Psoriasis Clinical Trial
— POETYK-PSO-1Official 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
Verified date | January 2023 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Canada, China, Germany, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, United Kingdom,
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 |
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