Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Psoriasis Clinical Trial

— POETYK-PSO-1  

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study 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: NCT03624127
• Other study ID #: IM011-046
• Secondary ID: 2018-001926-25
• Status: Completed
• Phase: Phase 3
• Start date: August 7, 2018
• Est. completion date: September 2, 2020

Study information

• Verified date: January 2023
• 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: 666
• Est. completion date: September 2, 2020
• Est. primary completion date: September 2, 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 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
Canada	Kirk Barber Research	Calgary	Alberta
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Docteur David Gratton Dermatologue	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	Office of Dr. Arnon Moshe Katz	Newmarket	Ontario
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Institute of Cosmetic and Laser Surgery	Oakville	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec Metropolitain	Quebec
Canada	The Centre for Dermatology - Richmond Hill	Richmond Hill	Ontario
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	XLR8 Medical Research	Windsor	Ontario
Canada	Wiseman Dermatology Research	Winnipeg	Manitoba
China	Local Institution	Beijing	Beijing
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Wuhan	Hubei
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Local Institution - 0182	Isehara City	Kanagawa
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital	Itabashi-Ku	Tokyo
Japan	University of Occupational and Environmental Health, Japan	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital - Kyoto Preferctural University of Medicine	Kyoto-city	Kyoto
Japan	Local Institution - 0166	Matsumoto	Nagano
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Local Institution - 0165	Nagoya	Aichi
Japan	Kochi Medical School Hospital	Nakoku	Kochi
Japan	Local Institution - 0160	Osaka
Japan	Local Institution - 0167	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Local Institution - 0188	Shinagawa	Tokyo
Japan	Local Institution - 0108	Shinjuku	Tokyo
Japan	Local Institution - 0175	Shinjuku-Ku	Tokyo
Japan	Local Institution - 0181	Toon-Shi	Ehime
Japan	Mie University Hospital	Tsu	MIE
Japan	Local Institution - 0169	Yokohama	Kanagawa
Japan	National Hospital Organization Yokohama Medical Center	Yokohama-shi	Kanagawa
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Hwaseong-si
Korea, Republic of	Local Institution - 0187	Hwaseong-si
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seongnam-si
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Poland	Local Institution - 0201	Bialystok
Poland	Local Institution - 0144	Gdynia
Poland	Synexus - Katowice	Katowice
Poland	Local Institution - 0079	Krak
Poland	Centrum Medyczne All-Med	Lodz
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Miejski Szpital Zespolony w Olsztynie	Olsztyn
Poland	DermoDent - Centrum Medyczne Czajkowscy	Osielsko
Poland	Local Institution - 0200	Poznan
Poland	Solumed Centrum Medyczne	Poznan
Poland	Clinical Research Group	Warszawa
Poland	Local Institution - 0191	Warszawa	MZ
Poland	Center for Clinical Studies - Texas Medical Center	Wroclaw
Poland	dermMedica Sp. z o.o.	Wroclaw
Poland	Local Institution - 0203	Wroclaw
Poland	Lukasz Matusiak 4health	Wroclaw
Russian Federation	Local Institution - 0131	Ekaterinburg
Russian Federation	Azbuka Zdorovya Medical Center	Kazan
Russian Federation	Local Institution - 0172	Krasnodar
Russian Federation	Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov	Moscow
Russian Federation	Local Institution - 0140	Moscow
Russian Federation	State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary	Ryazan
Russian Federation	Ars Vitae Multidisciplinary Medical Center	Saint Petersburg
Russian Federation	Clinic of Skin Diseases of Pierre Wolkenstein	Saint Petersburg
Russian Federation	Polyclinic of Private Security Personnel	Saint Petersburg
Russian Federation	Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology	Saint Petersburg
Russian Federation	Klinika Kozhnykh I Venericheskikh Bolezney	Saratov
Russian Federation	Smolensk State Medical University	Smolensk
Russian Federation	MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev	Yaroslavl
Spain	Local Institution - 0121	Alcorcon
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Universitario Cruces	Barakaldo
Spain	Hospital del Mar - Parc de Salut Mar	Barcelona
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Local Institution - 0097	Valencia
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
United Kingdom	MAC Clinical Research - Blackpool	Lancashire
United Kingdom	Synexus - Merseyside Clinical Research Centre	Liverpool
United Kingdom	Guys and Saint Thomas NHS Foundation Trust	London
United Kingdom	Salford Royal NHS Foundation Trust	Manchester
United Kingdom	Synexus - Manchester Clinical Research Centre	Manchester
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	MAC Clinical Research - Liverpool	Prescot
United States	Hamilton Dermatology	Alpharetta	Georgia
United States	Synexus Clinical Research - Anderson	Anderson	South Carolina
United States	David Fivenson MD Dermatology	Ann Arbor	Michigan
United States	Westlake Dermatology - Westlake	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	ActivMed Practices and Research - Beverly	Beverly	Massachusetts
United States	Achieve Clinical Research	Birmingham	Alabama
United States	New England Research Associates	Bridgeport	Connecticut
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Synexus - Columbus	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Precision Clinical Research	Davie	Florida
United States	Duke University Health System - Duke Clinic	Durham	North Carolina
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Healthcare Research Network - Flossmoor	Flossmoor	Illinois
United States	First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley	Fountain Valley	California
United States	Indago Research and Health Center	Hialeah	Florida
United States	University California at Irvine Dermatology Clinical Research Center	Irvine	California
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Keck School of Medicine	Los Angeles	California
United States	Dermatology Specialists Research-Kentucky	Louisville	Kentucky
United States	International Dermatology Research	Miami	Florida
United States	LCC Medical Research	Miami	Florida
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	Well Pharma Medical Research	Miami	Florida
United States	San Marcus Research Clinic	Miami Lakes	Florida
United States	Coastal Clinical Research - Mobile	Mobile	Alabama
United States	Clinical Trials of America - Monroe	Monroe	Louisiana
United States	Interspond - Stones River Dermatology - Murfreesboro Office	Murfreesboro	Tennessee
United States	The Dermatology Center	New Albany	Indiana
United States	Associated Skin Care Specialists - Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Etre Cosmetic Dermatology and Laser Center	New Orleans	Louisiana
United States	Mount Sinai - Queens	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Ameriderm Research	Ormond Beach	Florida
United States	Kansas City Dermatology	Overland Park	Kansas
United States	Austin Institute for Clinical Research - Pflugerville	Pflugerville	Texas
United States	Arizona Research Center	Phoenix	Arizona
United States	Elite Clinical Studies	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Dream Team Clinical Research	Pomona	California
United States	Oregon Medical Research Center	Portland	Oregon
United States	DermCare Experts	Quincy	Massachusetts
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Hull Dermatology	Rogers	Arkansas
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University Dermatology Group	San Diego	California
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	Unison Clinical Trials	Sherman Oaks	California
United States	The South Bend Clinic	South Bend	Indiana
United States	Springfield Clinic	Springfield	Illinois
United States	Interspond - Acclaim Dermatology	Sugar Land	Texas
United States	Olympian Clinical Research	Tampa	Florida
United States	Somerset Skin Centre	Troy	Michigan
United States	Synexus - Tucson	Tucson	Arizona
United States	Eastern Washington Dermatology	Walla Walla	Washington
United States	Center for Clinical Studies - Webster	Webster	Texas
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Clinical Research Center of Reading	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  China,  Germany,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  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 of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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)	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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 16
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)	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 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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 16
Secondary	The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)	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 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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 16
Secondary	The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). 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 that 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 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16	PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data.; Baseline is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 16
Secondary	Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16	PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1.	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)	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 before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (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 response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score >=2.	Week 16
Secondary	Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16	PGA-F overall condition of the fingernails 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.	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)	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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 16
Secondary	The Number of Participants With a Static Physician's 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 of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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 Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (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 that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score >=3.	Week 16
Secondary	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1)	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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 Apremilast at Week 24 (PASI 75)	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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 24
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)	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 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 that 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 is defined as the measurement at the randomization visit (Week 0).	Baseline and Week 24
Secondary	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1)	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.	Week 52 and 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 Apremilast at Week 52 and at Week 24 (PASI 75)	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 that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.; Baseline is defined as the measurement at the randomization visit (Week 0).	Baseline, Week 52 and Week 24
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90)	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 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 that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason.; Baseline is defined as the measurement at the randomization visit (Week 0).	Baseline, Week 52 and Week 24

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls