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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-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624127
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Other: Placebo Drug: Apremilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BMS-986165
BMS-986165 oral administration
Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo
Placebo oral administration
Other: Placebo
Specified dose on specified days

Active Comparator: Active comparator
Active comparator oral administration
Drug: Apremilast
Specified dose on specified days




Primary Outcome Measures :
  1. Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [ Time Frame: Baseline to Week 16 ]
    The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale.

  2. Percentage of participants who achieve PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Baseline to Week 16 ]
    The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).


Secondary Outcome Measures :
  1. Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 16 ]
  2. Percentage of participants who achieve PASI 100 [ Time Frame: Baseline to Week 16 ]
  3. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Baseline to Week 16 ]
    The PSSD is a participant questionnaire to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consists of 11 items covering various symptoms and patient-observable signs and averaged to generate a score from 0 (normal) to 10 (most severe).

  4. Percentage of participants who achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
    The ss-PGA measure is used to evaluate the overall disease severity of scalp psoriasis. Lesions are assessed by investigators in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 0 (normal) to 4 (severe) scale.

  5. Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline to Week 16 ]
    The DLQI is a 10-item participant questionnaire that measures the impact of skin disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 to 3 and added to generate a DLQI total score ranging from 0 (normal) to 30 (severe).

  6. Percentage of participants who achieve Physician Global Assessment-Fingernails (PGA-F) score 0 or 1 among participants with a baseline PGA-F score ≥3 [ Time Frame: Baseline to Week 16 ]
    The PGA-F score is a measure of the overall condition of the fingernails in participants who have psoriasis fingernail involvement. The nail bed and nail matrix of each fingernail are rated by the investigator on a 0 (normal) to 4 (severe) scale.

  7. Percentage of participants who achieve palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 among participants with a baseline pp- PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
    The pp-PGA score is a measure of the overall severity of psoriasis lesions involving the palms and soles. The investigator assesses overall severity based on a 0 (normal) to 4(severe) scale.

  8. Percentage of participants who achieve PASI 75 [ Time Frame: Baseline to Week 52 ]
  9. Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 52 ]
  10. Percentage of participants who achieve sPGA score of 0 or 1 response [ Time Frame: Baseline to Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624127


Locations
Hide Hide 165 study locations
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United States, Alabama
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
Coastal Clinical Research - Mobile
Mobile, Alabama, United States, 36608
United States, Arizona
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
Arizona Research Center
Phoenix, Arizona, United States, 85053
Synexus - Tucson
Tucson, Arizona, United States, 85741
United States, Arkansas
Hull Dermatology
Rogers, Arkansas, United States, 72758
United States, California
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
Fountain Valley, California, United States, 92708
University California at Irvine Dermatology Clinical Research Center
Irvine, California, United States, 92697
Keck School of Medicine
Los Angeles, California, United States, 90033
Dream Team Clinical Research
Pomona, California, United States, 91767
University Dermatology Group
San Diego, California, United States, 92123
Unison Clinical Trials
Sherman Oaks, California, United States, 91403
United States, Connecticut
New England Research Associates
Bridgeport, Connecticut, United States, 06606
United States, Florida
Precision Clinical Research
Davie, Florida, United States, 33328
Indago Research and Health Center
Hialeah, Florida, United States, 33012
San Marcus Research Clinic
Miami Lakes, Florida, United States, 33014
LCC Medical Research
Miami, Florida, United States, 33126
International Dermatology Research
Miami, Florida, United States, 33144
Well Pharma Medical Research
Miami, Florida, United States, 33173
Miami Dade Medical Research Institute
Miami, Florida, United States, 33176
Renstar Medical Research
Ocala, Florida, United States, 34471
Ameriderm Research
Ormond Beach, Florida, United States, 32174
Olympian Clinical Research - South Tampa Office
Tampa, Florida, United States, 33614-7118
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409-3401
United States, Georgia
Hamilton Dermatology
Alpharetta, Georgia, United States, 30022
Local Institution
Snellville, Georgia, United States, 30078
United States, Illinois
Healthcare Research Network - Flossmoor
Flossmoor, Illinois, United States, 60402
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
The Dermatology Center
New Albany, Indiana, United States, 47150
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
The South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kansas
Kansas City Dermatology
Overland Park, Kansas, United States, 66215
United States, Kentucky
Dermatology Specialists Research-Kentucky
Louisville, Kentucky, United States, 40241
United States, Louisiana
Clinical Trials of America - Monroe
Monroe, Louisiana, United States, 71201
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
United States, Massachusetts
ActivMed Practices and Research - Beverly
Beverly, Massachusetts, United States, 01915
DermCare Experts
Quincy, Massachusetts, United States, 02169
United States, Michigan
David Fivenson MD Dermatology
Ann Arbor, Michigan, United States, 48103
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Minnesota
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, New York
Forest Hills Dermatology Group
Kew Gardens, New York, United States, 11374
Mount Sinai - Queens
New York, New York, United States, 10023
United States, North Carolina
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
Duke University Health System - Duke Clinic
Durham, North Carolina, United States, 27710-4000
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43203
Synexus - Columbus
Columbus, Ohio, United States, 43212
United States, Oklahoma
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States, 73103-2433
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Synexus Clinical Research - Anderson
Anderson, South Carolina, United States, 29621
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
United States, Tennessee
Interspond - Stones River Dermatology - Murfreesboro Office
Murfreesboro, Tennessee, United States, 37129
United States, Texas
Westlake Dermatology - Westlake
Austin, Texas, United States, 78746
Dermatology Treatment and Research Center
Dallas, Texas, United States, 75230
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Austin Institute for Clinical Research - Pflugerville
Pflugerville, Texas, United States, 78660
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78218
Interspond - Acclaim Dermatology
Sugar Land, Texas, United States, 77479
Center for Clinical Studies - Webster
Webster, Texas, United States, 77598
United States, Washington
Dermatology Associates of Seattle
Seattle, Washington, United States, 98101
Eastern Washington Dermatology
Walla Walla, Washington, United States, 99362
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Canada, Manitoba
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Office of Dr. Arnon Moshe Katz
Newmarket, Ontario, Canada, L3Y 6P5
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada, L6J 7W5
Skin Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology - Richmond Hill
Richmond Hill, Ontario, Canada, L4B 1A5
XLR8 Medical Research
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Docteur David Gratton Dermatologue
Montreal, Quebec, Canada, H3H 1V4
Siena Medical Research
Montreal, Quebec, Canada, H3Z 2S6
Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Quebec, Canada, G1V 4X7
China, Beijing
Local Institution
Beijing, Beijing, China, 100050
China, Hubei
Local Institution
Wuhan, Hubei, China, 430030
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310009
Germany
Charite Universitatsmedizin Berlin
Berlin, Germany, 10117
Klinische Forschung Dresden GmbH
Dresden, Germany, 01069
Japan
Nagoya City University Hospital
Nagoya, Aichi, Japan, 467-8602
Ehime University Hospital
Toon-Shi, Ehime, Japan, 791-0295
Fukuoka University Hospital
Fukuoka-shi, Fukuoka, Japan, 814-0180
University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan, 807-8555
Sapporo Skin Clinic
Sapporo, Hokkaido, Japan, 060-0063
Kobe University Hospital
Kobe, Hyogo, Japan, 6500017
Tokai University Hospital
Isehara City, Kanagawa, Japan, 259-1193
National Hospital Organization Yokohama Medical Center
Yokohama-shi, Kanagawa, Japan, 2458575
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Kochi Medical School Hospital
Nakoku, Kochi, Japan, 783-8505
University Hospital - Kyoto Preferctural University of Medicine
Kyoto-city, Kyoto, Japan, 602-8566
Mie University Hospital
Tsu, MIE, Japan, 514-8507
Shinshu University Hospital
Matsumoto, Nagano, Japan, 3908621
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 7108602
Osaka City University Hospital
Osaka-shi, Osaka, Japan, 5458586
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan, 173-8606
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
The Jikei University Hospital
Minato-ku, Tokyo, Japan, 105-8471
NTT Medical Center Tokyo
Shinagawa, Tokyo, Japan, 141-8625
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan, 169-0073
Japan Community Health Care Organization Tokyo Yamate Medical Center
Shinjuku, Tokyo, Japan, 169-0073
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kyoto University Hospital
Kyoto, Japan, 606-8507
Nippon Life Hospital
Osaka, Japan, 550-0006
Korea, Republic of
Local Institution
Busan, Korea, Republic of, 49241
Local Institution
Hwaseong-si, Korea, Republic of, 18450
Local Institution
Incheon, Korea, Republic of, 21565
Local Institution
Seongnam-si, Korea, Republic of, 13620
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 137-701
Local Institution
Seoul, Korea, Republic of, 660-702
Poland
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Poland, 15-099
Synexus Polska Oddzial w Gdyni
Gdynia, Poland, 81-537
Synexus - Katowice
Katowice, Poland, 40-040
Pratia MCM Krakow
Krak, Poland, 30-510
Centrum Terapii Wspolczesnej
Lodz, Poland, 90-242
Centrum Medyczne All-Med
Lodz, Poland, 94-048
Miejski Szpital Zespolony w Olsztynie
Olsztyn, Poland, 10-229
DermoDent - Centrum Medyczne Czajkowscy
Osielsko, Poland, 86-031
Solumed Centrum Medyczne
Poznan, Poland, 60-529
Centrum Badan Klinicznych S.C.
Poznan, Poland, 60-773
Clinical Research Group
Warszawa, Poland, 01-142
Royalderm Agnieszka Nawrocka
Warszawa, Poland, 02-962
Center for Clinical Studies - Texas Medical Center
Wroclaw, Poland, 50-367
Lukasz Matusiak 4health
Wroclaw, Poland, 50-566
dermMedica Sp. z o.o.
Wroclaw, Poland, 51-318
WroMedica
Wroclaw, Poland, 51-685
Russian Federation
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Ekaterinburg, Russian Federation, 620076
Azbuka Zdorovya Medical Center
Kazan, Russian Federation, 42011
SBHI Clinical Skin and Venereology Dispensary of the Ministry of Health of Krasnodar Region
Krasnodar, Russian Federation, 350020
NIARMEDIK - Clinic on Clinic on Kitai Gorod
Moscow, Russian Federation, 101000
Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
Moscow, Russian Federation, 111398
State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
Ryazan, Russian Federation, 390046
Clinic of Skin Diseases of Pierre Wolkenstein
Saint Petersburg, Russian Federation, 191123
Polyclinic of Private Security Personnel
Saint Petersburg, Russian Federation, 192007
Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
Saint Petersburg, Russian Federation, 194021
Ars Vitae Multidisciplinary Medical Center
Saint Petersburg, Russian Federation, 194223
Klinika Kozhnykh I Venericheskikh Bolezney
Saratov, Russian Federation, 410028
Smolensk State Medical University
Smolensk, Russian Federation, 214019
MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
Yaroslavl, Russian Federation, 150003
Spain
Hospital Universitario Fundacion Alcorcon
Alcorcon, Spain, 28922
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitario Cruces
Barakaldo, Spain, 48903
Hospital del Mar - Parc de Salut Mar
Barcelona, Spain, 08003
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Taiwan
Local Institution
Kaohsiung, Taiwan, 81362
Local Institution
Taipei, Taiwan, 10099
Local Institution
Taipei, Taiwan, 11217
United Kingdom
MAC Clinical Research - Blackpool
Lancashire, United Kingdom, FY2 0JH
Synexus - Merseyside Clinical Research Centre
Liverpool, United Kingdom, L22 0LG
Guys and Saint Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Synexus - Manchester Clinical Research Centre
Manchester, United Kingdom, M15 6SE
Salford Royal NHS Foundation Trust
Manchester, United Kingdom, M6 8HD
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, United Kingdom, NE1 4LP
MAC Clinical Research - Liverpool
Prescot, United Kingdom, L34 1BH
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03624127    
Other Study ID Numbers: IM011-046
2018-001926-25 ( EudraCT Number )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
BMS-986165
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action