken, 514-8507
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 2458575

Other trials in Japan

About this study

Official title: An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis

The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.

Conditions: Psoriasis
Being tested: BMS-986165
Medical subject headings: Psoriasis

What participants receive

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

BMS-986165Drug
Oral tablet administration

Study groups in NCT03924427
Study group	Role	What they receive
BMS-986165	Experimental	Given daily Receives: Drug: BMS-986165

What is being measured

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

Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity:
- Clear (0)
- Almost clear (1)
- Mild (2)
- Moderate (3)
- Severe (4)
Measured: Week 16
Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method.
Measured: Week 16

Timeline

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

10 Apr 201924 Mar 2021

First posted23 Apr 2019
Study start10 Apr 2019
Primary completion24 Mar 2021
Study completion24 Mar 2021

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03924427
Sponsor's protocol ID: IM011-066
Status last verified: Oct 2022
First submitted: 16 Apr 2019
Last updated: 2 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Okubo Y, Morita A, Imafuku S, Tada Y, Tsuritani K, Shao Y, Popmihajlov Z, Napoli A, Hippeli L, Habiro K, Ohtsuki M. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Plaque Psoriasis: In-Depth Analysis of Efficacy and Safety in the Phase 3 POETYK PSO-4 Trial. J Dermatol. 2025 Jun;52(6):953-966. doi: 10.1111/1346-8138.17744. Epub 2025 Apr 30.
PubMed 40304108
Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.
PubMed 40066907

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

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis
Not yet recruiting
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
Nail Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis
ClinicalTrials.gov ID: NCT03924427
Acronym / sponsor ID: IM011-066
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 10 Apr 2019 (actual)
Primary completion: 24 Mar 2021 (actual)
Study completion: 24 Mar 2021 (actual)
First posted: 23 Apr 2019 (actual)
Results: Posted 2 Nov 2022

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 investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMS-986165	Experimental	Drug: BMS-986165Given daily

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

Key exclusion criteria (4 listed)

Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
History of recent infection
Prior exposure to BMS-986165
Other protocol defined inclusion/exclusion criteria could 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
BMS-986165Oral tablet administration	Drug	BMS-986165

Primary outcome

Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16
Time frame: Week 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity: * Clear (0) * Almost clear (1) * Mild (2) * Moderate (3) * Severe (4)
Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16
Time frame: Week 16
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method.

Results and safety

Results posted to the registry on 2 Nov 2022, 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 6 mg QD	74	68

Primary outcome: Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16

Time frame: Week 16. Count of participants. Unit: Participants

Measure	Plaque Psoriasis 6 mg QD n = 63	Generalized Pustular Psoriasis 6 mg QD n = 3	Erythrodemic Psoriasis 6 mg QD n = 8
Value	52	0	4

Population analysed: All treated participants

Primary outcome: Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16

Time frame: Week 16. Count of participants. Unit: Participants

Measure	Plaque Psoriasis 6 mg QD n = 63	Generalized Pustular Psoriasis 6 mg QD n = 3	Erythrodemic Psoriasis 6 mg QD n = 8
Value	48	2	3

Population analysed: All treated participants

Adverse events

Time frame: Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deucravacitinib 6 mg QD	5 of 74 (6.8%)	40 of 74 (54.1%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40304108Okubo Y, Morita A, Imafuku S, Tada Y, Tsuritani K, Shao Y, Popmihajlov Z, Napoli A, Hippeli L, Habiro K, Ohtsuki M. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Plaque Psoriasis: In-Depth Analysis of Efficacy and Safety in the Phase 3 POETYK PSO-4 Trial. J Dermatol. 2025 Jun;52(6):953-966. doi: 10.1111/1346-8138.17744. Epub 2025 Apr 30.
Derived from this study: PubMed 40066907Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Investigator Inquiry FormLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Psoriasis

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis
Not yet recruiting
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
Nail Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

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

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 27 sites in Japan.

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 1 inclusion and 4 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Nov 2022). 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?

Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16 (time frame: Week 16). The study lists 2 primary outcomes in all. 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 NCT03924427, which also lists 2 linked publications.

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 2 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.