POETYK-PSO-2: 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
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03611751
Collaborator
(none)
1,020
205
3
28.2
5
0.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1020 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 With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date
:
Jul 26, 2018
Actual Primary Completion Date
:
Nov 30, 2020
Actual Study Completion Date
:
Nov 30, 2020
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Static Physician's Global Assessment (sPGA) score of 0 or 1 [Week 16]
- PASI 75 (75% reduction in Psoriasis Area and Severity Index) [Week 16]
Secondary Outcome Measures
- PASI 90 [Week 16]
- PASI 100 [Week 16]
- Psoriasis Symptoms and Signs Diary (PSSD) score [Week 16]
- Scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 [Week 16]
- Dermatology Life Quality Index (DLQI) score [Week 16]
- Physician Global Assessment- Fingernails (PGA-F) score 0 or 1 [Week 16]
- Palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 [Week 16]
- Maintenance of PASI 75 [Week 52]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Total Skin and Beauty Dermatology Center | Birmingham | Alabama | United States | 35205 |
| 2 | The Kirklin Clinic of UAB Hospital | Birmingham | Alabama | United States | 35233 |
| 3 | Alliance Dermatology and Mohs Center - Phoenix | Phoenix | Arizona | United States | 85032 |
| 4 | Clinical Research Consortium - Tempe | Tempe | Arizona | United States | 85283 |
| 5 | Johnson Dermatology | Fort Smith | Arkansas | United States | 72916 |
| 6 | Burke Pharmaceutical Research | Hot Springs | Arkansas | United States | 71913 |
| 7 | Applied Research Center of Arkansas | Little Rock | Arkansas | United States | 72212 |
| 8 | Anaheim Clinical Trials | Anaheim | California | United States | 92801 |
| 9 | Center for Dermatology Clinical Research | Fremont | California | United States | 94538 |
| 10 | Associates in Research, Inc. | Fresno | California | United States | 93720 |
| 11 | Marvel Clinical Research | Huntington Beach | California | United States | 92647 |
| 12 | Interspond - Long Beach Clinical Trials | Long Beach | California | United States | 90806 |
| 13 | Dermatology Research Associates - Los Angeles | Los Angeles | California | United States | 90045-3606 |
| 14 | LA Universal Research Center | Los Angeles | California | United States | 90057 |
| 15 | Artemis Institute for Clinical Research - San Diego | San Diego | California | United States | 92103 |
| 16 | University of California San Diego Health Systems | San Diego | California | United States | 92122 |
| 17 | Therapeutics Clinical Research | San Diego | California | United States | 92123 |
| 18 | San Luis Dermatology and Laser Clinic | San Luis Obispo | California | United States | 93405 |
| 19 | Artemis Institute for Clinical Research - San Marcos | San Marcos | California | United States | 92078 |
| 20 | West Coast Research | San Ramon | California | United States | 94582 |
| 21 | Clinical Science Institute | Santa Monica | California | United States | 90404 |
| 22 | Synexus - Santa Rosa | Santa Rosa | California | United States | 95405 |
| 23 | Care Access Research - Walnut Creek | Walnut Creek | California | United States | 94598 |
| 24 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 25 | Skin Care Research | Boca Raton | Florida | United States | 33486 |
| 26 | ERN - Accel Research - Avail | DeLand | Florida | United States | 32720 |
| 27 | Interspond - Savin Medical Group | Miami Lakes | Florida | United States | 33014 |
| 28 | Synexus Clinical Research - Saint Petersburg | Pinellas Park | Florida | United States | 33781 |
| 29 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 30 | Precision Clinical Research - Corporate Office | Sunrise | Florida | United States | 33351 |
| 31 | Precision Clinical Research - Corporate Office | Tamarac | Florida | United States | 33351 |
| 32 | Moore Clinical Research - South Tampa | Tampa | Florida | United States | 33609 |
| 33 | University of South Florida/USF Health | Tampa | Florida | United States | 33612 |
| 34 | ForCare Clinical Research | Tampa | Florida | United States | 33613 |
| 35 | Marietta Dermatology & The Skin Cancer Center | Marietta | Georgia | United States | 30060 |
| 36 | Advanced Clinical Research - Idaho | Meridian | Idaho | United States | 83642 |
| 37 | Glazer Dermatology | Buffalo Grove | Illinois | United States | 60089 |
| 38 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 39 | Dundee Dermatology | West Dundee | Illinois | United States | 60118 |
| 40 | Dermatology Center of Northwest Indiana | Crown Point | Indiana | United States | 46307 |
| 41 | Synexus - Evansville South | Evansville | Indiana | United States | 47714 |
| 42 | Dawes Fretzin Dermatology Group | Indianapolis | Indiana | United States | 46250 |
| 43 | Skin Sciences | Louisville | Kentucky | United States | 40217 |
| 44 | Advanced Medical Research | Lacombe | Louisiana | United States | 70445 |
| 45 | Shondra L. Smith, M.D. | Lake Charles | Louisiana | United States | 70605-1213 |
| 46 | DelRicht Research - New Orleans - Prytania Street | New Orleans | Louisiana | United States | 70115 |
| 47 | Ora | Andover | Massachusetts | United States | 01810 |
| 48 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 49 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
| 50 | Brigham Dermatology Associates | Boston | Massachusetts | United States | 02115 |
| 51 | A. Alfred Taubman Health Care Center | Ann Arbor | Michigan | United States | 48109 |
| 52 | Hamzavi Dermatology | Fort Gratiot | Michigan | United States | 48059 |
| 53 | Washington University School of Medicine - West County Dermatology | Creve Coeur | Missouri | United States | 63141 |
| 54 | Healthcare Research Network - Hazelwood | Hazelwood | Missouri | United States | 63042 |
| 55 | Clinical Research Consortium - Las Vegas | Las Vegas | Nevada | United States | 89119 |
| 56 | ActivMed Practices and Research - Portsmouth | Portsmouth | New Hampshire | United States | 03801 |
| 57 | Windsor Dermatology | East Windsor | New Jersey | United States | 08520 |
| 58 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 59 | Sadick Research Group | New York | New York | United States | 10075 |
| 60 | DermResearch Center of New York | Stony Brook | New York | United States | 11790 |
| 61 | PMG Research of Cary | Cary | North Carolina | United States | 27615 |
| 62 | Dermatology Consulting Services | High Point | North Carolina | United States | 27262 |
| 63 | Wilmington Dermatology Center | Wilmington | North Carolina | United States | 28405 |
| 64 | Synexus - Cincinnati | Cincinnati | Ohio | United States | 45249 |
| 65 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | 44106 |
| 66 | ClinOhio Research Services | Columbus | Ohio | United States | 43213 |
| 67 | Wright State Research Institute | Fairborn | Ohio | United States | 45324 |
| 68 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 69 | Unity Clinical Research | Oklahoma City | Oklahoma | United States | 73118 |
| 70 | Oregon Dermatology and Research Center | Portland | Oregon | United States | 97210 |
| 71 | Dermatology and Skin Surgery Center - Exton | Exton | Pennsylvania | United States | 19341 |
| 72 | Paddington Testing Company | Philadelphia | Pennsylvania | United States | 19103 |
| 73 | Synexus | Greer | South Carolina | United States | 29651 |
| 74 | Coastal Carolina Research Center - Mount Pleasant | Mount Pleasant | South Carolina | United States | 29464 |
| 75 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 76 | Rivergate Dermatology - Main Office | Goodlettsville | Tennessee | United States | 37072 |
| 77 | Clinical Research Solutions - Jackson | Jackson | Tennessee | United States | 38305 |
| 78 | Dermatology Associates of Knoxville | Knoxville | Tennessee | United States | 37917 |
| 79 | The Skin Wellness Center | Knoxville | Tennessee | United States | 37922 |
| 80 | Arlington Center for Dermatology | Arlington | Texas | United States | 76011 |
| 81 | DermResearch | Austin | Texas | United States | 78759 |
| 82 | Bellaire Dermatology | Bellaire | Texas | United States | 77401 |
| 83 | Modern Research Associates | Dallas | Texas | United States | 75231 |
| 84 | Synexus - Dallas | Dallas | Texas | United States | 75234 |
| 85 | Progressive Clinical Research - San Antonio | San Antonio | Texas | United States | 78213 |
| 86 | Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | United States | 78229 |
| 87 | Interspond - Houston Center for Clinical Research | Sugar Land | Texas | United States | 77479 |
| 88 | West Virginia University | Morgantown | West Virginia | United States | 26501 |
| 89 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 90 | Woden Dermatology | Phillip | Australian Capital Territory | Australia | 2606 |
| 91 | Holdsworth House Medical Practice | Darlinghurst | New South Wales | Australia | 2010 |
| 92 | St. George Dermatology & Skin Care Centre | Kogarah | New South Wales | Australia | 2217 |
| 93 | Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
| 94 | The Skin Centre | Benowa | Queensland | Australia | 4217 |
| 95 | Veracity Clinical Research | Woolloongabba | Queensland | Australia | 4102 |
| 96 | North Eastern Health Specialists | Hectorville | South Australia | Australia | 5073 |
| 97 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 98 | Skin and Cancer Foundation | Carlton | Victoria | Australia | 3053 |
| 99 | Sinclair Dermatology | East Melbourne | Victoria | Australia | 3002 |
| 100 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 101 | Fremantle Dermatology | Fremantle | Western Australia | Australia | 6160 |
| 102 | Institute for Skin Advancement | Calgary | Alberta | Canada | T3E 0B2 |
| 103 | Stratica Medical | Edmonton | Alberta | Canada | T5K 1X3 |
| 104 | University of British Columbia | Vancouver | British Columbia | Canada | V5Z 4E8 |
| 105 | CCA Medical Research | Ajax | Ontario | Canada | L1S 7K8 |
| 106 | Mediprobe Research | London | Ontario | Canada | N5X 2P1 |
| 107 | DermEffects | London | Ontario | Canada | N6H 5L5 |
| 108 | Lynderm Research | Markham | Ontario | Canada | L3P 1X2 |
| 109 | DermEdge | Mississauga | Ontario | Canada | L5H 1G9 |
| 110 | York Dermatology Clinic and Research Centre | Mississauga | Ontario | Canada | L5H 1G9 |
| 111 | Office of Dr. Niakosari Firouzeh | North York | Ontario | Canada | M2M 4J5 |
| 112 | Dermatology Ottawa Research Centre | Ottawa | Ontario | Canada | K2C 3N2 |
| 113 | Toronto Dermatology Centre | Toronto | Ontario | Canada | M3H 5Y8 |
| 114 | Dermatology on Bloor | Toronto | Ontario | Canada | M4W 2N4 |
| 115 | Kim Papp Clinical Research | Waterloo | Ontario | Canada | N2J 1C4 |
| 116 | Dr. Isabelle Delorme | Drummondville | Quebec | Canada | J2B 5L5 |
| 117 | Innovaderm Research | Montreal | Quebec | Canada | H2X 2V1 |
| 118 | Nemocnice Jihlava | Jihlava 1 | Czechia | 586 01 | |
| 119 | Nemocnice Novy Jicin a.s. | Novy Jicin | Czechia | 741 01 | |
| 120 | MUDr. Helena Korandova | Olomouc | Czechia | 779 00 | |
| 121 | Fakultni Nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
| 122 | Clintrial | Praha 10 | Czechia | 100 00 | |
| 123 | Sanatorium profesora Arenbergera | Praha 1 | Czechia | 110 00 | |
| 124 | Kozni a zilni ambulance | Usti nad Labem | Czechia | 400 10 | |
| 125 | Krajska zdravotni - Masarykova nemocnice v Usti nad Labem | Usti nad Labem | Czechia | 401 13 | |
| 126 | Terveystalo Tampere | Tampere | Finland | 33100 | |
| 127 | Mehilainen Turku | Turku | Finland | 20100 | |
| 128 | Vaasan Keskussairaala | Vaasa | Finland | 65100 | |
| 129 | Hopital Prive dAntony | Antony | France | 92160 | |
| 130 | Centre Hospitalier Regional Universitaire Brest Hopital Morvan | Brest Cedex | France | 29609 | |
| 131 | Centre Hospitalier Universitaire de Nice Hopital lArchet | Nice Cedex 3 | France | 06202 | |
| 132 | Centre Hospitalier Universitaire de Toulouse- Hopital Larrey | Toulouse Cedex 9 | France | 31059 | |
| 133 | Licca Clinical Research Institute | Augsburg | Germany | 86179 | |
| 134 | Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus | Bochum | Germany | 44793 | |
| 135 | Hautarztpraxis Dr. Beatrice Gerlach | Dresden | Germany | 01097 | |
| 136 | Synexus Frankfurt Clinical Research | Frankfurt am Main | Germany | 60313 | |
| 137 | Klinische Forschung Hamburg GmbH | Hamburg | Germany | 20253 | |
| 138 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 139 | Dermakiel - Allergie Und Haut Centrum | Kiel | Germany | 24148 | |
| 140 | Praxis Dr. Beate Schwarz | Langenau | Germany | 89129 | |
| 141 | Universitatsklinikum Schleswig-Holstein - Campus Lubeck | Lubeck | Germany | 23538 | |
| 142 | Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog | Munchen | Germany | 80802 | |
| 143 | Harzklinikum Dorothea Christiane Erxleben | Quedlinburg | Germany | 06484 | |
| 144 | Praxis Dr. med. Wilfried Steinborn | Straubing | Germany | 94315 | |
| 145 | CentroDerm GmbH | Wuppertal | Germany | 42287 | |
| 146 | Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft. | Budapest | Hungary | 1036 | |
| 147 | Synexus Magyarorszag | Budapest | Hungary | 1036 | |
| 148 | Semmelweis Egyetem | Budapest | Hungary | 1085 | |
| 149 | Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site | Debrecen | Hungary | 4025 | |
| 150 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
| 151 | Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula | Gyula | Hungary | 5700 | |
| 152 | Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat | Nyiregyhaza | Hungary | 4400 | |
| 153 | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs | Hungary | 7632 | |
| 154 | Szegedi Tudomanyegyetem | Szeged | Hungary | 6720 | |
| 155 | Allergo-Derm Bakos | Szolnok | Hungary | 5000 | |
| 156 | Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg | Zalaegerszeg | Hungary | 8900 | |
| 157 | Local Institution | Haifa | Israel | 3436212 | |
| 158 | Local Institution | Kfar Saba | Israel | 4428164 | |
| 159 | Local Institution | Petah Tikva | Israel | 49100 | |
| 160 | Local Institution | Ramat Gan | Israel | 52621 | |
| 161 | Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi | Bologna | Italy | 40138 | |
| 162 | Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara | Pisa | Italy | 56126 | |
| 163 | Local Institution | Hamilton | New Zealand | 3206 | |
| 164 | Local Institution | Mount Cook | New Zealand | 6021 | |
| 165 | Local Institution | Tauranga | New Zealand | 3110 | |
| 166 | ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik | Bialystok | Poland | 15-351 | |
| 167 | ClinicMed Daniluk Nowak Spolka Jawna | Bialystok | Poland | 15-879 | |
| 168 | Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska | Elblag | Poland | 82-300 | |
| 169 | Synexus Polska Oddzial w Gdansk | Gda?sk | Poland | 80-382 | |
| 170 | Zespol Naukowo-Leczniczy Iwolang | Iwonicz-Zdroj | Poland | 38-440 | |
| 171 | Krakowskie Centrum Medyczne | Krakow | Poland | 31-501 | |
| 172 | Dermed Centrum Medyczne | Lodz | Poland | 90-265 | |
| 173 | Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak | Lodz | Poland | 90-436 | |
| 174 | Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER | Lublin | Poland | 20-406 | |
| 175 | ETG - Siedlce | Siedlce | Poland | 08-110 | |
| 176 | ETG - Skierniewice | Skierniewice | Poland | 96-100 | |
| 177 | Nasz Lekarz Przychodnie Medyczne | Torun | Poland | 87-100 | |
| 178 | Klinika Ambroziak | Warsaw | Poland | 02-953 | |
| 179 | High-Med Przychodnia Specjalistyczna | Warszawa | Poland | 01-817 | |
| 180 | Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warszawa | Poland | 02-008 | |
| 181 | ETG - Warszawa | Warszawa | Poland | 02-793 | |
| 182 | Centrum Medyczne Oporow | Wroclaw | Poland | 52-416 | |
| 183 | GCM Medical Group | San Juan | Puerto Rico | 917 | |
| 184 | Hospital Universitario Reina Sofia | Cordoba | Spain | 14004 | |
| 185 | Hospital Universitario de Vinalopo | Elche | Spain | 03293 | |
| 186 | Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas de Gran Canaria | Spain | 35010 | |
| 187 | Hospital Universitario Ramon Y Cajal | Madrid | Spain | 28034 | |
| 188 | Hospital de Manises | Manises | Spain | 46940 | |
| 189 | Hospital Universitario Virgen de la Victoria | Mߧa | Spain | 29010 | |
| 190 | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcon | Spain | 28223 | |
| 191 | Burbage Surgery | Santiago de Compostela | Spain | 15706 | |
| 192 | Consorci Hospital General Universitari de Valencia | Valencia | Spain | 46014 | |
| 193 | Ladulaas Kliniska Studier | Boras | Sweden | 506 30 | |
| 194 | Pharmasite - Helsingborg | Helsingborg | Sweden | 25200 | |
| 195 | ProbarE i Lund | Lund | Sweden | 22222 | |
| 196 | PharmaSite - Malmo | Malmo | Sweden | 211 52 | |
| 197 | Karolinska Universitetssjukhuset | Solna | Sweden | 171 76 | |
| 198 | MAC Clinical Research - Cannock | Cannock | United Kingdom | WS11 0BN | |
| 199 | Ashgate Medical Practice | Chesterfield | United Kingdom | S40 4AA | |
| 200 | Synexus - Lancashire Clinical Research Centre | Chorley | United Kingdom | PR7 7NA | |
| 201 | Mounts Bay Medical | Cornwall | United Kingdom | TR27 5DT | |
| 202 | The Dudley Group NHS Foundation Trust | Dudley | United Kingdom | DY1 2HQ | |
| 203 | MAC Clinical Research - Stockton | Durham | United Kingdom | TS17 6EW | |
| 204 | The Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | LS7 4SA | |
| 205 | MAC Clinical Research - Manchester | Manchester | United Kingdom | M13 9NQ |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03611751
Other Study ID Numbers:
- IM011-047
- 2018-001925-24
First Posted:
Aug 2, 2018
Last Update Posted:
Dec 3, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: