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 (POETYK-PSO-2)

November 26, 2022 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1020

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Kogarah, New South Wales, Australia, 2217
        • St. George Dermatology & Skin Care Centre
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research
    • South Australia
      • Hectorville, South Australia, Australia, 5073
        • North Eastern Health Specialists
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Carlton, Victoria, Australia, 3053
        • Skin and Cancer Foundation
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Institute For Skin Advancement
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • University of British Columbia
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • CCA Medical Research
      • London, Ontario, Canada, N6H 5L5
        • DermEffects
      • London, Ontario, Canada, N5X 2P1
        • Mediprobe Research
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge
      • Mississauga, Ontario, Canada, L5H 1G9
        • York Dermatology Clinic and Research Centre
      • North York, Ontario, Canada, M2M 4J5
        • Office of Dr. Niakosari Firouzeh
      • Ottawa, Ontario, Canada, K2C 3N2
        • Dermatology Ottawa Research Centre
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Dermatology Centre
      • Toronto, Ontario, Canada, M4W 2N4
        • Dermatology on Bloor
      • Waterloo, Ontario, Canada, N2J 1C4
        • Kim Papp Clinical Research
    • Quebec
      • Drummondville, Quebec, Canada, J2B 5L5
        • Dr. Isabelle Delorme
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research
  • Czechia
      • Jihlava 1, Czechia, 586 01
        • Nemocnice Jihlava
      • Novy Jicin, Czechia, 741 01
        • Nemocnice Novy Jicin a.s.
      • Olomouc, Czechia, 779 00
        • MUDr. Helena Korandova
      • Ostrava, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Praha 1, Czechia, 110 00
        • Sanatorium Profesora Arenbergera
      • Praha 10, Czechia, 100 00
        • Clintrial
      • Usti nad Labem, Czechia, 400 10
        • Kozni a zilni ambulance
      • Usti nad Labem, Czechia, 401 13
        • Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
  • Finland
      • Tampere, Finland, 33100
        • Terveystalo Tampere
      • Turku, Finland, 20100
        • Mehiläinen Turku
      • Vaasa, Finland, 65130
        • Local Institution - 0197
  • France
      • Antony, France, 92160
        • Hopital Prive dAntony
      • Brest Cedex, France, 29609
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Nice Cedex 3, France, 06202
        • Centre Hospitalier Universitaire de Nice Hopital lArchet
      • Toulouse Cedex 9, France, 31059
        • Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
  • Germany
      • Augsburg, Germany, 86179
        • Local Institution - 0128
      • Bochum, Germany, 44793
        • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
      • Dresden, Germany, 01097
        • Hautarztpraxis Dr. Beatrice Gerlach
      • Frankfurt am Main, Germany, 60313
        • Local Institution - 0246
      • Hamburg, Germany, 20253
        • Local Institution - 0119
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Kiel, Germany, 24148
        • DermaKiel - Allergie und Haut Centrum
      • Langenau, Germany, 89129
        • Praxis Dr. Beate Schwarz
      • Lubeck, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein - Campus Lubeck
      • Munchen, Germany, 80802
        • Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
      • Quedlinburg, Germany, 06484
        • Harzklinikum Dorothea Christiane Erxleben
      • Straubing, Germany, 94315
        • Praxis Dr. med. Wilfried Steinborn
      • Wuppertal, Germany, 42287
        • CentroDerm GmbH
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag
      • Budapest, Hungary, 1036
        • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungary, 4025
        • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
      • Gyula, Hungary, 5700
        • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
      • Pecs, Hungary, 7632
        • Pecsi Tudomanyegyetem Klinikai Kozpont
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem
      • Szolnok, Hungary, 5000
        • Allergo-Derm Bakos
      • Zalaegerszeg, Hungary, 8900
        • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
  • Israel
      • Haifa, Israel, 3436212
        • Local Institution
      • Kfar Saba, Israel, 4428164
        • Local Institution
      • Petah Tikva, Israel, 49100
        • Local Institution
      • Ramat Gan, Israel, 52621
        • Local Institution
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
  • New Zealand
      • Hamilton, New Zealand, 3206
        • Local Institution
      • Mount Cook, New Zealand, 6021
        • Local Institution
      • Tauranga, New Zealand, 3110
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-351
        • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
      • Bialystok, Poland, 15-879
        • ClinicMed Daniluk Nowak Spolka Jawna
      • Elblag, Poland, 82-300
        • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
      • Gda?sk, Poland, 80-382
        • Synexus Polska Oddzial w Gdansk
      • Iwonicz-Zdroj, Poland, 38-440
        • Zespol Naukowo-Leczniczy Iwolang
      • Krakow, Poland, 31-501
        • Krakowskie Centrum Medyczne
      • Lodz, Poland, 90-265
        • Dermed Centrum Medyczne
      • Lodz, Poland, 90-436
        • Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
      • Lublin, Poland, 20-406
        • Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
      • Siedlce, Poland, 08-110
        • ETG - Siedlce
      • Skierniewice, Poland, 96-100
        • ETG - Skierniewice
      • Torun, Poland, 87-100
        • Local Institution - 0142
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak
      • Warszawa, Poland, 01-817
        • High-Med Przychodnia Specjalistyczna
      • Warszawa, Poland, 02-008
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
      • Warszawa, Poland, 02-793
        • ETG - Warszawa
      • Wroclaw, Poland, 52-416
        • Local Institution - 0183
  • Puerto Rico
      • San Juan, Puerto Rico, 917
        • GCM Medical Group
  • Spain
      • Cordoba, Spain, 14004
        • Local Institution - 0156
      • Elche, Spain, 03293
        • Hospital Universitario de Vinalopó
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Manises, Spain, 46940
        • Hospital de Manises
      • Mߧa, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Pozuelo de Alarcon, Spain, 28223
        • Local Institution - 0137
      • Santiago de Compostela, Spain, 15706
        • Burbage Surgery
      • Valencia, Spain, 46014
        • Consorci Hospital General Universitari de València
  • Sweden
      • Boras, Sweden, 506 30
        • Ladulaas Kliniska Studier
      • Helsingborg, Sweden, 25200
        • Pharmasite - Helsingborg
      • Lund, Sweden, 22222
        • ProbarE i Lund
      • Malmo, Sweden, 211 52
        • PharmaSite - Malmo
      • Solna, Sweden, 171 76
        • Karolinska Universitetssjukhuset
  • United Kingdom
      • Cannock, United Kingdom, WS11 0BN
        • MAC Clinical Research - Cannock
      • Chesterfield, United Kingdom, S40 4AA
        • Ashgate Medical Practice
      • Chorley, United Kingdom, PR7 7NA
        • Local Institution - 0189
      • Cornwall, United Kingdom, TR27 5DT
        • Mounts Bay Medical
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
      • Durham, United Kingdom, TS17 6EW
        • MAC Clinical Research - Stockton
      • Leeds, United Kingdom, LS7 4SA
        • The Leeds Teaching Hospitals Nhs Trust
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research - Manchester
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin And Beauty Dermatology Center
      • Birmingham, Alabama, United States, 35233
        • The Kirklin Clinic of UAB Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and Mohs Center - Phoenix
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium - Tempe
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research
      • Fresno, California, United States, 93720
        • Associates In Research, Inc.
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research
      • Long Beach, California, United States, 90806
        • Interspond - Long Beach Clinical Trials
      • Los Angeles, California, United States, 90057
        • LA Universal Research Center
      • Los Angeles, California, United States, 90045-3606
        • Dermatology Research Associates - Los Angeles
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Diego, California, United States, 92103
        • Artemis Institute For Clinical Research - San Diego
      • San Diego, California, United States, 92122
        • University of California San Diego Health Systems
      • San Luis Obispo, California, United States, 93405
        • San Luis Dermatology and Laser Clinic
      • San Marcos, California, United States, 92078
        • Artemis Institute for Clinical Research - San Marcos
      • San Ramon, California, United States, 94582
        • West Coast Research
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Santa Rosa, California, United States, 95405
        • Synexus - Santa Rosa
      • Walnut Creek, California, United States, 94598
        • Care Access Research - Walnut Creek
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research
      • DeLand, Florida, United States, 32720
        • ERN - Accel Research - Avail
      • Miami Lakes, Florida, United States, 33014
        • Interspond - Savin Medical Group
      • Pinellas Park, Florida, United States, 33781
        • Synexus Clinical Research - Saint Petersburg
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research - Corporate Office
      • Tamarac, Florida, United States, 33351
        • Precision Clinical Research - Corporate Office
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
      • Tampa, Florida, United States, 33609
        • Moore Clinical Research - South Tampa
      • Tampa, Florida, United States, 33612
        • University of South Florida/USF Health
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology & The Skin Cancer Center
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research - Idaho
    • Illinois
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Dermatology Center of Northwest Indiana
      • Evansville, Indiana, United States, 47714
        • Synexus - Evansville South
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Dermatology Group
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences
    • Louisiana
      • Lacombe, Louisiana, United States, 70445
        • Advanced Medical Research
      • Lake Charles, Louisiana, United States, 70605-1213
        • Shondra L. Smith, M.D.
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research - New Orleans - Prytania Street
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham Dermatology Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • A. Alfred Taubman Health Care Center
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Washington University School of Medicine - West County Dermatology
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network - Hazelwood
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Clinical Research Consortium - Las Vegas
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices and Research - Portsmouth
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Windsor Dermatology
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10075
        • Sadick Research Group
      • Stony Brook, New York, United States, 11790
        • DermResearch Center of New York
    • North Carolina
      • Cary, North Carolina, United States, 27615
        • PMG Research of Cary
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
      • Wilmington, North Carolina, United States, 28405
        • Wilmington Dermatology Center
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Synexus - Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43213
        • ClinOhio Research Services
      • Fairborn, Ohio, United States, 45324
        • Wright State Research Institute
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, United States, 73118
        • Unity Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Dermatology and Skin Surgery Center - Exton
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Company
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Synexus
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center - Mount Pleasant
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology - Main Office
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions - Jackson
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center
      • Knoxville, Tennessee, United States, 37917
        • Dermatology Associates of Knoxville
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Center for Dermatology
      • Austin, Texas, United States, 78759
        • DermResearch
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Dallas, Texas, United States, 75234
        • Synexus - Dallas
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, United States, 78213-2250
        • Progressive Clinical Research - San Antonio
      • Sugar Land, Texas, United States, 77479
        • Interspond - Houston Center for Clinical Research
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo oral administration
Other: Placebo
Specified dose on specified days
Experimental: BMS-986165
BMS-986165 oral administration
Drug: BMS-986165
Specified dose on specified days
Active Comparator: Active comparator
Active comparator oral administration
Drug: Apremilast
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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)
Time Frame: Week 16

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)
Time Frame: Baseline and Week 16

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: Baseline and Week 16

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Baseline and Week 16
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
Time Frame: Baseline and Week 16

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)
Time Frame: Week 16

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
Time Frame: Baseline and 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
Time Frame: 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)
Time Frame: Week 16

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)
Time Frame: Week 16

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)
Time Frame: Week 16

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)
Time Frame: Week 16
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)
Time Frame: Baseline and Week 16

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)
Time Frame: Week 16

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
Time Frame: From Week 24 to Week 52 (up to approximately 28 weeks)

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)
Time Frame: Week 24

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)
Time Frame: Baseline and Week 24

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)
Time Frame: Baseline and week 24

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-047
  • 2018-001925-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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