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Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis (POETYK-PSO-1)

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo
Apremilast
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Plaque psoriasis for at least 6 months
  • Moderate to severe disease
  • Candidate for phototherapy or systemic therapy

Exclusion Criteria:

  • Other forms of psoriasis
  • History of recent infection
  • Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Achieve Clinical Research
  • Coastal Clinical Research - Mobile
  • Elite Clinical Studies
  • Arizona Research Center
  • Synexus - Tucson
  • Hull Dermatology
  • First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
  • University California at Irvine Dermatology Clinical Research Center
  • Keck School of Medicine
  • Dream Team Clinical Research
  • University Dermatology Group
  • Unison Clinical Trials
  • New England Research Associates
  • Precision Clinical Research
  • Indago Research and Health Center
  • San Marcus Research Clinic
  • LCC Medical Research
  • International Dermatology Research
  • Well Pharma Medical Research
  • Miami Dade Medical Research Institute
  • Renstar Medical Research
  • Ameriderm Research
  • Olympian Clinical Research
  • Palm Beach Research Center
  • Hamilton Dermatology
  • Healthcare Research Network - Flossmoor
  • Springfield Clinic
  • Deaconess Clinic Downtown
  • The Dermatology Center
  • The Indiana Clinical Trials Center
  • The South Bend Clinic
  • Kansas City Dermatology
  • Dermatology Specialists Research-Kentucky
  • Clinical Trials of America - Monroe
  • Etre Cosmetic Dermatology and Laser Center
  • ActivMed Practices and Research - Beverly
  • DermCare Experts
  • David Fivenson MD Dermatology
  • Somerset Skin Centre
  • Associated Skin Care Specialists - Minnesota Clinical Study Center
  • MediSearch Clinical Trials
  • Dartmouth-Hitchcock Medical Center
  • Hassman Research Institute
  • Forest Hills Dermatology Group
  • Mount Sinai - Queens
  • PMG Research of Charlotte
  • Duke University Health System - Duke Clinic
  • M3 Wake Research, Inc.
  • The Ohio State University Wexner Medical Center
  • Synexus - Columbus
  • Health Research of Oklahoma
  • Oregon Medical Research Center
  • University of Pittsburgh Medical Center
  • Clinical Research Center of Reading
  • Synexus Clinical Research - Anderson
  • Clinical Research Center of the Carolinas
  • Interspond - Stones River Dermatology - Murfreesboro Office
  • Westlake Dermatology - Westlake
  • Dermatology Treatment and Research Center
  • Metroplex Clinical Research Center
  • Menter Dermatology Research Institute
  • Austin Institute for Clinical Research - Pflugerville
  • University of Texas Health Science Center at San Antonio
  • Interspond - Acclaim Dermatology
  • Center for Clinical Studies - Webster
  • Dermatology Associates of Seattle
  • Eastern Washington Dermatology
  • Kirk Barber Research
  • Dr. Chih-ho Hong Medical Inc.
  • Wiseman Dermatology Research
  • The Guenther Dermatology Research Centre
  • Office of Dr. Arnon Moshe Katz
  • North Bay Dermatology Centre
  • Institute of Cosmetic and Laser Surgery
  • Skin Centre for Dermatology
  • The Centre for Dermatology - Richmond Hill
  • XLR8 Medical Research
  • Docteur David Gratton Dermatologue
  • Siena Medical Research
  • Centre de Recherche Dermatologique du Quebec Metropolitain
  • Local Institution
  • Local Institution
  • Local Institution
  • Charite Universitatsmedizin Berlin
  • Klinische Forschung Dresden GmbH
  • Local Institution - 0165
  • Local Institution - 0181
  • Fukuoka University Hospital
  • University of Occupational and Environmental Health, Japan
  • Sapporo Skin Clinic
  • Kobe University Hospital
  • Local Institution - 0182
  • National Hospital Organization Yokohama Medical Center
  • Local Institution - 0169
  • Kochi Medical School Hospital
  • University Hospital - Kyoto Preferctural University of Medicine
  • Mie University Hospital
  • Local Institution - 0166
  • Kurashiki Central Hospital
  • Hamamatsu University Hospital
  • Jichi Medical University Hospital
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • The Jikei University Hospital
  • Local Institution - 0188
  • Local Institution - 0175
  • Local Institution - 0108
  • Kumamoto University Hospital
  • Kyoto University Hospital
  • Local Institution - 0167
  • Local Institution - 0160
  • Local Institution
  • Local Institution - 0187
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0191
  • Local Institution - 0201
  • Local Institution - 0144
  • Synexus - Katowice
  • Local Institution - 0079
  • Centrum Terapii Wspolczesnej
  • Centrum Medyczne All-Med
  • Miejski Szpital Zespolony w Olsztynie
  • DermoDent - Centrum Medyczne Czajkowscy
  • Solumed Centrum Medyczne
  • Local Institution - 0200
  • Clinical Research Group
  • Center for Clinical Studies - Texas Medical Center
  • Lukasz Matusiak 4health
  • dermMedica Sp. z o.o.
  • Local Institution - 0203
  • Local Institution - 0131
  • Azbuka Zdorovya Medical Center
  • Local Institution - 0172
  • Local Institution - 0140
  • Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
  • State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
  • Clinic of Skin Diseases of Pierre Wolkenstein
  • Polyclinic of Private Security Personnel
  • Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
  • Ars Vitae Multidisciplinary Medical Center
  • Klinika Kozhnykh I Venericheskikh Bolezney
  • Smolensk State Medical University
  • MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
  • Local Institution - 0121
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Cruces
  • Hospital del Mar - Parc de Salut Mar
  • Hospital Universitario La Paz
  • Hospital Universitario de Fuenlabrada
  • Local Institution - 0097
  • Local Institution
  • Local Institution
  • Local Institution
  • MAC Clinical Research - Blackpool
  • Synexus - Merseyside Clinical Research Centre
  • Guys and Saint Thomas NHS Foundation Trust
  • Synexus - Manchester Clinical Research Centre
  • Salford Royal NHS Foundation Trust
  • Newcastle upon Tyne Hospitals NHS Foundation Trust
  • MAC Clinical Research - Liverpool

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

BMS-986165

Placebo

Apremilast

Arm Description

Outcomes

Primary Outcome Measures

The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Secondary Outcome Measures

The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16
PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data. Baseline is defined as the measurement at the randomization visit (Week 0).
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16
PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1.
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (0 = "not at all"; 1 = "a little"; 2 = "a lot"; or 3 = "very much"). The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score >=2.
Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16
PGA-F overall condition of the fingernails is rated on a 5-point scale (0 = clear; 1 = minimal; 2 = mild; 3 = moderate; and 4 = severe). PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (0 = absence of disease; 1 = very mild disease; 2 = mild disease; 3 = moderate disease; 4 = severe disease). ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score >=3.
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90)
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Full Information

First Posted
August 7, 2018
Last Updated
January 9, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03624127
Brief Title
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
Acronym
POETYK-PSO-1
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
September 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Apremilast
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Apremilast
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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)
Description
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Time Frame
Week 16
Title
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)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 16
Title
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 16
Title
The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)
Description
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Time Frame
Week 16
Title
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16
Description
PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores, where 0 representing the least severe symptom/sign and 100 the most severe. A mBOCF approach will be used for missing data. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 16
Title
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16
Description
PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1.
Time Frame
Week 16
Title
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)
Description
DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (0 = "not at all"; 1 = "a little"; 2 = "a lot"; or 3 = "very much"). The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score >=2.
Time Frame
Week 16
Title
Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16
Description
PGA-F overall condition of the fingernails is rated on a 5-point scale (0 = clear; 1 = minimal; 2 = mild; 3 = moderate; and 4 = severe). PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.
Time Frame
Week 16
Title
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)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 16
Title
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
Description
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.
Time Frame
Week 16
Title
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)
Description
ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (0 = absence of disease; 1 = very mild disease; 2 = mild disease; 3 = moderate disease; 4 = severe disease). ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score >=3.
Time Frame
Week 16
Title
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1)
Description
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason.
Time Frame
Week 24
Title
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 24
Title
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 24 or who have missing week 24 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline and Week 24
Title
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1)
Description
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.
Time Frame
Week 52 and Week 24
Title
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline, Week 52 and Week 24
Title
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90)
Description
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
Time Frame
Baseline, Week 52 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Plaque psoriasis for at least 6 months Moderate to severe disease Candidate for phototherapy or systemic therapy Exclusion Criteria: Other forms of psoriasis History of recent infection Prior exposure to BMS-986165 or active comparator Other protocol defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Coastal Clinical Research - Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Synexus - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Hull Dermatology
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University California at Irvine Dermatology Clinical Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Dream Team Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
University Dermatology Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Unison Clinical Trials
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
New England Research Associates
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Precision Clinical Research
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
LCC Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Well Pharma Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7118
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409-3401
Country
United States
Facility Name
Hamilton Dermatology
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Healthcare Research Network - Flossmoor
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47708
Country
United States
Facility Name
The Dermatology Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
The South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kansas City Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Dermatology Specialists Research-Kentucky
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Clinical Trials of America - Monroe
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Etre Cosmetic Dermatology and Laser Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States
Facility Name
ActivMed Practices and Research - Beverly
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
DermCare Experts
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
David Fivenson MD Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Associated Skin Care Specialists - Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11374
Country
United States
Facility Name
Mount Sinai - Queens
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Duke University Health System - Duke Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Synexus - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2433
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223-6683
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Research Center of Reading
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Synexus Clinical Research - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Interspond - Stones River Dermatology - Murfreesboro Office
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Westlake Dermatology - Westlake
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Austin Institute for Clinical Research - Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Interspond - Acclaim Dermatology
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Center for Clinical Studies - Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Eastern Washington Dermatology
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Wiseman Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Office of Dr. Arnon Moshe Katz
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 6P5
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Institute of Cosmetic and Laser Surgery
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Skin Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology - Richmond Hill
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
XLR8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Docteur David Gratton Dermatologue
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Siena Medical Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Local Institution - 0165
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution - 0181
City
Toon-Shi
State/Province
Ehime
ZIP/Postal Code
7910295
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
University of Occupational and Environmental Health, Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Local Institution - 0182
City
Isehara City
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2458575
Country
Japan
Facility Name
Local Institution - 0169
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Nakoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
University Hospital - Kyoto Preferctural University of Medicine
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Local Institution - 0166
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
7108602
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-Ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Local Institution - 0188
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Local Institution - 0175
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Local Institution - 0108
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Local Institution - 0167
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 0160
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Local Institution - 0187
City
Hwaseong-si
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Local Institution
City
Hwaseong-si
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Local Institution
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Local Institution - 0191
City
Warszawa
State/Province
MZ
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Local Institution - 0201
City
Bialystok
ZIP/Postal Code
15-077
Country
Poland
Facility Name
Local Institution - 0144
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Synexus - Katowice
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Local Institution - 0079
City
Krak
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Centrum Medyczne All-Med
City
Lodz
ZIP/Postal Code
94-048
Country
Poland
Facility Name
Miejski Szpital Zespolony w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
DermoDent - Centrum Medyczne Czajkowscy
City
Osielsko
ZIP/Postal Code
86-031
Country
Poland
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Local Institution - 0200
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Clinical Research Group
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Center for Clinical Studies - Texas Medical Center
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Lukasz Matusiak 4health
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
dermMedica Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Local Institution - 0203
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Local Institution - 0131
City
Ekaterinburg
ZIP/Postal Code
620076
Country
Russian Federation
Facility Name
Azbuka Zdorovya Medical Center
City
Kazan
ZIP/Postal Code
42011
Country
Russian Federation
Facility Name
Local Institution - 0172
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Local Institution - 0140
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
City
Moscow
ZIP/Postal Code
111398
Country
Russian Federation
Facility Name
State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Clinic of Skin Diseases of Pierre Wolkenstein
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Polyclinic of Private Security Personnel
City
Saint Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
City
Saint Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
Ars Vitae Multidisciplinary Medical Center
City
Saint Petersburg
ZIP/Postal Code
194223
Country
Russian Federation
Facility Name
Klinika Kozhnykh I Venericheskikh Bolezney
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Local Institution - 0121
City
Alcorcon
ZIP/Postal Code
28921
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar - Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Local Institution - 0097
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
10099
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
MAC Clinical Research - Blackpool
City
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
Synexus - Merseyside Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Guys and Saint Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Synexus - Manchester Clinical Research Centre
City
Manchester
ZIP/Postal Code
M15 6SE
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
MAC Clinical Research - Liverpool
City
Prescot
ZIP/Postal Code
L34 1BH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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