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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)

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 could apply

Sites / Locations

  • Total Skin and Beauty Dermatology Center
  • The Kirklin Clinic of UAB Hospital
  • Alliance Dermatology and Mohs Center - Phoenix
  • Clinical Research Consortium - Tempe
  • Johnson Dermatology
  • Burke Pharmaceutical Research
  • Applied Research Center of Arkansas
  • Anaheim Clinical Trials
  • Center for Dermatology Clinical Research
  • Associates in Research, Inc.
  • Marvel Clinical Research
  • Interspond - Long Beach Clinical Trials
  • Dermatology Research Associates - Los Angeles
  • LA Universal Research Center
  • Artemis Institute for Clinical Research - San Diego
  • University of California San Diego Health Systems
  • Therapeutics Clinical Research
  • San Luis Dermatology and Laser Clinic
  • Artemis Institute for Clinical Research - San Marcos
  • West Coast Research
  • Clinical Science Institute
  • Synexus - Santa Rosa
  • Care Access Research - Walnut Creek
  • Stamford Therapeutics Consortium
  • Skin Care Research
  • ERN - Accel Research - Avail
  • Interspond - Savin Medical Group
  • Synexus Clinical Research - Saint Petersburg
  • Progressive Medical Research
  • Precision Clinical Research - Corporate Office
  • Precision Clinical Research - Corporate Office
  • Moore Clinical Research - South Tampa
  • University of South Florida/USF Health
  • ForCare Clinical Research
  • Marietta Dermatology & The Skin Cancer Center
  • Advanced Clinical Research - Idaho
  • Glazer Dermatology
  • Southern Illinois University School of Medicine
  • Dundee Dermatology
  • Dermatology Center of Northwest Indiana
  • Synexus - Evansville South
  • Dawes Fretzin Dermatology Group
  • Skin Sciences
  • Advanced Medical Research
  • Shondra L. Smith, M.D.
  • DelRicht Research - New Orleans - Prytania Street
  • Ora
  • Tufts Medical Center
  • Beth Israel Deaconess Medical Center
  • Brigham Dermatology Associates
  • A. Alfred Taubman Health Care Center
  • Hamzavi Dermatology
  • Washington University School of Medicine - West County Dermatology
  • Healthcare Research Network - Hazelwood
  • Clinical Research Consortium - Las Vegas
  • ActivMed Practices and Research - Portsmouth
  • Windsor Dermatology
  • Montefiore Medical Center
  • Sadick Research Group
  • DermResearch Center of New York
  • PMG Research of Cary
  • Dermatology Consulting Services
  • Wilmington Dermatology Center
  • Synexus - Cincinnati
  • University Hospitals Case Medical Center
  • ClinOhio Research Services
  • Wright State Research Institute
  • Central Sooner Research
  • Unity Clinical Research
  • Oregon Dermatology and Research Center
  • Dermatology and Skin Surgery Center - Exton
  • Paddington Testing Company
  • Synexus
  • Coastal Carolina Research Center - Mount Pleasant
  • Health Concepts
  • Rivergate Dermatology - Main Office
  • Clinical Research Solutions - Jackson
  • Dermatology Associates of Knoxville
  • The Skin Wellness Center
  • Arlington Center for Dermatology
  • DermResearch
  • Bellaire Dermatology
  • Modern Research Associates
  • Synexus - Dallas
  • Progressive Clinical Research - San Antonio
  • Dermatology Clinical Research Center of San Antonio
  • Interspond - Houston Center for Clinical Research
  • West Virginia University
  • Medical College of Wisconsin
  • Woden Dermatology
  • Holdsworth House Medical Practice
  • St. George Dermatology & Skin Care Centre
  • Westmead Hospital
  • The Skin Centre
  • Veracity Clinical Research
  • North Eastern Health Specialists
  • Box Hill Hospital
  • Skin and Cancer Foundation
  • Sinclair Dermatology
  • The Royal Melbourne Hospital
  • Fremantle Dermatology
  • Institute for Skin Advancement
  • Stratica Medical
  • University of British Columbia
  • CCA Medical Research
  • Mediprobe Research
  • DermEffects
  • Lynderm Research
  • DermEdge
  • York Dermatology Clinic and Research Centre
  • Office of Dr. Niakosari Firouzeh
  • Dermatology Ottawa Research Centre
  • Toronto Dermatology Centre
  • Dermatology on Bloor
  • Kim Papp Clinical Research
  • Dr. Isabelle Delorme
  • Innovaderm Research
  • Nemocnice Jihlava
  • Nemocnice Novy Jicin a.s.
  • MUDr. Helena Korandova
  • Fakultni Nemocnice Ostrava
  • Clintrial
  • Sanatorium profesora Arenbergera
  • Kozni a zilni ambulance
  • Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
  • Terveystalo Tampere
  • Mehilainen Turku
  • Local Institution - 0197
  • Hopital Prive dAntony
  • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
  • Centre Hospitalier Universitaire de Nice Hopital lArchet
  • Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
  • Local Institution - 0128
  • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
  • Hautarztpraxis Dr. Beatrice Gerlach
  • Local Institution - 0246
  • Local Institution - 0119
  • Medizinische Hochschule Hannover
  • Dermakiel - Allergie Und Haut Centrum
  • Praxis Dr. Beate Schwarz
  • Universitatsklinikum Schleswig-Holstein - Campus Lubeck
  • Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
  • Harzklinikum Dorothea Christiane Erxleben
  • Praxis Dr. med. Wilfried Steinborn
  • CentroDerm GmbH
  • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
  • Synexus Magyarorszag
  • Semmelweis Egyetem
  • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
  • Debreceni Egyetem Klinikai Kozpont
  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
  • Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudomanyegyetem
  • Allergo-Derm Bakos
  • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
  • Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
  • Local Institution
  • Local Institution
  • Local Institution
  • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
  • ClinicMed Daniluk Nowak Spolka Jawna
  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Synexus Polska Oddzial w Gdansk
  • Zespol Naukowo-Leczniczy Iwolang
  • Krakowskie Centrum Medyczne
  • Dermed Centrum Medyczne
  • Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
  • Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
  • ETG - Siedlce
  • ETG - Skierniewice
  • Local Institution - 0142
  • Klinika Ambroziak
  • High-Med Przychodnia Specjalistyczna
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • ETG - Warszawa
  • Local Institution - 0183
  • GCM Medical Group
  • Local Institution - 0156
  • Hospital Universitario de Vinalopo
  • Hospital Universitario de Gran Canaria Doctor Negrin
  • Hospital Universitario Ramon Y Cajal
  • Hospital de Manises
  • Hospital Universitario Virgen de la Victoria
  • Local Institution - 0137
  • Burbage Surgery
  • Consorci Hospital General Universitari de Valencia
  • Ladulaas Kliniska Studier
  • Pharmasite - Helsingborg
  • ProbarE i Lund
  • PharmaSite - Malmo
  • Karolinska Universitetssjukhuset
  • MAC Clinical Research - Cannock
  • Ashgate Medical Practice
  • Local Institution - 0189
  • Mounts Bay Medical
  • The Dudley Group NHS Foundation Trust
  • MAC Clinical Research - Stockton
  • The Leeds Teaching Hospitals NHS Trust
  • MAC Clinical Research - Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

BMS-986165

Placebo

Active comparator

Arm Description

BMS-986165 oral administration

Placebo oral administration

Active comparator oral administration

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 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.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Secondary Outcome Measures

The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0). A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 . Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline. The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.

Full Information

First Posted
July 25, 2018
Last Updated
November 26, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03611751
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Acronym
POETYK-PSO-2
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
November 29, 2020 (Actual)
Study Completion Date
November 30, 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
1020 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165
Arm Type
Experimental
Arm Description
BMS-986165 oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral administration
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Active comparator oral administration
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 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.
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
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.
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 Score at Week 16 (PASI 90)
Description
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.
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 Score at Week 16 (PASI 100)
Description
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.
Time Frame
Baseline and Week 16
Title
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
Description
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.
Time Frame
Week 16
Title
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Description
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.
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
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.
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
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.
Time Frame
Week 16
Title
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)
Description
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.
Time Frame
Week 16
Title
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)
Description
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.
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
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.
Time Frame
Baseline and Week 16
Title
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)
Description
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.
Time Frame
Week 16
Title
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Description
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.
Time Frame
From Week 24 to Week 52 (up to approximately 28 weeks)
Title
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)
Description
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.
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 Apremalist at Week 24 (PASI 75)
Description
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.
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 Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
Description
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.
Time Frame
Baseline 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 could 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
Total Skin and Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
The Kirklin Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alliance Dermatology and Mohs Center - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Clinical Research Consortium - Tempe
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Associates in Research, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Interspond - Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Dermatology Research Associates - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045-3606
Country
United States
Facility Name
LA Universal Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Artemis Institute for Clinical Research - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California San Diego Health Systems
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Luis Dermatology and Laser Clinic
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Artemis Institute for Clinical Research - San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
West Coast Research
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Synexus - Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Care Access Research - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Skin Care Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
ERN - Accel Research - Avail
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Interspond - Savin Medical Group
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Synexus Clinical Research - Saint Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Precision Clinical Research - Corporate Office
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Precision Clinical Research - Corporate Office
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Moore Clinical Research - South Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida/USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Marietta Dermatology & The Skin Cancer Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advanced Clinical Research - Idaho
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Glazer Dermatology
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Dermatology Center of Northwest Indiana
City
Crown Point
State/Province
Indiana
ZIP/Postal Code
46307
Country
United States
Facility Name
Synexus - Evansville South
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Dawes Fretzin Dermatology Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Skin Sciences
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Advanced Medical Research
City
Lacombe
State/Province
Louisiana
ZIP/Postal Code
70445
Country
United States
Facility Name
Shondra L. Smith, M.D.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605-1213
Country
United States
Facility Name
DelRicht Research - New Orleans - Prytania Street
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ora
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham Dermatology Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
A. Alfred Taubman Health Care Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Washington University School of Medicine - West County Dermatology
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Healthcare Research Network - Hazelwood
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Clinical Research Consortium - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
ActivMed Practices and Research - Portsmouth
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Windsor Dermatology
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
DermResearch Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Synexus - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
ClinOhio Research Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Wright State Research Institute
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dermatology and Skin Surgery Center - Exton
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Paddington Testing Company
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Synexus
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Coastal Carolina Research Center - Mount Pleasant
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Rivergate Dermatology - Main Office
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Clinical Research Solutions - Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Dermatology Associates of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Bellaire Dermatology
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Synexus - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Progressive Clinical Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213-2250
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Interspond - Houston Center for Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. George Dermatology & Skin Care Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
North Eastern Health Specialists
City
Hectorville
State/Province
South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Skin and Cancer Foundation
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Mediprobe Research
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
York Dermatology Clinic and Research Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Office of Dr. Niakosari Firouzeh
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
Toronto Dermatology Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Dermatology on Bloor
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
Kim Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Dr. Isabelle Delorme
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L5
Country
Canada
Facility Name
Innovaderm Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Nemocnice Jihlava
City
Jihlava 1
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Nemocnice Novy Jicin a.s.
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
MUDr. Helena Korandova
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Clintrial
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Sanatorium profesora Arenbergera
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Kozni a zilni ambulance
City
Usti nad Labem
ZIP/Postal Code
400 10
Country
Czechia
Facility Name
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Mehilainen Turku
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Local Institution - 0197
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Facility Name
Hopital Prive dAntony
City
Antony
ZIP/Postal Code
92160
Country
France
Facility Name
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice Hopital lArchet
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0128
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Hautarztpraxis Dr. Beatrice Gerlach
City
Dresden
ZIP/Postal Code
01097
Country
Germany
Facility Name
Local Institution - 0246
City
Frankfurt am Main
ZIP/Postal Code
60313
Country
Germany
Facility Name
Local Institution - 0119
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dermakiel - Allergie Und Haut Centrum
City
Kiel
ZIP/Postal Code
24148
Country
Germany
Facility Name
Praxis Dr. Beate Schwarz
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
City
Munchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Harzklinikum Dorothea Christiane Erxleben
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Praxis Dr. med. Wilfried Steinborn
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
CentroDerm GmbH
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany
Facility Name
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Magyarorszag
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Allergo-Derm Bakos
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Local Institution
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Local Institution
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution
City
Hamilton
ZIP/Postal Code
3206
Country
New Zealand
Facility Name
Local Institution
City
Mount Cook
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Local Institution
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ClinicMed Daniluk Nowak Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Synexus Polska Oddzial w Gdansk
City
Gda?sk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Zespol Naukowo-Leczniczy Iwolang
City
Iwonicz-Zdroj
ZIP/Postal Code
38-440
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Dermed Centrum Medyczne
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
City
Lublin
ZIP/Postal Code
20-406
Country
Poland
Facility Name
ETG - Siedlce
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
ETG - Skierniewice
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Local Institution - 0142
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Klinika Ambroziak
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
High-Med Przychodnia Specjalistyczna
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
City
Warszawa
ZIP/Postal Code
02-008
Country
Poland
Facility Name
ETG - Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Local Institution - 0183
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
GCM Medical Group
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Facility Name
Local Institution - 0156
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario de Vinalopo
City
Elche
ZIP/Postal Code
03293
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital de Manises
City
Manises
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Mߧa
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0137
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Burbage Surgery
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Consorci Hospital General Universitari de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Ladulaas Kliniska Studier
City
Boras
ZIP/Postal Code
506 30
Country
Sweden
Facility Name
Pharmasite - Helsingborg
City
Helsingborg
ZIP/Postal Code
25200
Country
Sweden
Facility Name
ProbarE i Lund
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
PharmaSite - Malmo
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Solna
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
MAC Clinical Research - Cannock
City
Cannock
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Ashgate Medical Practice
City
Chesterfield
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Local Institution - 0189
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Mounts Bay Medical
City
Cornwall
ZIP/Postal Code
TR27 5DT
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
MAC Clinical Research - Stockton
City
Durham
ZIP/Postal Code
TS17 6EW
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
MAC Clinical Research - Manchester
City
Manchester
ZIP/Postal Code
M13 9NQ
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

Learn more about this trial

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

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