Effectiveness and Safety of BMS-986165 Compared to Placeb... | NCT03624127 | Trialant
NCT03624127
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jan 30, 2023Actual
Enrollment
666Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
BMS-986165
Placebo
Apremilast
Countries
United States
Canada
China
Germany
Japan
Poland
Russia
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03624127
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-046
Secondary IDs
ID
Type
Description
Link
2018-001926-25
EudraCT Number
Brief Title
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
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
Acronym
POETYK-PSO-1
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jan 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 7, 2018Actual
Primary Completion Date
Sep 2, 2020Actual
Completion Date
Sep 2, 2020Actual
First Submitted Date
Aug 7, 2018
First Submission Date that Met QC Criteria
Aug 7, 2018
First Posted Date
Aug 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 6, 2022
Results First Submitted that Met QC Criteria
Jan 9, 2023
Results First Posted Date
Jan 30, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 1, 2021
Certification/Extension First Submitted that Passed QC Review
Jan 9, 2023
Certification/Extension First Posted Date
Jan 30, 2023Actual
Last Update Submitted Date
Jan 9, 2023
Last Update Posted Date
Jan 30, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
666Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BMS-986165
Experimental
Drug: BMS-986165
Placebo
Placebo Comparator
Other: Placebo
Apremilast
Active Comparator
Drug: Apremilast
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986165
Drug
Specified dose on specified days
BMS-986165
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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 Outcomes
Measure
Description
Time Frame
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Mobile
Alabama
36608
United States
Elite Clinical Studies
Phoenix
Arizona
85018
United States
Arizona Research Center
Phoenix
Arizona
85053
United States
Synexus - Tucson
Tucson
Arizona
85741
United States
Hull Dermatology
Rogers
Arkansas
72758
United States
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
Fountain Valley
California
92708
United States
University California at Irvine Dermatology Clinical Research Center
Irvine
California
92697
United States
Keck School of Medicine
Los Angeles
California
90033
United States
Dream Team Clinical Research
Pomona
California
91767
United States
University Dermatology Group
San Diego
California
92123
United States
Unison Clinical Trials
Sherman Oaks
California
91403
United States
New England Research Associates
Bridgeport
Connecticut
06606
United States
Precision Clinical Research
Davie
Florida
33328
United States
Indago Research and Health Center
Hialeah
Florida
33012
United States
LCC Medical Research
Miami
Florida
33126
United States
International Dermatology Research
Miami
Florida
33144
United States
Well Pharma Medical Research
Miami
Florida
33173
United States
Miami Dade Medical Research Institute
Miami
Florida
33176
United States
San Marcus Research Clinic
Miami Lakes
Florida
33014
United States
Renstar Medical Research
Ocala
Florida
34471
United States
Ameriderm Research
Ormond Beach
Florida
32174
United States
Olympian Clinical Research
Tampa
Florida
33614-7118
United States
Palm Beach Research Center
West Palm Beach
Florida
33409-3401
United States
Hamilton Dermatology
Alpharetta
Georgia
30022
United States
Healthcare Research Network - Flossmoor
Flossmoor
Illinois
60402
United States
Springfield Clinic
Springfield
Illinois
62703
United States
Deaconess Clinic Downtown
Evansville
Indiana
47708
United States
The Dermatology Center
New Albany
Indiana
47150
United States
The Indiana Clinical Trials Center
Plainfield
Indiana
46168
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
Kansas City Dermatology
Overland Park
Kansas
66215
United States
Dermatology Specialists Research-Kentucky
Louisville
Kentucky
40241
United States
Clinical Trials of America - Monroe
Monroe
Louisiana
71201
United States
Etre Cosmetic Dermatology and Laser Center
New Orleans
Louisiana
70130
United States
ActivMed Practices and Research - Beverly
Beverly
Massachusetts
01915
United States
DermCare Experts
Quincy
Massachusetts
02169
United States
David Fivenson MD Dermatology
Ann Arbor
Michigan
48103
United States
Somerset Skin Centre
Troy
Michigan
48084
United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton
Minnesota
55112
United States
MediSearch Clinical Trials
Saint Joseph
Missouri
64506
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Hassman Research Institute
Berlin
New Jersey
08009
United States
Forest Hills Dermatology Group
Kew Gardens
New York
11374
United States
Mount Sinai - Queens
New York
New York
10023
United States
PMG Research of Charlotte
Charlotte
North Carolina
28209
United States
Duke University Health System - Duke Clinic
Durham
North Carolina
27710-4000
United States
M3 Wake Research, Inc.
Raleigh
North Carolina
27612
United States
The Ohio State University Wexner Medical Center
Columbus
Ohio
43203
United States
Synexus - Columbus
Columbus
Ohio
43212
United States
Health Research of Oklahoma
Oklahoma City
Oklahoma
73103-2433
United States
Oregon Medical Research Center
Portland
Oregon
97223-6683
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Clinical Research Center of Reading
Wyomissing
Pennsylvania
19610
United States
Synexus Clinical Research - Anderson
Anderson
South Carolina
29621
United States
Clinical Research Center of the Carolinas
Charleston
South Carolina
29407
United States
Interspond - Stones River Dermatology - Murfreesboro Office
Murfreesboro
Tennessee
37129
United States
Westlake Dermatology - Westlake
Austin
Texas
78746
United States
Dermatology Treatment and Research Center
Dallas
Texas
75230
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
Menter Dermatology Research Institute
Dallas
Texas
75246
United States
Austin Institute for Clinical Research - Pflugerville
Pflugerville
Texas
78660
United States
University of Texas Health Science Center at San Antonio
San Antonio
Texas
78218
United States
Interspond - Acclaim Dermatology
Sugar Land
Texas
77479
United States
Center for Clinical Studies - Webster
Webster
Texas
77598
United States
Dermatology Associates of Seattle
Seattle
Washington
98101
United States
Eastern Washington Dermatology
Walla Walla
Washington
99362
United States
Kirk Barber Research
Calgary
Alberta
T2G 1B1
Canada
Dr. Chih-ho Hong Medical Inc.
Surrey
British Columbia
V3R 6A7
Canada
Wiseman Dermatology Research
Winnipeg
Manitoba
R3M 3Z4
Canada
The Guenther Dermatology Research Centre
London
Ontario
N6A 3H7
Canada
Office of Dr. Arnon Moshe Katz
Newmarket
Ontario
L3Y 6P5
Canada
North Bay Dermatology Centre
North Bay
Ontario
P1B 3Z7
Canada
Institute of Cosmetic and Laser Surgery
Oakville
Ontario
L6J 7W5
Canada
Skin Centre for Dermatology
Peterborough
Ontario
K9J 5K2
Canada
The Centre for Dermatology - Richmond Hill
Richmond Hill
Ontario
L4B 1A5
Canada
XLR8 Medical Research
Windsor
Ontario
N8W 1E6
Canada
Docteur David Gratton Dermatologue
Montreal
Quebec
H3H 1V4
Canada
Siena Medical Research
Montreal
Quebec
H3Z 2S6
Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec
Quebec
G1V 4X7
Canada
Local Institution
Beijing
Beijing Municipality
100050
China
Local Institution
Wuhan
Hubei
430030
China
Local Institution
Hangzhou
Zhejiang
310009
China
Charite Universitatsmedizin Berlin
Berlin
10117
Germany
Klinische Forschung Dresden GmbH
Dresden
01069
Germany
Local Institution - 0165
Nagoya
Aichi-ken
467-8602
Japan
Local Institution - 0181
Toon-Shi
Ehime
7910295
Japan
Fukuoka University Hospital
Fukuoka
Fukuoka
814-0180
Japan
University of Occupational and Environmental Health, Japan
Kitakyushu
Fukuoka
807-8555
Japan
Sapporo Skin Clinic
Sapporo
Hokkaido
060-0063
Japan
Kobe University Hospital
Kobe
Hyōgo
650-0017
Japan
Local Institution - 0182
Isehara
Kanagawa
259-1193
Japan
Local Institution - 0169
Yokohama
Kanagawa
236-0004
Japan
National Hospital Organization Yokohama Medical Center
Yokohama
Kanagawa
2458575
Japan
Kochi Medical School Hospital
Nakoku
Kochi
783-8505
Japan
University Hospital - Kyoto Preferctural University of Medicine
Kyoto
Kyoto
602-8566
Japan
Mie University Hospital
Tsu
Mie-ken
514-8507
Japan
Local Institution - 0166
Matsumoto
Nagano
3908621
Japan
Kurashiki Central Hospital
Kurashiki
Okayama-ken
7108602
Japan
Hamamatsu University Hospital
Hamamatsu
Shizuoka
431-3192
Japan
Jichi Medical University Hospital
Shimotsuke
Tochigi
329-0498
Japan
Teikyo University Hospital
Itabashi-Ku
Tokyo
173-8606
Japan
Nihon University Itabashi Hospital
Itabashi-ku
Tokyo
173-8610
Japan
The Jikei University Hospital
Minato-ku
Tokyo
105-8471
Japan
Local Institution - 0188
Shinagawa
Tokyo
141-8625
Japan
Local Institution - 0108
Shinjuku
Tokyo
169-0073
Japan
Local Institution - 0175
Shinjuku-Ku
Tokyo
160-0023
Japan
Kumamoto University Hospital
Kumamoto
860-8556
Japan
Kyoto University Hospital
Kyoto
606-8507
Japan
Local Institution - 0167
Osaka
545-8586
Japan
Local Institution - 0160
Osaka
550-0006
Japan
Local Institution - 0191
Warsaw
Masovian Voivodeship
02-962
Poland
Local Institution - 0201
Bialystok
15-077
Poland
Local Institution - 0144
Gdynia
81-537
Poland
Synexus - Katowice
Katowice
40-040
Poland
Local Institution - 0079
Krak
30-510
Poland
Centrum Terapii Wspolczesnej
Lodz
90-242
Poland
Centrum Medyczne All-Med
Lodz
94-048
Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn
10-229
Poland
DermoDent - Centrum Medyczne Czajkowscy
Osielsko
86-031
Poland
Solumed Centrum Medyczne
Poznan
60-529
Poland
Local Institution - 0200
Poznan
60-773
Poland
Clinical Research Group
Warsaw
01-142
Poland
Center for Clinical Studies - Texas Medical Center
Wroclaw
50-367
Poland
Lukasz Matusiak 4health
Wroclaw
50-566
Poland
dermMedica Sp. z o.o.
Wroclaw
51-318
Poland
Local Institution - 0203
Wroclaw
51-685
Poland
Azbuka Zdorovya Medical Center
Kazan'
42011
Russia
Local Institution - 0172
Krasnodar
350020
Russia
Local Institution - 0140
Moscow
101000
Russia
Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
Moscow
111398
Russia
State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
Ryazan
390046
Russia
Clinic of Skin Diseases of Pierre Wolkenstein
Saint Petersburg
191123
Russia
Polyclinic of Private Security Personnel
Saint Petersburg
192007
Russia
Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
Saint Petersburg
194021
Russia
Ars Vitae Multidisciplinary Medical Center
Saint Petersburg
194223
Russia
Klinika Kozhnykh I Venericheskikh Bolezney
Saratov
410028
Russia
Smolensk State Medical University
Smolensk
214019
Russia
MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
Yaroslavl
150003
Russia
Local Institution - 0131
Yekaterinburg
620076
Russia
Local Institution
Busan
49241
South Korea
Local Institution - 0187
Hwaseong-si
18450
South Korea
Local Institution
Hwaseong-si
18450
South Korea
Local Institution
Incheon
21565
South Korea
Local Institution
Seongnam-si
13620
South Korea
Local Institution
Seoul
120-752
South Korea
Local Institution
Seoul
137-701
South Korea
Local Institution
Seoul
660-702
South Korea
Local Institution - 0121
Alcorcón
28921
Spain
Hospital Universitari Germans Trias i Pujol
Badalona
08916
Spain
Hospital Universitario Cruces
Barakaldo
48903
Spain
Hospital del Mar - Parc de Salut Mar
Barcelona
08003
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Hospital Universitario de Fuenlabrada
Madrid
28942
Spain
Local Institution - 0097
Valencia
46026
Spain
Local Institution
Kaohsiung City
81362
Taiwan
Local Institution
Taipei
10099
Taiwan
Local Institution
Taipei
11217
Taiwan
MAC Clinical Research - Blackpool
Lancashire
FY2 0JH
United Kingdom
Synexus - Merseyside Clinical Research Centre
Liverpool
L22 0LG
United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London
SE1 9RT
United Kingdom
Synexus - Manchester Clinical Research Centre
Manchester
M15 6SE
United Kingdom
Salford Royal NHS Foundation Trust
Manchester
M6 8HD
United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.
Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.
Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.
Armstrong AW, Park SH, Patel V, Nicolas P, Wang WJ, Colombo MJ, Chirikov V. Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1891-1899. doi: 10.1007/s13555-024-01201-4. Epub 2024 Jun 22.
Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaci D, Morita A, Szepietowski JC, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary. Immunotherapy. 2023 Aug;15(12):963-973. doi: 10.2217/imt-2023-0061. Epub 2023 May 7.
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
FG002
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
FG000332 subjects
FG001166 subjects
FG002168 subjects
COMPLETED
Completed = Entered treatment period
FG000332 subjects
FG001165 subjects
FG002168 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Participant discontinued from study prior to treatment due to incorrect randomization
FG0000 subjects
FG0011 subjects
FG0020 subjects
Treatment Week 0 - Week 16
Type
Comment
Milestone Data
STARTED
FG000332 subjects
FG001165 subjects
FG002168 subjects
COMPLETED
FG000307 subjects
FG001145 subjects
FG002145 subjects
NOT COMPLETED
FG00025 subjects
FG00120 subjects
FG00223 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0017 subjects
FG00210 subjects
Death
FG000
Treatment Week 16 - Week 24
Type
Comment
Milestone Data
STARTED
FG000452 subjects
FG0010 subjects
FG002145 subjects
COMPLETED
FG000442 subjects
FG0010 subjects
FG002141 subjects
NOT COMPLETED
FG00010 subjects
FG0010 subjects
FG0024 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
Lack of Efficacy
FG000
Treatment Week 24 - Week 52
Type
Comment
Milestone Data
STARTED
FG000496 subjects
FG0010 subjects
FG00287 subjects
COMPLETED
FG000444 subjects
FG0010 subjects
FG00283 subjects
NOT COMPLETED
FG00052 subjects
FG0010 subjects
FG0024 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0010 subjects
FG0021 subjects
Lack of Efficacy
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
BG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
BG002
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000332
BG001166
BG002168
BG003666
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00045.9± 13.71
BG00147.9± 13.98
BG00244.7± 12.06
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000102
BG00153
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00050
BG00126
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG000267
BG001128
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
All randomized participants in BMS-986165 and Placebo arms
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
Units
Counts
Participants
OG000332
OG001166
Title
Denominators
Categories
Title
Measurements
OG000178
OG00112
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
18.71
2-Sided
95
9.51
36.81
Superiority
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).
All randomized participants in BMS-986165 and Placebo arms
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
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).
All randomized participants
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
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).
Pre-specified for data to be collected only in all randomized from BMS-986165 and Placebo Arms
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
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.
All randomized participants
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
OG002
Apremilast
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).
Pre-specified for data to be collected only in all responders from BMS-986165 and Apremilast Arms
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
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.
All Responders with a baseline PSSD symptom score >= 1
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
OG002
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.
Pre-specified for data to be collected only in all responders with a baseline DLQI score >=2 from BMS-986165 and Placebo Arms
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
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.
Pre-specified for data to be collected only in all responders with a baseline PGA-F score >=3 from BMS-986165 and Placebo Arms
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
Units
Counts
Participants
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).
All randomized participants in BMS-986165 and Apremilast arms
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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.
All randomized participants in BMS-986165 and Apremilast arms
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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.
All responders with a baseline ss-PGA score >=3
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Placebo
Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
OG002
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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.
Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast
Posted
Count of Participants
Participants
Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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).
Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast
Posted
Count of Participants
Participants
Baseline and Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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).
Pre-specified for data to be collected in all randomized who received BMS-986165 only and Apremilast
Posted
Count of Participants
Participants
Baseline and Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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.
Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm
Posted
Count of Participants
Participants
Week 52 and Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
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).
Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm
Posted
Count of Participants
Participants
Baseline, Week 52 and Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
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).
Pre-specified for data to be collected in all responders treated in BMS-986165 arm and Apremilast arm
Posted
Count of Participants
Participants
Baseline, Week 52 and Week 24
ID
Title
Description
OG000
BMS-986165
BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
OG001
Apremilast
Time Frame
Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 24 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 12 months)
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other Adverse Events represents all participants that received at least 1 dose of study medication
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
BMS-986165 Week 0 up to Week 16
BMS-986165 6 mg daily (QD) week 0 - week 16
0
332
7
332
76
332
EG001
Placebo Week 0 up to Week 16
Participants received placebo week 0 - week 16
1
166
9
165
24
165
EG002
Apremilast Week 0 up to Week 16
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 16
0
168
4
168
60
168
EG003
BMS-986165 Week 0 up to Week 52
BMS-986165 6 mg daily (QD) week 0 - week 52
0
531
31
531
197
531
EG004
Placebo Week 0 up to Week 52
Participants received placebo week 0 - week 52
1
166
9
165
24
165
EG005
Apremilast Week 0 up to Week 52
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 52
0
168
6
168
80
168
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia vitamin B12 deficiency
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG0031 affected531 at risk
EG004
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0021 affected168 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0021 affected168 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Intra-abdominal fluid collection
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Hernia perforation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Incarcerated hernia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0021 affected168 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0021 affected168 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0011 affected165 at risk
EG0020 affected168 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected332 at risk
EG0010 affected165 at risk
EG0020 affected168 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00013 affected332 at risk
EG0016 affected165 at risk
EG00217 affected168 at risk
EG00330 affected531 at risk
EG0046 affected165 at risk
EG00519 affected168 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 affected332 at risk
EG0014 affected165 at risk
EG00219 affected168 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00021 affected332 at risk
EG0017 affected165 at risk
EG00214 affected168 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00021 affected332 at risk
EG0016 affected165 at risk
EG0023 affected168 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00016 affected332 at risk
EG0015 affected165 at risk
EG00217 affected168 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0006 affected332 at risk
EG0010 affected165 at risk
EG0026 affected168 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Units
Counts
Participants
OG000332
OG001166
OG002168
Title
Denominators
Categories
Title
Measurements
OG000118
OG0017
OG00233
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
16.15
2-Sided
95
6.91
37.72
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0002
Odds Ratio (OR)
2.40
2-Sided
95
1.51
3.60
Superiority
Units
Counts
Participants
OG000332
OG001166
Title
Denominators
Categories
Title
Measurements
OG00047
OG0011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
31.30
2-Sided
95
4.09
239.36
Superiority
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Units
Counts
Participants
OG000332
OG001166
OG002168
Title
Denominators
Categories
Title
Measurements
OG00058
OG0011
OG0028
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
4.52
2-Sided
95
2.07
9.84
Superiority
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
39.54
2-Sided
95
5.29
295.75
Superiority
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Units
Counts
Participants
OG000306
OG001158
Title
Denominators
Categories
Title
Measurements
OG000-29.4± 24.43
OG001-22.8± 23.40
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.0001
Adjusted Mean Difference
-8.8
Standard Error of the Mean
2.00
2-Sided
95
-12.8
-4.9
Superiority
Apremilast
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Units
Counts
Participants
OG000305
OG001149
OG002158
Title
Denominators
Categories
Title
Measurements
OG00024
OG0011
OG0027
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0013
Odds Ratio (OR)
13.67
2-Sided
95
1.77
105.50
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.1702
Odds Ratio (OR)
1.84
2-Sided
95
0.76
4.42
Superiority
Units
Counts
Participants
OG000322
OG001160
Title
Denominators
Categories
Title
Measurements
OG000132
OG00117
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
6.04
2-Sided
95
3.46
10.53
Superiority
OG00043
OG00134
Title
Denominators
Categories
Title
Measurements
OG0009
OG0013
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1049
Odds Ratio (OR)
2.84
2-Sided
95
0.73
10.96
Superiority
Units
Counts
Participants
OG000332
OG001168
Title
Denominators
Categories
Title
Measurements
OG000194
OG00159
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
2.64
2-Sided
95
1.78
3.91
Superiority
Units
Counts
Participants
OG000332
OG001168
Title
Denominators
Categories
Title
Measurements
OG000178
OG00154
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
2.53
2-Sided
95
1.70
3.78
Superiority
Units
Counts
Participants
OG000209
OG001121
OG002110
Title
Denominators
Categories
Title
Measurements
OG000147
OG00121
OG00243
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
11.92
2-Sided
95
6.69
21.25
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
3.65
2-Sided
95
2.21
6.04
Superiority
Units
Counts
Participants
OG000332
OG001168
Title
Denominators
Categories
Title
Measurements
OG000195
OG00152
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
3.23
2-Sided
95
2.16
4.83
Superiority
Units
Counts
Participants
OG000332
OG001168
Title
Denominators
Categories
Title
Measurements
OG000230
OG00164
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
3.76
2-Sided
95
2.53
5.60
Superiority
Units
Counts
Participants
OG000332
OG001168
Title
Denominators
Categories
Title
Measurements
OG000140
OG00137
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
2.63
2-Sided
95
1.71
4.05
Superiority
Units
Counts
Participants
OG000332
OG001167
Title
Denominators
Categories
Title
Measurements
OG000151
OG00137
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
3.03
2-Sided
95
1.96
4.69
Superiority
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
Units
Counts
Participants
OG000332
OG001167
Title
Denominators
Categories
Title
Measurements
OG000187
OG00151
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
3.11
2-Sided
95
2.06
4.69
Superiority
Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52