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
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
2 other identifiers
interventional
1,020
16 countries
205
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2018
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedResults Posted
Study results publicly available
December 20, 2022
CompletedDecember 20, 2022
October 1, 2022
2.3 years
July 25, 2018
October 6, 2022
November 26, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Week 16
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Baseline and Week 16
Secondary Outcomes (15)
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
Baseline and Week 16
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
Baseline and Week 16
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
Baseline and Week 16
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Week 16
- +10 more secondary outcomes
Study Arms (3)
BMS-986165
EXPERIMENTALBMS-986165 oral administration
Placebo
PLACEBO COMPARATORPlacebo oral administration
Active comparator
ACTIVE COMPARATORActive comparator oral administration
Interventions
Eligibility Criteria
You may qualify if:
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
You may not qualify if:
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165 or active comparator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (205)
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205, United States
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
Alliance Dermatology and Mohs Center - Phoenix
Phoenix, Arizona, 85032, United States
Clinical Research Consortium - Tempe
Tempe, Arizona, 85283, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
Associates in Research, Inc.
Fresno, California, 93720, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Interspond - Long Beach Clinical Trials
Long Beach, California, 90806, United States
Dermatology Research Associates - Los Angeles
Los Angeles, California, 90045-3606, United States
LA Universal Research Center
Los Angeles, California, 90057, United States
Artemis Institute for Clinical Research - San Diego
San Diego, California, 92103, United States
University of California San Diego Health Systems
San Diego, California, 92122, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, 93405, United States
Artemis Institute for Clinical Research - San Marcos
San Marcos, California, 92078, United States
West Coast Research
San Ramon, California, 94582, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Synexus - Santa Rosa
Santa Rosa, California, 95405, United States
Care Access Research - Walnut Creek
Walnut Creek, California, 94598, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Skin Care Research
Boca Raton, Florida, 33486, United States
ERN - Accel Research - Avail
DeLand, Florida, 32720, United States
Interspond - Savin Medical Group
Miami Lakes, Florida, 33014, United States
Synexus Clinical Research - Saint Petersburg
Pinellas Park, Florida, 33781, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Precision Clinical Research - Corporate Office
Sunrise, Florida, 33351, United States
Precision Clinical Research - Corporate Office
Tamarac, Florida, 33351, United States
Moore Clinical Research - South Tampa
Tampa, Florida, 33609, United States
University of South Florida/USF Health
Tampa, Florida, 33612, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Marietta Dermatology & The Skin Cancer Center
Marietta, Georgia, 30060, United States
Advanced Clinical Research - Idaho
Meridian, Idaho, 83642, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Dermatology Center of Northwest Indiana
Crown Point, Indiana, 46307, United States
Synexus - Evansville South
Evansville, Indiana, 47714, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46250, United States
Skin Sciences
Louisville, Kentucky, 40217, United States
Advanced Medical Research
Lacombe, Louisiana, 70445, United States
Shondra L. Smith, M.D.
Lake Charles, Louisiana, 70605-1213, United States
DelRicht Research - New Orleans - Prytania Street
New Orleans, Louisiana, 70115, United States
Ora
Andover, Massachusetts, 01810, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Brigham Dermatology Associates
Boston, Massachusetts, 02115, United States
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Washington University School of Medicine - West County Dermatology
Creve Coeur, Missouri, 63141, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, 63042, United States
Clinical Research Consortium - Las Vegas
Las Vegas, Nevada, 89119, United States
ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire, 03801, United States
Windsor Dermatology
East Windsor, New Jersey, 08520, United States
Sadick Research Group
New York, New York, 10075, United States
DermResearch Center of New York
Stony Brook, New York, 11790, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
PMG Research of Cary
Cary, North Carolina, 27615, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28405, United States
Synexus - Cincinnati
Cincinnati, Ohio, 45249, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
ClinOhio Research Services
Columbus, Ohio, 43213, United States
Wright State Research Institute
Fairborn, Ohio, 45324, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology and Skin Surgery Center - Exton
Exton, Pennsylvania, 19341, United States
Paddington Testing Company
Philadelphia, Pennsylvania, 19103, United States
Synexus
Greer, South Carolina, 29651, United States
Coastal Carolina Research Center - Mount Pleasant
Mt. Pleasant, South Carolina, 29464, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Rivergate Dermatology - Main Office
Goodlettsville, Tennessee, 37072, United States
Clinical Research Solutions - Jackson
Jackson, Tennessee, 38305, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Arlington Center for Dermatology
Arlington, Texas, 76011, United States
DermResearch
Austin, Texas, 78759, United States
Bellaire Dermatology
Bellaire, Texas, 77401, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Synexus - Dallas
Dallas, Texas, 75234, United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, 78213-2250, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Interspond - Houston Center for Clinical Research
Sugar Land, Texas, 77479, United States
West Virginia University
Morgantown, West Virginia, 26501, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
St. George Dermatology & Skin Care Centre
Kogarah, New South Wales, 2217, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
North Eastern Health Specialists
Hectorville, South Australia, 5073, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Skin and Cancer Foundation
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Institute for Skin Advancement
Calgary, Alberta, T3E 0B2, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
University of British Columbia
Vancouver, British Columbia, V5Z 4E8, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
Mediprobe Research
London, Ontario, N5X 2P1, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research
Markham, Ontario, L3P 1X2, Canada
DermEdge
Mississauga, Ontario, L5H 1G9, Canada
York Dermatology Clinic and Research Centre
Mississauga, Ontario, L5H 1G9, Canada
Office of Dr. Niakosari Firouzeh
North York, Ontario, M2M 4J5, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2, Canada
Toronto Dermatology Centre
Toronto, Ontario, M3H 5Y8, Canada
Dermatology on Bloor
Toronto, Ontario, M4W 2N4, Canada
Kim Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Dr. Isabelle Delorme
Drummondville, Quebec, J2B 5L5, Canada
Innovaderm Research
Montreal, Quebec, H2X 2V1, Canada
Nemocnice Jihlava
Jihlava, 586 01, Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, 741 01, Czechia
MUDr. Helena Korandova
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
Clintrial
Prague, 100 00, Czechia
Sanatorium profesora Arenbergera
Prague, 110 00, Czechia
Kozni a zilni ambulance
Ústí nad Labem, 400 10, Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, 401 13, Czechia
Terveystalo Tampere
Tampere, 33100, Finland
Mehilainen Turku
Turku, 20100, Finland
Local Institution - 0197
Vaasa, 65130, Finland
Hopital Prive dAntony
Antony, 92160, France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, 29609, France
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice, 06202, France
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
Toulouse, 31059, France
Local Institution - 0128
Augsburg, 86179, Germany
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum, 44793, Germany
Hautarztpraxis Dr. Beatrice Gerlach
Dresden, 01097, Germany
Local Institution - 0246
Frankfurt am Main, 60313, Germany
Local Institution - 0119
Hamburg, 20253, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Dermakiel - Allergie Und Haut Centrum
Kiel, 24148, Germany
Praxis Dr. Beate Schwarz
Langenau, 89129, Germany
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
Lübeck, 23538, Germany
Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
München, 80802, Germany
Harzklinikum Dorothea Christiane Erxleben
Quedlinburg, 06484, Germany
Praxis Dr. med. Wilfried Steinborn
Straubing, 94315, Germany
CentroDerm GmbH
Wuppertal, 42287, Germany
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest, 1036, Hungary
Synexus Magyarorszag
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1085, Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
Debrecen, 4025, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
Gyula, 5700, Hungary
Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Allergo-Derm Bakos
Szolnok, 5000, Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
Zalaegerszeg, 8900, Hungary
Local Institution
Haifa, 3436212, Israel
Local Institution
Kfar Saba, 4428164, Israel
Local Institution
Petah Tikva, 49100, Israel
Local Institution
Ramat Gan, 52621, Israel
Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
Pisa, 56126, Italy
Local Institution
Hamilton, 3206, New Zealand
Local Institution
Mount Cook, 6021, New Zealand
Local Institution
Tauranga, 3110, New Zealand
ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, 15-351, Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok, 15-879, Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300, Poland
Synexus Polska Oddzial w Gdansk
Gda?sk, 80-382, Poland
Zespol Naukowo-Leczniczy Iwolang
Iwonicz-Zdrój, 38-440, Poland
Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
Dermed Centrum Medyczne
Lodz, 90-265, Poland
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436, Poland
Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
Lublin, 20-406, Poland
ETG - Siedlce
Siedlce, 08-110, Poland
ETG - Skierniewice
Skierniewice, 96-100, Poland
Local Institution - 0142
Torun, 87-100, Poland
High-Med Przychodnia Specjalistyczna
Warsaw, 01-817, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-008, Poland
ETG - Warszawa
Warsaw, 02-793, Poland
Klinika Ambroziak
Warsaw, 02-953, Poland
Local Institution - 0183
Wroclaw, 52-416, Poland
GCM Medical Group
San Juan, 917, Puerto Rico
Local Institution - 0156
Córdoba, 14004, Spain
Hospital Universitario de Vinalopo
Elche, 03293, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital de Manises
Manises, 46940, Spain
Hospital Universitario Virgen de la Victoria
Mߧa, 29010, Spain
Local Institution - 0137
Pozuelo de Alarcón, 28223, Spain
Burbage Surgery
Santiago de Compostela, 15706, Spain
Consorci Hospital General Universitari de Valencia
Valencia, 46014, Spain
Ladulaas Kliniska Studier
Borås, 506 30, Sweden
Pharmasite - Helsingborg
Helsingborg, 25200, Sweden
ProbarE i Lund
Lund, 22222, Sweden
PharmaSite - Malmo
Malmo, 211 52, Sweden
Karolinska Universitetssjukhuset
Solna, 171 76, Sweden
MAC Clinical Research - Cannock
Cannock, WS11 0BN, United Kingdom
Ashgate Medical Practice
Chesterfield, S40 4AA, United Kingdom
Local Institution - 0189
Chorley, PR7 7NA, United Kingdom
Mounts Bay Medical
Cornwall, TR27 5DT, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, DY1 2HQ, United Kingdom
MAC Clinical Research - Stockton
Durham, TS17 6EW, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, LS7 4SA, United Kingdom
MAC Clinical Research - Manchester
Manchester, M13 9NQ, United Kingdom
Related Publications (6)
Armstrong AW, Warren RB, Sofen H, Spelman L, Linaberry M, Becker B, Jou YM, Daamen C, Kimball AB. Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis. Dermatol Ther (Heidelb). 2025 Dec 5. doi: 10.1007/s13555-025-01606-9. Online ahead of print.
PMID: 41350512DERIVEDMerola JF, Mease PJ, Armstrong AW, Strand V, Lehman T, Varga S, Choi JC, Becker B, Zhong Y, Colombo MJ, Thaci D, Bili A, Gottlieb AB. Deucravacitinib in Patients with Plaque Psoriasis Who Screened Positive for Psoriatic Arthritis: Improvements in Joint Pain and the Impact of Musculoskeletal Symptoms. Dermatol Ther (Heidelb). 2025 Aug;15(8):2281-2293. doi: 10.1007/s13555-025-01428-9. Epub 2025 May 30.
PMID: 40445270DERIVEDArmstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.
PMID: 40113724DERIVEDArmstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.
PMID: 39602111DERIVEDArmstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.
PMID: 39080153DERIVEDStrober B, Thaci D, Sofen H, Kircik L, Gordon KB, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp KA. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy. 2023 Aug;15(11):787-797. doi: 10.2217/imt-2023-0062. Epub 2023 May 7.
PMID: 37150956DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 2, 2018
Study Start
July 26, 2018
Primary Completion
November 29, 2020
Study Completion
November 30, 2020
Last Updated
December 20, 2022
Results First Posted
December 20, 2022
Record last verified: 2022-10