An Investigational Study to Evaluate Experimental Medicat... | NCT03611751 | Trialant
NCT03611751
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Dec 20, 2022Actual
Enrollment
1,020Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
BMS-986165
Placebo
Apremilast
Countries
United States
Australia
Canada
Czechia
Finland
France
Germany
Hungary
Israel
Italy
New Zealand
Poland
Puerto Rico
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03611751
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-047
Secondary IDs
ID
Type
Description
Link
2018-001925-24
EudraCT Number
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Acronym
POETYK-PSO-2
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Oct 2022
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
Jul 26, 2018Actual
Primary Completion Date
Nov 29, 2020Actual
Completion Date
Nov 30, 2020Actual
First Submitted Date
Jul 25, 2018
First Submission Date that Met QC Criteria
Aug 1, 2018
First Posted Date
Aug 2, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 6, 2022
Results First Submitted that Met QC Criteria
Nov 26, 2022
Results First Posted Date
Dec 20, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 29, 2021
Certification/Extension First Submitted that Passed QC Review
Nov 26, 2022
Certification/Extension First Posted Date
Dec 20, 2022Actual
Last Update Submitted Date
Nov 26, 2022
Last Update Posted Date
Dec 20, 2022Actual
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
1,020Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BMS-986165
Experimental
BMS-986165 oral administration
Drug: BMS-986165
Placebo
Placebo Comparator
Placebo oral administration
Other: Placebo
Active comparator
Active Comparator
Active comparator oral administration
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 average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Baseline and Week 16
Secondary Outcomes
Measure
Description
Time Frame
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
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 could apply
1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Baseline and Week 16
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).
A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
Baseline and Week 16
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
Week 16
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 .
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.
Week 16
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Baseline and Week 16
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.
From Week 24 to Week 52 (up to approximately 28 weeks)
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Week 24
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Baseline and Week 24
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
Baseline and week 24
Birmingham
Alabama
35233
United States
Alliance Dermatology and Mohs Center - Phoenix
Phoenix
Arizona
85032
United States
Clinical Research Consortium - Tempe
Tempe
Arizona
85283
United States
Johnson Dermatology
Fort Smith
Arkansas
72916
United States
Burke Pharmaceutical Research
Hot Springs
Arkansas
71913
United States
Applied Research Center of Arkansas
Little Rock
Arkansas
72212
United States
Anaheim Clinical Trials
Anaheim
California
92801
United States
Center for Dermatology Clinical Research
Fremont
California
94538
United States
Associates in Research, Inc.
Fresno
California
93720
United States
Marvel Clinical Research
Huntington Beach
California
92647
United States
Interspond - Long Beach Clinical Trials
Long Beach
California
90806
United States
Dermatology Research Associates - Los Angeles
Los Angeles
California
90045-3606
United States
LA Universal Research Center
Los Angeles
California
90057
United States
Artemis Institute for Clinical Research - San Diego
San Diego
California
92103
United States
University of California San Diego Health Systems
San Diego
California
92122
United States
Therapeutics Clinical Research
San Diego
California
92123
United States
San Luis Dermatology and Laser Clinic
San Luis Obispo
California
93405
United States
Artemis Institute for Clinical Research - San Marcos
San Marcos
California
92078
United States
West Coast Research
San Ramon
California
94582
United States
Clinical Science Institute
Santa Monica
California
90404
United States
Synexus - Santa Rosa
Santa Rosa
California
95405
United States
Care Access Research - Walnut Creek
Walnut Creek
California
94598
United States
Stamford Therapeutics Consortium
Stamford
Connecticut
06905
United States
Skin Care Research
Boca Raton
Florida
33486
United States
ERN - Accel Research - Avail
DeLand
Florida
32720
United States
Interspond - Savin Medical Group
Miami Lakes
Florida
33014
United States
Synexus Clinical Research - Saint Petersburg
Pinellas Park
Florida
33781
United States
Progressive Medical Research
Port Orange
Florida
32127
United States
Precision Clinical Research - Corporate Office
Sunrise
Florida
33351
United States
Precision Clinical Research - Corporate Office
Tamarac
Florida
33351
United States
Moore Clinical Research - South Tampa
Tampa
Florida
33609
United States
University of South Florida/USF Health
Tampa
Florida
33612
United States
ForCare Clinical Research
Tampa
Florida
33613
United States
Marietta Dermatology & The Skin Cancer Center
Marietta
Georgia
30060
United States
Advanced Clinical Research - Idaho
Meridian
Idaho
83642
United States
Glazer Dermatology
Buffalo Grove
Illinois
60089
United States
Southern Illinois University School of Medicine
Springfield
Illinois
62702
United States
Dundee Dermatology
West Dundee
Illinois
60118
United States
Dermatology Center of Northwest Indiana
Crown Point
Indiana
46307
United States
Synexus - Evansville South
Evansville
Indiana
47714
United States
Dawes Fretzin Dermatology Group
Indianapolis
Indiana
46250
United States
Skin Sciences
Louisville
Kentucky
40217
United States
Advanced Medical Research
Lacombe
Louisiana
70445
United States
Shondra L. Smith, M.D.
Lake Charles
Louisiana
70605-1213
United States
DelRicht Research - New Orleans - Prytania Street
New Orleans
Louisiana
70115
United States
Ora
Andover
Massachusetts
01810
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02115
United States
Brigham Dermatology Associates
Boston
Massachusetts
02115
United States
A. Alfred Taubman Health Care Center
Ann Arbor
Michigan
48109
United States
Hamzavi Dermatology
Fort Gratiot
Michigan
48059
United States
Washington University School of Medicine - West County Dermatology
Creve Coeur
Missouri
63141
United States
Healthcare Research Network - Hazelwood
Hazelwood
Missouri
63042
United States
Clinical Research Consortium - Las Vegas
Las Vegas
Nevada
89119
United States
ActivMed Practices and Research - Portsmouth
Portsmouth
New Hampshire
03801
United States
Windsor Dermatology
East Windsor
New Jersey
08520
United States
Sadick Research Group
New York
New York
10075
United States
DermResearch Center of New York
Stony Brook
New York
11790
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
PMG Research of Cary
Cary
North Carolina
27615
United States
Dermatology Consulting Services
High Point
North Carolina
27262
United States
Wilmington Dermatology Center
Wilmington
North Carolina
28405
United States
Synexus - Cincinnati
Cincinnati
Ohio
45249
United States
University Hospitals Case Medical Center
Cleveland
Ohio
44106
United States
ClinOhio Research Services
Columbus
Ohio
43213
United States
Wright State Research Institute
Fairborn
Ohio
45324
United States
Central Sooner Research
Norman
Oklahoma
73071
United States
Unity Clinical Research
Oklahoma City
Oklahoma
73118
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
Dermatology and Skin Surgery Center - Exton
Exton
Pennsylvania
19341
United States
Paddington Testing Company
Philadelphia
Pennsylvania
19103
United States
Synexus
Greer
South Carolina
29651
United States
Coastal Carolina Research Center - Mount Pleasant
Mt. Pleasant
South Carolina
29464
United States
Health Concepts
Rapid City
South Dakota
57702
United States
Rivergate Dermatology - Main Office
Goodlettsville
Tennessee
37072
United States
Clinical Research Solutions - Jackson
Jackson
Tennessee
38305
United States
Dermatology Associates of Knoxville
Knoxville
Tennessee
37917
United States
The Skin Wellness Center
Knoxville
Tennessee
37922
United States
Arlington Center for Dermatology
Arlington
Texas
76011
United States
DermResearch
Austin
Texas
78759
United States
Bellaire Dermatology
Bellaire
Texas
77401
United States
Modern Research Associates
Dallas
Texas
75231
United States
Synexus - Dallas
Dallas
Texas
75234
United States
Progressive Clinical Research - San Antonio
San Antonio
Texas
78213-2250
United States
Dermatology Clinical Research Center of San Antonio
San Antonio
Texas
78229
United States
Interspond - Houston Center for Clinical Research
Sugar Land
Texas
77479
United States
West Virginia University
Morgantown
West Virginia
26501
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Woden Dermatology
Phillip
Australian Capital Territory
2606
Australia
Holdsworth House Medical Practice
Darlinghurst
New South Wales
2010
Australia
St. George Dermatology & Skin Care Centre
Kogarah
New South Wales
2217
Australia
Westmead Hospital
Westmead
New South Wales
2145
Australia
The Skin Centre
Benowa
Queensland
4217
Australia
Veracity Clinical Research
Woolloongabba
Queensland
4102
Australia
North Eastern Health Specialists
Hectorville
South Australia
5073
Australia
Box Hill Hospital
Box Hill
Victoria
3128
Australia
Skin and Cancer Foundation
Carlton
Victoria
3053
Australia
Sinclair Dermatology
East Melbourne
Victoria
3002
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Fremantle Dermatology
Fremantle
Western Australia
6160
Australia
Institute for Skin Advancement
Calgary
Alberta
T3E 0B2
Canada
Stratica Medical
Edmonton
Alberta
T5K 1X3
Canada
University of British Columbia
Vancouver
British Columbia
V5Z 4E8
Canada
CCA Medical Research
Ajax
Ontario
L1S 7K8
Canada
Mediprobe Research
London
Ontario
N5X 2P1
Canada
DermEffects
London
Ontario
N6H 5L5
Canada
Lynderm Research
Markham
Ontario
L3P 1X2
Canada
DermEdge
Mississauga
Ontario
L5H 1G9
Canada
York Dermatology Clinic and Research Centre
Mississauga
Ontario
L5H 1G9
Canada
Office of Dr. Niakosari Firouzeh
North York
Ontario
M2M 4J5
Canada
Dermatology Ottawa Research Centre
Ottawa
Ontario
K2C 3N2
Canada
Toronto Dermatology Centre
Toronto
Ontario
M3H 5Y8
Canada
Dermatology on Bloor
Toronto
Ontario
M4W 2N4
Canada
Kim Papp Clinical Research
Waterloo
Ontario
N2J 1C4
Canada
Dr. Isabelle Delorme
Drummondville
Quebec
J2B 5L5
Canada
Innovaderm Research
Montreal
Quebec
H2X 2V1
Canada
Nemocnice Jihlava
Jihlava
586 01
Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín
741 01
Czechia
MUDr. Helena Korandova
Olomouc
779 00
Czechia
Fakultni Nemocnice Ostrava
Ostrava
708 52
Czechia
Clintrial
Prague
100 00
Czechia
Sanatorium profesora Arenbergera
Prague
110 00
Czechia
Kozni a zilni ambulance
Ústí nad Labem
400 10
Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem
401 13
Czechia
Terveystalo Tampere
Tampere
33100
Finland
Mehilainen Turku
Turku
20100
Finland
Local Institution - 0197
Vaasa
65130
Finland
Hopital Prive dAntony
Antony
92160
France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest
29609
France
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice
06202
France
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
Toulouse
31059
France
Local Institution - 0128
Augsburg
86179
Germany
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum
44793
Germany
Hautarztpraxis Dr. Beatrice Gerlach
Dresden
01097
Germany
Local Institution - 0246
Frankfurt am Main
60313
Germany
Local Institution - 0119
Hamburg
20253
Germany
Medizinische Hochschule Hannover
Hanover
30625
Germany
Dermakiel - Allergie Und Haut Centrum
Kiel
24148
Germany
Praxis Dr. Beate Schwarz
Langenau
89129
Germany
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
Lübeck
23538
Germany
Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
München
80802
Germany
Harzklinikum Dorothea Christiane Erxleben
Quedlinburg
06484
Germany
Praxis Dr. med. Wilfried Steinborn
Straubing
94315
Germany
CentroDerm GmbH
Wuppertal
42287
Germany
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest
1036
Hungary
Synexus Magyarorszag
Budapest
1036
Hungary
Semmelweis Egyetem
Budapest
1085
Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
Debrecen
4025
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
Gyula
5700
Hungary
Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
Bologna
40138
Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
Pisa
56126
Italy
Local Institution
Hamilton
3206
New Zealand
Local Institution
Mount Cook
6021
New Zealand
Local Institution
Tauranga
3110
New Zealand
ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok
15-351
Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok
15-879
Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag
82-300
Poland
Synexus Polska Oddzial w Gdansk
Gda?sk
80-382
Poland
Zespol Naukowo-Leczniczy Iwolang
Iwonicz-Zdrój
38-440
Poland
Krakowskie Centrum Medyczne
Krakow
31-501
Poland
Dermed Centrum Medyczne
Lodz
90-265
Poland
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
Lodz
90-436
Poland
Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
Lublin
20-406
Poland
ETG - Siedlce
Siedlce
08-110
Poland
ETG - Skierniewice
Skierniewice
96-100
Poland
Local Institution - 0142
Torun
87-100
Poland
High-Med Przychodnia Specjalistyczna
Warsaw
01-817
Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw
02-008
Poland
ETG - Warszawa
Warsaw
02-793
Poland
Klinika Ambroziak
Warsaw
02-953
Poland
Local Institution - 0183
Wroclaw
52-416
Poland
GCM Medical Group
San Juan
917
Puerto Rico
Local Institution - 0156
Córdoba
14004
Spain
Hospital Universitario de Vinalopo
Elche
03293
Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria
35010
Spain
Hospital Universitario Ramon Y Cajal
Madrid
28034
Spain
Hospital de Manises
Manises
46940
Spain
Hospital Universitario Virgen de la Victoria
Mߧa
29010
Spain
Local Institution - 0137
Pozuelo de Alarcón
28223
Spain
Burbage Surgery
Santiago de Compostela
15706
Spain
Consorci Hospital General Universitari de Valencia
Valencia
46014
Spain
Ladulaas Kliniska Studier
Borås
506 30
Sweden
Pharmasite - Helsingborg
Helsingborg
25200
Sweden
ProbarE i Lund
Lund
22222
Sweden
PharmaSite - Malmo
Malmö
211 52
Sweden
Karolinska Universitetssjukhuset
Solna
171 76
Sweden
MAC Clinical Research - Cannock
Cannock
WS11 0BN
United Kingdom
Ashgate Medical Practice
Chesterfield
S40 4AA
United Kingdom
Local Institution - 0189
Chorley
PR7 7NA
United Kingdom
Mounts Bay Medical
Cornwall
TR27 5DT
United Kingdom
The Dudley Group NHS Foundation Trust
Dudley
DY1 2HQ
United Kingdom
MAC Clinical Research - Stockton
Durham
TS17 6EW
United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds
LS7 4SA
United Kingdom
MAC Clinical Research - Manchester
Manchester
M13 9NQ
United Kingdom
Merola JF, Mease PJ, Armstrong AW, Strand V, Lehman T, Varga S, Choi JC, Becker B, Zhong Y, Colombo MJ, Thaci D, Bili A, Gottlieb AB. Deucravacitinib in Patients with Plaque Psoriasis Who Screened Positive for Psoriatic Arthritis: Improvements in Joint Pain and the Impact of Musculoskeletal Symptoms. Dermatol Ther (Heidelb). 2025 Aug;15(8):2281-2293. doi: 10.1007/s13555-025-01428-9. Epub 2025 May 30.
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.
Strober B, Thaci D, Sofen H, Kircik L, Gordon KB, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp KA. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy. 2023 Aug;15(11):787-797. doi: 10.2217/imt-2023-0062. Epub 2023 May 7.
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
FG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
FG000511 subjects
FG001255 subjects
FG002254 subjects
COMPLETED
FG000510 subjects
FG001254 subjects
FG002254 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Randomized but not treated
FG0001 subjects
FG0011 subjects
FG0020 subjects
Treatment Week 0 - Week 16
Type
Comment
Milestone Data
STARTED
FG000510 subjects
FG001254 subjects
FG002254 subjects
COMPLETED
FG000456 subjects
FG001212 subjects
FG002217 subjects
NOT COMPLETED
FG00054 subjects
FG00142 subjects
FG00237 subjects
Type
Comment
Reasons
Adverse Event
FG00011 subjects
FG0017 subjects
FG00212 subjects
Lack of Efficacy
FG000
Treatment Week 16 - Week 24
Type
Comment
Milestone Data
STARTED
FG000667 subjects
FG0010 subjects
FG002217 subjects
COMPLETED
FG000642 subjects
FG0010 subjects
FG002208 subjects
NOT COMPLETED
FG00025 subjects
FG0010 subjects
FG0029 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0010 subjects
FG0022 subjects
Lack of Efficacy
FG000
Treatment Week 24 - Week 52
Type
Comment
Milestone Data
STARTED
FG000604 subjects
FG001247 subjects
FG0020 subjects
COMPLETED
FG000535 subjects
FG001214 subjects
FG0020 subjects
NOT COMPLETED
FG00069 subjects
FG00133 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG00014 subjects
FG0017 subjects
FG0020 subjects
Lack of Efficacy
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
BG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
BG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000511
BG001255
BG002254
BG0031020
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
BG00046.9± 13.37
BG00147.3± 13.57
BG00246.4± 13.28
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000175
BG00174
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00058
BG00129
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG000474
BG001232
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 average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants in the BMS-986165 and Placebo arms
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Units
Counts
Participants
OG000511
OG001255
Title
Denominators
Categories
Title
Measurements
OG000253
OG00122
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)
10.55
2-Sided
95
6.54
17.00
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)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants in the BMS-986165 and Placebo arms
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
Secondary
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Secondary
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Secondary
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants
Posted
Count of Participants
Participants
No
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Secondary
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).
A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
All randomized participants with evaluable baseline and week 16 PSSD scores.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Secondary
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
All randomized participants with a baseline PSSD symptom score ≥ 1
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Secondary
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 .
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants with a baseline ss-PGA score >=3
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Secondary
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants with a baseline DLQI score >=2. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.
Posted
Count of Participants
Participants
No
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Secondary
The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants with a baseline PGA-F score >=3. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.
Posted
Count of Participants
Participants
No
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Secondary
The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.
All randomized participants with a baseline pp-PGA score >=3.
Posted
Count of Participants
Participants
No
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at 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 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants in the BMS-986165 and Apremilast arms.
Posted
Count of Participants
Participants
Baseline and Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
Secondary
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
All randomized participants in the BMS-986165 and Apremilast arms.
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Secondary
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.
All randomized participants who had PASI 75 response at week 24. Pre-specified to report participants from their original randomization.
Posted
Median
95% Confidence Interval
Days
From Week 24 to Week 52 (up to approximately 28 weeks)
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
OG002
Apremilast
Secondary
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.
Posted
Count of Participants
Participants
No
Week 24
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
OG001
Apremilast
Secondary
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.
Posted
Count of Participants
Participants
No
Baseline and Week 24
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
Secondary
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).
Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.
Posted
Count of Participants
Participants
No
Baseline and week 24
ID
Title
Description
OG000
BMS-986165
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).
Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
Time Frame
Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks)
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) 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)
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)
1
511
8
510
114
510
EG001
Placebo (Week 0 up to Week 16)
Participants receive Placebo by oral administration once daily (QD)
0
255
3
254
61
254
EG002
Apremilast (Week 0 up to Week 16)
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards
1
254
1
254
86
254
EG003
BMS-986165 (Week 0 up to Week 52)
Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)
2
834
24
833
249
833
EG004
Placebo (Week 0 up to Week 52)
Participants receive Placebo by oral administration once daily (QD)
0
502
5
501
97
501
EG005
Apremilast (Week 0 up to Week 52)
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards
1
254
3
254
98
254
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG0031 affected833 at risk
EG0040 affected501 at risk
EG0050 affected254 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Gastrointestinal arteriovenous malformation
Congenital, familial and genetic disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0021 affected254 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Anal polyp
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0021 affected254 at risk
EG003
Pancreatic mass
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0011 affected254 at risk
EG0020 affected254 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Purulence
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Vascular graft infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0021 affected254 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0021 affected254 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0011 affected254 at risk
EG0020 affected254 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0011 affected254 at risk
EG0020 affected254 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0011 affected254 at risk
EG0020 affected254 at risk
EG003
Shock
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected510 at risk
EG0010 affected254 at risk
EG0020 affected254 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00024 affected510 at risk
EG00119 affected254 at risk
EG00233 affected254 at risk
EG00339 affected833 at risk
EG00422 affected501 at risk
EG00535 affected254 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0007 affected510 at risk
EG0013 affected254 at risk
EG00223 affected254 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00055 affected510 at risk
EG00129 affected254 at risk
EG00223 affected254 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00025 affected510 at risk
EG00111 affected254 at risk
EG00214 affected254 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00022 affected510 at risk
EG00114 affected254 at risk
EG00228 affected254 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.
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Units
Counts
Participants
OG000511
OG001255
Title
Denominators
Categories
Title
Measurements
OG000271
OG00124
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)
10.49
2-Sided
95
6.65
16.55
Superiority
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000511
OG001255
OG002254
Title
Denominators
Categories
Title
Measurements
OG000138
OG0017
OG00246
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)
11.42
2-Sided
95
5.45
23.93
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0046
Odds Ratio (OR)
1.74
2-Sided
95
1.18
2.56
Superiority
Placebo
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000511
OG001255
OG002254
Title
Denominators
Categories
Title
Measurements
OG00052
OG0013
OG00211
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
<0.001
Odds Ratio (OR)
9.21
2-Sided
95
2.89
29.40
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0051
Odds Ratio (OR)
2.55
2-Sided
95
1.30
5.00
Superiority
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000511
OG001255
OG002254
Title
Denominators
Categories
Title
Measurements
OG00080
OG0013
OG00216
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)
14.44
2-Sided
95
4.62
45.11
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0002
Odds Ratio (OR)
2.85
2-Sided
95
1.61
5.03
Superiority
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000466
OG001239
OG002233
Title
Denominators
Categories
Title
Measurements
OG000-28.9± 25.22
OG001-4.2± 19.58
OG002-21.5± 25.44
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
Mean Difference (Net)
-23.6
Standard Error of the Mean
1.67
2-Sided
95
-26.9
-20.3
Superiority
OG000
OG002
ANCOVA
<0.0001
Mean Difference (Net)
-7.2
Standard Error of the Mean
1.68
2-Sided
95
-10.5
-3.9
Superiority
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000466
OG001238
OG002232
Title
Denominators
Categories
Title
Measurements
OG00035
OG0013
OG00210
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
0.0005
Odds Ratio (OR)
6.40
2-Sided
95
1.94
21.15
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0928
Odds Ratio (OR)
1.82
2-Sided
95
0.89
3.71
Superiority
OG002
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000305
OG001173
OG002166
Title
Denominators
Categories
Title
Measurements
OG000182
OG00130
OG00261
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)
6.85
2-Sided
95
4.34
10.81
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
<0.0001
Odds Ratio (OR)
2.63
2-Sided
95
1.77
3.91
Superiority
Participants receive Placebo by oral administration once daily (QD).
Participants originally randomized to placebo switch to BMS-986165 at Week 16.
Units
Counts
Participants
OG000495
OG001246
Title
Denominators
Categories
Title
Measurements
OG000186
OG00124
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)
5.38
2-Sided
95
3.42
8.47
Superiority
Units
Counts
Participants
OG00069
OG00138
Title
Denominators
Categories
Title
Measurements
OG00014
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
0.0621
Odds Ratio (OR)
3.21
2-Sided
95
0.88
11.79
Superiority
Units
Counts
Participants
OG00039
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG00018
OG0014
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
OG001
Cochran-Mantel-Haenszel
0.6692
Odds Ratio (OR)
0.64
2-Sided
95
0.06
7.46
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.3793
Odds Ratio (OR)
0.32
2-Sided
95
0.02
5.56
Superiority
OG001
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000511
OG001254
Title
Denominators
Categories
Title
Measurements
OG000271
OG001101
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
0.0004
Odds Ratio (OR)
1.76
2-Sided
95
1.29
2.41
Superiority
Units
Counts
Participants
OG000511
OG001254
Title
Denominators
Categories
Title
Measurements
OG000253
OG00186
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)
2.01
2-Sided
95
1.45
2.78
Superiority
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000145
OG001150
OG00295
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Insufficient number of participants with events
OG001NA(NA to NA)Insufficient number of participants with events
OG002197.0(125.0 to NA)Insufficient number of participants with events
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
Log Rank
<0.0001
Superiority
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000504
OG001254
Title
Denominators
Categories
Title
Measurements
OG000251
OG00175
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)
2.47
2-Sided
95
1.78
3.43
Superiority
OG001
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Units
Counts
Participants
OG000504
OG001254
Title
Denominators
Categories
Title
Measurements
OG000296
OG00196
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)
2.44
2-Sided
95
1.78
3.36
Superiority
OG001
Apremilast
Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)
10 mg used for titration Day 1 through Day 3 morning dose
20 mg used for titration Day 3 evening dose through Day 5 morning dose.
30 mg from Day 5 evening dose onwards.
Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.