PsoriasisPhase 2NCT02931838

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

A Phase 2 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 76 sites in 8 countries.

Completed

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

Trial summary

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165 Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Psoriasis
What is being tested?: BMS-986165
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 268 participants
Where: 76 sitesin 8 countries
Study dates: 15 Nov 2016to 16 Nov 2017
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female, ages 18 to 70 years
Diagnosis of plaque psoriasis for 6 months
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.

Who cannot join

Any significant acute or chronic medical illness
Blood transfusion within 4 weeks of study drug administration
Inability to tolerate oral medication
Positive hepatitis-B (HBV) surface antigen
Positive hepatitis-C (HCV) antibody
Any history or risk for tuberculosis (TB)

Show all 14Show fewer

Any major illness/condition or evidence of an unstable clinical condition
Chest X-ray findings suspicious of infection at screening
has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
Has received Rituximab within 6 months of first administration of study medication
Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

76 sites in 8 countries.

Country

City, postcode or hospital

76 sites in 8 countries

United States16 sites

Austin Dermatology Associates
Austin, Texas, 78705
PMG Research of Christie Clinic, LLC
Champaign, Illinois, 61820
Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
Charlotte, North Carolina, 28277
Rivergate Dermatology Clinical Research Center, Pllc
Goodlettsville, Tennessee, 37072
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
University of California Irvine
Irvine, California, 92697
Local Institution
Knoxville, Tennessee, 37920
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217
Central Sooner Research
Norman, Oklahoma, 73071
Renstar Medical Research
Ocala, Florida, 34471
Health Concepts
Rapid City, South Dakota, 57702
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804
University of California San Diego
San Diego, California, 92122
NorthShore University Health System
Skokie, Illinois, 60077
PMG Research of Wilmington, PLC
Wilmington, North Carolina, 28401

Other trials in United States

Japan13 sites

Local Institution
Fukuoka, Fukuoka, 814-0180
Local Institution
Kamigyō-ku, Kyoto, 602-8566
Local Institution
Kobe, Hyōgo, 6500017
Local Institution
Kumamoto, 8608556
Local Institution
Minato-ku, Tokyo, 105-8471
Local Institution
Nagoya, Aichi-ken, 4678602
Local Institution
Osaka, 5500012
Local Institution
Sapporo, Hokkaido, 060-0063
Local Institution
Shimotsuke-shi, Tochigi, 3290498
Local Institution
Shinagawa-Ku, Tokyo, 141-8625
Local Institution
Shinjuku-ku, Tokyo, 160-0023
Local Institution
Skinjuku-ku, Tokyo, 1690073
Local Institution
Tokyo, 1738606

Other trials in Japan

Poland13 sites

Local Institution
Krakow, 31-011
Local Institution
Lodz, 90-436
Local Institution
Lublin, 20-080
Local Institution
Osielsko, 86-031
Local Institution
Siedlce, 08 - 110
Local Institution
Skierniewice, 96-100
Local Institution
Warsaw, 00-660
Local Institution
Warsaw, 01-142
Local Institution
Warsaw, 01-817
Local Institution
Warsaw, 02-758
Local Institution
Warsaw, 02-777
Local Institution
Wroc?aw, 51-318
Local Institution
Wroclaw, 50368

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Canada11 sites

Local Institution
Calgary, Alberta, T2G 1B1
Local Institution
Edmonton, Alberta, T5K 1X3
Local Institution
Hamilton, Ontario, L8N 1Y2
Local Institution
Markham, Ontario, L3P 1X2
Local Institution
Mississauga, Ontario, L5H 1G9
Local Institution
Montreal, Quebec, H3H 1V4
Local Institution
Peterborough, Ontario, K9J 5K2
Local Institution
Toronto, Ontario, M4W 2N2
Local Institution
Vancouver, British Columbia, V5Z 4E8
Local Institution
Waterloo, Ontario, N2J 1C4
Local Institution
Windsor, Ontario, N8W 1E6

Other trials in Canada

Germany11 sites

Local Institution
Dresden, 01097
Local Institution
Gera, 07548
Local Institution
Hamburg, 20253
Local Institution
Hamburg, 20354
Local Institution
Kiel, 24103
Local Institution
Kiel, 24105
Local Institution
Lübeck, 23538
Local Institution
Mahlow, 15831
Local Institution
Mainz, 55131
Local Institution
Schwerin, 19055
Local Institution
Stuttgart, 70178

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Latvia6 sites

Local Institution
Daugavpils, LV-5404
Local Institution
Riga, LV-1001
Local Institution
Riga, LV-1003
Local Institution
Riga, LV-1011
Local Institution
Riga, LV-1013
Local Institution
Ventspils, LV3601

Other trials in Latvia

Australia4 sites

Local Institution
Kogarah, New South Wales, 2217
Local Institution
Melbourne, Victoria, 3053
Local Institution
Nedlands, Western Australia, 6009
Local Institution
Wolloongabba, Queensland, 4102

Other trials in Australia

Mexico2 sites

Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Zapopan, Jalisco, 45030

Other trials in Mexico

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Conditions: Psoriasis
Being tested: BMS-986165, Placebo for 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
Placebo for BMS-986165Drug

Study groups in NCT02931838
Study group	Role	What they receive
BMS-986165 Dose 1	Experimental	Specified dose of BMS-986165 on specified days. Receives: Drug: BMS-986165
BMS-986165 Dose 2	Experimental	Specified dose of BMS-986165 on specified days. Receives: Drug: BMS-986165
BMS-986165 Dose 3	Experimental	Specified dose of BMS-986165 on specified days. Receives: Drug: BMS-986165
BMS-986165 Dose 4	Experimental	Specified dose of BMS-986165 on specified days. Receives: Drug: BMS-986165
BMS-986165 Dose 5	Experimental	Specified dose of BMS-986165 on specified days. Receives: Drug: BMS-986165
Placebo	Placebo comparator	Specified dose of Placebo for BMS-986165 on specified days. Receives: Drug: Placebo for BMS-986165

What is being measured

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

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Measured: Day 1 to Day 85
Number of Participants With Adverse Events
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
Measured: Day 1 to day 115

Secondary outcomes (5)

Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Measured: Day 1 to Day 85
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Measured: Day 1 to Day 85
Change From Baseline in DLQI Scores on Day 85
The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
Measured: Day 1 to Day 85
Change From Baseline in BSA on Day 85
Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
Measured: Day 1 to Day 85
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Measured: Days 8, 15, 29, 57, 85

Timeline

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

15 Nov 201616 Nov 2017

First posted13 Oct 2016 (estimated)
Study start15 Nov 2016
Primary completion16 Nov 2017
Study completion16 Nov 2017

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 (4)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02931838
Sponsor's protocol ID: IM011-011
Status last verified: Oct 2020
First submitted: 3 Oct 2016
Last updated: 27 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG. Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial. Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16.
PubMed 39283417
Thaci D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatol Ther (Heidelb). 2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y. Epub 2022 Jan 13.
PubMed 35025062
Catlett IM, Hu Y, Gao L, Banerjee S, Gordon K, Krueger JG. Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. J Allergy Clin Immunol. 2022 Jun;149(6):2010-2020.e8. doi: 10.1016/j.jaci.2021.11.001. Epub 2021 Nov 10.
PubMed 34767869
Papp K, Gordon K, Thaci D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.
PubMed 30205746

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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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT02931838
Acronym / sponsor ID: IM011-011
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 15 Nov 2016 (actual)
Primary completion: 16 Nov 2017 (actual)
Study completion: 16 Nov 2017 (actual)
First posted: 13 Oct 2016 (estimated)
Results: Posted 27 Nov 2020

Clinical summary

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

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
BMS-986165 Dose 1	Experimental	Drug: BMS-986165Specified dose of BMS-986165 on specified days.
BMS-986165 Dose 2	Experimental	Drug: BMS-986165Specified dose of BMS-986165 on specified days.
BMS-986165 Dose 3	Experimental	Drug: BMS-986165Specified dose of BMS-986165 on specified days.
BMS-986165 Dose 4	Experimental	Drug: BMS-986165Specified dose of BMS-986165 on specified days.
BMS-986165 Dose 5	Experimental	Drug: BMS-986165Specified dose of BMS-986165 on specified days.
Placebo	Placebo comparator	Drug: Placebo for BMS-986165Specified dose of Placebo for BMS-986165 on specified days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female, ages 18 to 70 years
Diagnosis of plaque psoriasis for 6 months
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.

Key exclusion criteria (14 listed)

Any significant acute or chronic medical illness
Blood transfusion within 4 weeks of study drug administration
Inability to tolerate oral medication
Positive hepatitis-B (HBV) surface antigen
Positive hepatitis-C (HCV) antibody

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-986165	Drug	BMS-986165 Dose 1, BMS-986165 Dose 2, BMS-986165 Dose 3, BMS-986165 Dose 4, BMS-986165 Dose 5
Placebo for BMS-986165	Drug	Placebo

Primary outcome

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Time frame: Day 1 to Day 85
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Number of Participants With Adverse Events
Time frame: Day 1 to day 115
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation

5 secondary outcomes

Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Time frame: Day 1 to Day 85
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Time frame: Day 1 to Day 85
Change From Baseline in DLQI Scores on Day 85
Time frame: Day 1 to Day 85
Change From Baseline in BSA on Day 85
Time frame: Day 1 to Day 85
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Time frame: Days 8, 15, 29, 57, 85

Results and safety

Results posted to the registry on 27 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	45	31
BMS-986165 3MG QOD	44	34
BMS-986165 3MG QD	44	36
BMS-986165 3MG BID	45	42
BMS-986165 6MG BID	45	39
BMS-986165 12MG QD	44	42

Primary outcome: The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)

Time frame: Day 1 to Day 85. Number (95% Confidence Interval). Unit: Percentage

Measure	Placebo n = 45	BMS-986165 3MG QOD n = 44	BMS-986165 3MG QD n = 44	BMS-986165 3MG BID n = 45	BMS-986165 6MG BID n = 45	BMS-986165 12MG QD n = 44
Value	6.7 (1.4 to 18.3)	9.1 (2.5 to 21.7)	38.6 (24.4 to 54.5)	68.9 (53.4 to 81.8)	66.7 (51.0 to 80.0)	75.0 (59.7 to 86.8)

Placebo vs BMS-986165 3MG QOD: p = 0.4873, Chi-squared
Placebo vs BMS-986165 3MG QD: p = 0.0003, Chi-squared
Placebo vs BMS-986165 3MG BID: p <0.0001, Chi-squared

Population analysed: All Randomized and Treated Participants

Primary outcome: Number of Participants With Adverse Events

Time frame: Day 1 to day 115. Count of participants. Unit: Participants

Measure	Placebo n = 45	BMS-986165 3MG QOD n = 44	BMS-986165 3MG QD n = 44	BMS-986165 3MG BID n = 45	BMS-986165 6MG BID n = 45	BMS-986165 12MG QD n = 44
No. of participants with SAEs	1	1	1	1	0	0
No. of participants with AEs	24	26	25	29	36	34
No. of participants discontinued due to AEs	2	1	2	1	3	1

Population analysed: All Randomized and Treated Participants

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks (assessed up to November 16, 2017). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 45 (2.2%)	13 of 45 (28.9%)	0 of 45
BMS-986165 3mg QOD	1 of 44 (2.3%)	14 of 44 (31.8%)	0 of 44
BMS-986165 3mg QD	1 of 44 (2.3%)	18 of 44 (40.9%)	0 of 44
BMS-986165 3mg BID	1 of 45 (2.2%)	15 of 45 (33.3%)	0 of 45
BMS-986165 6mg BID	0 of 45 (0%)	25 of 45 (55.6%)	0 of 45
BMS-986165 12mg QD	0 of 44 (0%)	19 of 44 (43.2%)	0 of 44

Limitations and caveats (from the sponsor): The limitations of this phase 2 trial include its small sample size and short duration; these results warrant confirmation in a larger trial of longer duration

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39283417Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG. Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial. Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16.
Derived from this study: PubMed 35025062Thaci D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatol Ther (Heidelb). 2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y. Epub 2022 Jan 13.
Derived from this study: PubMed 34767869Catlett IM, Hu Y, Gao L, Banerjee S, Gordon K, Krueger JG. Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. J Allergy Clin Immunol. 2022 Jun;149(6):2010-2020.e8. doi: 10.1016/j.jaci.2021.11.001. Epub 2021 Nov 10.
Derived from this study: PubMed 30205746Papp K, Gordon K, Thaci D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.

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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

76 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 76 sites in 8 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 4 inclusion and 14 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Japan, Poland, Canada, Germany and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 27 Nov 2020). 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?

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12) (time frame: Day 1 to Day 85). 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 NCT02931838, which also lists 4 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 27 Nov 2020.