An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Psoriasis Clinical Trial

— POETYK-PSO-2  

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611751
• Other study ID #: IM011-047
• Secondary ID: 2018-001925-24
• Status: Completed
• Phase: Phase 3
• Start date: July 26, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: November 30, 2020
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Plaque psoriasis for at least 6 months

• Moderate to severe disease

• Candidate for phototherapy or systemic therapy

Exclusion Criteria:

• Other forms of psoriasis

• History of recent infection

• Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Drug:
• Apremilast
Specified dose on specified days

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Skin and Cancer Foundation	Carlton	Victoria
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	North Eastern Health Specialists	Hectorville	South Australia
Australia	St. George Dermatology & Skin Care Centre	Kogarah	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Canada	CCA Medical Research	Ajax	Ontario
Canada	Institute for Skin Advancement	Calgary	Alberta
Canada	Dr. Isabelle Delorme	Drummondville	Quebec
Canada	Stratica Medical	Edmonton	Alberta
Canada	DermEffects	London	Ontario
Canada	Mediprobe Research	London	Ontario
Canada	Lynderm Research	Markham	Ontario
Canada	DermEdge	Mississauga	Ontario
Canada	York Dermatology Clinic and Research Centre	Mississauga	Ontario
Canada	Innovaderm Research	Montreal	Quebec
Canada	Office of Dr. Niakosari Firouzeh	North York	Ontario
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	Dermatology on Bloor	Toronto	Ontario
Canada	Toronto Dermatology Centre	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Kim Papp Clinical Research	Waterloo	Ontario
Czechia	Nemocnice Jihlava	Jihlava 1
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin
Czechia	MUDr. Helena Korandova	Olomouc
Czechia	Fakultni Nemocnice Ostrava	Ostrava
Czechia	Sanatorium profesora Arenbergera	Praha 1
Czechia	Clintrial	Praha 10
Czechia	Kozni a zilni ambulance	Usti nad Labem
Czechia	Krajska zdravotni - Masarykova nemocnice v Usti nad Labem	Usti nad Labem
Finland	Terveystalo Tampere	Tampere
Finland	Mehilainen Turku	Turku
Finland	Local Institution - 0197	Vaasa
France	Hopital Prive dAntony	Antony
France	Centre Hospitalier Regional Universitaire Brest Hopital Morvan	Brest Cedex
France	Centre Hospitalier Universitaire de Nice Hopital lArchet	Nice Cedex 3
France	Centre Hospitalier Universitaire de Toulouse- Hopital Larrey	Toulouse Cedex 9
Germany	Local Institution - 0128	Augsburg
Germany	Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus	Bochum
Germany	Hautarztpraxis Dr. Beatrice Gerlach	Dresden
Germany	Local Institution - 0246	Frankfurt am Main
Germany	Local Institution - 0119	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Dermakiel - Allergie Und Haut Centrum	Kiel
Germany	Praxis Dr. Beate Schwarz	Langenau
Germany	Universitatsklinikum Schleswig-Holstein - Campus Lubeck	Lubeck
Germany	Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog	Munchen
Germany	Harzklinikum Dorothea Christiane Erxleben	Quedlinburg
Germany	Praxis Dr. med. Wilfried Steinborn	Straubing
Germany	CentroDerm GmbH	Wuppertal
Hungary	Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Synexus Magyarorszag	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site	Debrecen
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula	Gyula
Hungary	Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat	Nyiregyhaza
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Allergo-Derm Bakos	Szolnok
Hungary	Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg	Zalaegerszeg
Israel	Local Institution	Haifa
Israel	Local Institution	Kfar Saba
Israel	Local Institution	Petah Tikva
Israel	Local Institution	Ramat Gan
Italy	Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi	Bologna
Italy	Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara	Pisa
New Zealand	Local Institution	Hamilton
New Zealand	Local Institution	Mount Cook
New Zealand	Local Institution	Tauranga
Poland	ClinicMed Daniluk Nowak Spolka Jawna	Bialystok
Poland	ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik	Bialystok
Poland	Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska	Elblag
Poland	Synexus Polska Oddzial w Gdansk	Gda?sk
Poland	Zespol Naukowo-Leczniczy Iwolang	Iwonicz-Zdroj
Poland	Krakowskie Centrum Medyczne	Krakow
Poland	Dermed Centrum Medyczne	Lodz
Poland	Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER	Lublin
Poland	ETG - Siedlce	Siedlce
Poland	ETG - Skierniewice	Skierniewice
Poland	Local Institution - 0142	Torun
Poland	Klinika Ambroziak	Warsaw
Poland	ETG - Warszawa	Warszawa
Poland	High-Med Przychodnia Specjalistyczna	Warszawa
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warszawa
Poland	Local Institution - 0183	Wroclaw
Puerto Rico	GCM Medical Group	San Juan
Spain	Local Institution - 0156	Cordoba
Spain	Hospital Universitario de Vinalopo	Elche
Spain	Hospital Universitario de Gran Canaria Doctor Negrin	Las Palmas de Gran Canaria
Spain	Hospital Universitario Virgen de la Victoria	M?a
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital de Manises	Manises
Spain	Local Institution - 0137	Pozuelo de Alarcon
Spain	Burbage Surgery	Santiago de Compostela
Spain	Consorci Hospital General Universitari de Valencia	Valencia
Sweden	Ladulaas Kliniska Studier	Boras
Sweden	Pharmasite - Helsingborg	Helsingborg
Sweden	ProbarE i Lund	Lund
Sweden	PharmaSite - Malmo	Malmo
Sweden	Karolinska Universitetssjukhuset	Solna
United Kingdom	MAC Clinical Research - Cannock	Cannock
United Kingdom	Ashgate Medical Practice	Chesterfield
United Kingdom	Local Institution - 0189	Chorley
United Kingdom	Mounts Bay Medical	Cornwall
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley
United Kingdom	MAC Clinical Research - Stockton	Durham
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	MAC Clinical Research - Manchester	Manchester
United States	Anaheim Clinical Trials	Anaheim	California
United States	Ora	Andover	Massachusetts
United States	A. Alfred Taubman Health Care Center	Ann Arbor	Michigan
United States	Arlington Center for Dermatology	Arlington	Texas
United States	DermResearch	Austin	Texas
United States	Bellaire Dermatology	Bellaire	Texas
United States	The Kirklin Clinic of UAB Hospital	Birmingham	Alabama
United States	Total Skin and Beauty Dermatology Center	Birmingham	Alabama
United States	Skin Care Research	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham Dermatology Associates	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Glazer Dermatology	Buffalo Grove	Illinois
United States	PMG Research of Cary	Cary	North Carolina
United States	Synexus - Cincinnati	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	ClinOhio Research Services	Columbus	Ohio
United States	Washington University School of Medicine - West County Dermatology	Creve Coeur	Missouri
United States	Dermatology Center of Northwest Indiana	Crown Point	Indiana
United States	Modern Research Associates	Dallas	Texas
United States	Synexus - Dallas	Dallas	Texas
United States	ERN - Accel Research - Avail	DeLand	Florida
United States	Windsor Dermatology	East Windsor	New Jersey
United States	Synexus - Evansville South	Evansville	Indiana
United States	Dermatology and Skin Surgery Center - Exton	Exton	Pennsylvania
United States	Wright State Research Institute	Fairborn	Ohio
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Associates in Research, Inc.	Fresno	California
United States	Rivergate Dermatology - Main Office	Goodlettsville	Tennessee
United States	Synexus	Greer	South Carolina
United States	Healthcare Research Network - Hazelwood	Hazelwood	Missouri
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Dawes Fretzin Dermatology Group	Indianapolis	Indiana
United States	Clinical Research Solutions - Jackson	Jackson	Tennessee
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Advanced Medical Research	Lacombe	Louisiana
United States	Shondra L. Smith, M.D.	Lake Charles	Louisiana
United States	Clinical Research Consortium - Las Vegas	Las Vegas	Nevada
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Interspond - Long Beach Clinical Trials	Long Beach	California
United States	Dermatology Research Associates - Los Angeles	Los Angeles	California
United States	LA Universal Research Center	Los Angeles	California
United States	Skin Sciences	Louisville	Kentucky
United States	Marietta Dermatology & The Skin Cancer Center	Marietta	Georgia
United States	Advanced Clinical Research - Idaho	Meridian	Idaho
United States	Interspond - Savin Medical Group	Miami Lakes	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Coastal Carolina Research Center - Mount Pleasant	Mount Pleasant	South Carolina
United States	DelRicht Research - New Orleans - Prytania Street	New Orleans	Louisiana
United States	Sadick Research Group	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Paddington Testing Company	Philadelphia	Pennsylvania
United States	Alliance Dermatology and Mohs Center - Phoenix	Phoenix	Arizona
United States	Synexus Clinical Research - Saint Petersburg	Pinellas Park	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	ActivMed Practices and Research - Portsmouth	Portsmouth	New Hampshire
United States	Health Concepts	Rapid City	South Dakota
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research - San Antonio	San Antonio	Texas
United States	Artemis Institute for Clinical Research - San Diego	San Diego	California
United States	Therapeutics Clinical Research	San Diego	California
United States	University of California San Diego Health Systems	San Diego	California
United States	San Luis Dermatology and Laser Clinic	San Luis Obispo	California
United States	Artemis Institute for Clinical Research - San Marcos	San Marcos	California
United States	West Coast Research	San Ramon	California
United States	Clinical Science Institute	Santa Monica	California
United States	Synexus - Santa Rosa	Santa Rosa	California
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	DermResearch Center of New York	Stony Brook	New York
United States	Interspond - Houston Center for Clinical Research	Sugar Land	Texas
United States	Precision Clinical Research - Corporate Office	Sunrise	Florida
United States	Precision Clinical Research - Corporate Office	Tamarac	Florida
United States	ForCare Clinical Research	Tampa	Florida
United States	Moore Clinical Research - South Tampa	Tampa	Florida
United States	University of South Florida/USF Health	Tampa	Florida
United States	Clinical Research Consortium - Tempe	Tempe	Arizona
United States	Care Access Research - Walnut Creek	Walnut Creek	California
United States	Dundee Dermatology	West Dundee	Illinois
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  New Zealand,  Poland,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Primary	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Baseline and Week 16
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Baseline and Week 16
Secondary	The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Baseline and Week 16
Secondary	The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Secondary	Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16	PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).; A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.	Baseline and Week 16
Secondary	Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16	Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.	Week 16
Secondary	The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score =3 .; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Secondary	The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score =2.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Secondary	The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)	The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Secondary	The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)	The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score = 3.	Week 16
Secondary	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Baseline and Week 16
Secondary	The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.	Week 16
Secondary	Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders	Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.; The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.	From Week 24 to Week 52 (up to approximately 28 weeks)
Secondary	The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.	Week 24
Secondary	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). 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. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.	Baseline and Week 24
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.; PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).; Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.	Baseline and week 24

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