Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03624127
Collaborator
(none)
666
Enrollment
164
Locations
3
Arms
24.9
Actual Duration (Months)
4.1
Patients Per Site
0.2
Patients Per Site Per Month

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 :
666 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 :
Aug 7, 2018
Actual Primary Completion Date :
Sep 2, 2020
Actual Study Completion Date :
Sep 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986165

Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo

Other: Placebo
Specified dose on specified days
Active Comparator: Apremilast

Drug: Apremilast
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieve static Physician Global Assessment (sPGA) score of 0 or 1 response [At Week 16]

    sPGA 0/1 response assessed as a proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least 2-point improvement from baseline

  2. Proportion of participants achieve 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) score [At Week 16]

Secondary Outcome Measures

  1. Proportion of participants achieve 90% improvement from baseline in the PASI score [At Week 16]

    PASI 75 response assessed as a proportion of subjects who achieve a 90% improvement from baseline in the PASI score

  2. Proportion of participants achieve 100% improvement from baseline in the PASI score [At Week 16]

  3. Proportion of participants achieve sPGA score of 0 [At week 16]

  4. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score [Baseline to Week 16]

  5. Proportion of participants achieve PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1 [Baseline to Week 16]

    scores range from 0-100, where 0 representing the least severe symptom and 100 the most severe symptom

  6. Proportion of participants achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score ≥3 [Baseline to Week 16]

  7. Proportion of participants achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 among participants with a baseline DLQI score ≥2 [Baseline to Week 16]

  8. Proportion of participants achieve Physician Global Assessment- Fingernails (PGA-F) score of 0 or 1 among participants with a baseline PGA-F score ≥3 [Baseline to Week 16]

  9. Proportion of participants achieve palmoplantar Physician's Global Assessment (pp-PGA) score of 0 or 1 among participants with a baseline pp-PGA score ≥3 [Baseline to Week 16]

  10. Proportion of participants achieve 75% improvement in PASI score [Baseline to Week 52]

  11. Proportion of participants achieve 90% improvement from baseline in the PASI score [Baseline to Week 52]

  12. Proportion of participants achieve sPGA score of 0 or 1 [Baseline to 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 apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Achieve Clinical Research Birmingham Alabama United States 35216
2 Coastal Clinical Research - Mobile Mobile Alabama United States 36608
3 Elite Clinical Studies Phoenix Arizona United States 85018
4 Arizona Research Center Phoenix Arizona United States 85053
5 Synexus - Tucson Tucson Arizona United States 85741
6 Hull Dermatology Rogers Arkansas United States 72758
7 First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley Fountain Valley California United States 92708
8 University California at Irvine Dermatology Clinical Research Center Irvine California United States 92697
9 Keck School of Medicine Los Angeles California United States 90033
10 Dream Team Clinical Research Pomona California United States 91767
11 University Dermatology Group San Diego California United States 92123
12 Unison Clinical Trials Sherman Oaks California United States 91403
13 New England Research Associates Bridgeport Connecticut United States 06606
14 Precision Clinical Research Davie Florida United States 33328
15 Indago Research and Health Center Hialeah Florida United States 33012
16 San Marcus Research Clinic Miami Lakes Florida United States 33014
17 LCC Medical Research Miami Florida United States 33126
18 International Dermatology Research Miami Florida United States 33144
19 Well Pharma Medical Research Miami Florida United States 33173
20 Miami Dade Medical Research Institute Miami Florida United States 33176
21 Renstar Medical Research Ocala Florida United States 34471
22 Ameriderm Research Ormond Beach Florida United States 32174
23 Olympian Clinical Research - South Tampa Office Tampa Florida United States 33614-7118
24 Palm Beach Research Center West Palm Beach Florida United States 33409-3401
25 Hamilton Dermatology Alpharetta Georgia United States 30022
26 Healthcare Research Network - Flossmoor Flossmoor Illinois United States 60402
27 Springfield Clinic Springfield Illinois United States 62703
28 Deaconess Clinic Downtown Evansville Indiana United States 47708
29 The Dermatology Center New Albany Indiana United States 47150
30 The Indiana Clinical Trials Center Plainfield Indiana United States 46168
31 The South Bend Clinic South Bend Indiana United States 46617
32 Kansas City Dermatology Overland Park Kansas United States 66215
33 Dermatology Specialists Research-Kentucky Louisville Kentucky United States 40241
34 Clinical Trials of America - Monroe Monroe Louisiana United States 71201
35 Etre Cosmetic Dermatology and Laser Center New Orleans Louisiana United States 70130
36 ActivMed Practices and Research - Beverly Beverly Massachusetts United States 01915
37 DermCare Experts Quincy Massachusetts United States 02169
38 David Fivenson MD Dermatology Ann Arbor Michigan United States 48103
39 Somerset Skin Centre Troy Michigan United States 48084
40 Associated Skin Care Specialists - Minnesota Clinical Study Center New Brighton Minnesota United States 55112
41 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
42 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
43 Hassman Research Institute Berlin New Jersey United States 08009
44 Forest Hills Dermatology Group Kew Gardens New York United States 11374
45 Mount Sinai - Queens New York New York United States 10023
46 PMG Research of Charlotte Charlotte North Carolina United States 28209
47 Duke University Health System - Duke Clinic Durham North Carolina United States 27710-4000
48 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
49 The Ohio State University Wexner Medical Center Columbus Ohio United States 43203
50 Synexus - Columbus Columbus Ohio United States 43212
51 Health Research of Oklahoma Oklahoma City Oklahoma United States 73103-2433
52 Oregon Medical Research Center Portland Oregon United States 97223
53 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
54 Clinical Research Center of Reading Wyomissing Pennsylvania United States 19610
55 Synexus Clinical Research - Anderson Anderson South Carolina United States 29621
56 Clinical Research Center of the Carolinas Charleston South Carolina United States 29407
57 Interspond - Stones River Dermatology - Murfreesboro Office Murfreesboro Tennessee United States 37129
58 Westlake Dermatology - Westlake Austin Texas United States 78746
59 Dermatology Treatment and Research Center Dallas Texas United States 75230
60 Metroplex Clinical Research Center Dallas Texas United States 75231
61 Menter Dermatology Research Institute Dallas Texas United States 75246
62 Austin Institute for Clinical Research - Pflugerville Pflugerville Texas United States 78660
63 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78218
64 Interspond - Acclaim Dermatology Sugar Land Texas United States 77479
65 Center for Clinical Studies - Webster Webster Texas United States 77598
66 Dermatology Associates of Seattle Seattle Washington United States 98101
67 Eastern Washington Dermatology Walla Walla Washington United States 99362
68 Kirk Barber Research Calgary Alberta Canada T2G 1B1
69 Dr. Chih-ho Hong Medical Inc. Surrey British Columbia Canada V3R 6A7
70 Wiseman Dermatology Research Winnipeg Manitoba Canada R3M 3Z4
71 The Guenther Dermatology Research Centre London Ontario Canada N6A 3H7
72 Office of Dr. Arnon Moshe Katz Newmarket Ontario Canada L3Y 6P5
73 North Bay Dermatology Centre North Bay Ontario Canada P1B 3Z7
74 Institute of Cosmetic and Laser Surgery Oakville Ontario Canada L6J 7W5
75 Skin Centre for Dermatology Peterborough Ontario Canada K9J 5K2
76 The Centre for Dermatology - Richmond Hill Richmond Hill Ontario Canada L4B 1A5
77 XLR8 Medical Research Windsor Ontario Canada N8W 1E6
78 Docteur David Gratton Dermatologue Montreal Quebec Canada H3H 1V4
79 Siena Medical Research Montreal Quebec Canada H3Z 2S6
80 Centre de Recherche Dermatologique du Quebec Metropolitain Quebec Canada G1V 4X7
81 Local Institution Beijing Beijing China 100050
82 Local Institution Wuhan Hubei China 430030
83 Local Institution Hangzhou Zhejiang China 310009
84 Charite Universitatsmedizin Berlin Berlin Germany 10117
85 Klinische Forschung Dresden GmbH Dresden Germany 01069
86 Nagoya City University Hospital Nagoya Aichi Japan 467-8602
87 Ehime University Hospital Toon-Shi Ehime Japan 791-0295
88 Fukuoka University Hospital Fukuoka-shi Fukuoka Japan 814-0180
89 University of Occupational and Environmental Health, Japan Kitakyushu Fukuoka Japan 807-8555
90 Sapporo Skin Clinic Sapporo Hokkaido Japan 060-0063
91 Kobe University Hospital Kobe Hyogo Japan 650-0017
92 Tokai University Hospital Isehara City Kanagawa Japan 259-1193
93 National Hospital Organization Yokohama Medical Center Yokohama-shi Kanagawa Japan 2458575
94 Yokohama City University Hospital Yokohama Kanagawa Japan 236-0004
95 Kochi Medical School Hospital Nakoku Kochi Japan 783-8505
96 University Hospital - Kyoto Preferctural University of Medicine Kyoto-city Kyoto Japan 602-8566
97 Mie University Hospital Tsu MIE Japan 514-8507
98 Shinshu University Hospital Matsumoto Nagano Japan 3908621
99 Kurashiki Central Hospital Kurashiki Okayama Japan 7108602
100 Osaka City University Hospital Osaka-shi Osaka Japan 5458586
101 Hamamatsu University Hospital Hamamatsu Shizuoka Japan 431-3192
102 Jichi Medical University Hospital Shimotsuke Tochigi Japan 329-0498
103 Teikyo University Hospital Itabashi-Ku Tokyo Japan 173-8606
104 Nihon University Itabashi Hospital Itabashi-ku Tokyo Japan 173-8610
105 The Jikei University Hospital Minato-ku Tokyo Japan 105-8471
106 NTT Medical Center Tokyo Shinagawa Tokyo Japan 141-8625
107 Tokyo Medical University Hospital Shinjuku-Ku Tokyo Japan 169-0073
108 Japan Community Health Care Organization Tokyo Yamate Medical Center Shinjuku Tokyo Japan 169-0073
109 Kumamoto University Hospital Kumamoto Japan 860-8556
110 Kyoto University Hospital Kyoto Japan 606-8507
111 Nippon Life Hospital Osaka Japan 550-0006
112 Local Institution Busan Korea, Republic of 49241
113 Local Institution Hwaseong-si Korea, Republic of 18450
114 Local Institution Incheon Korea, Republic of 21565
115 Local Institution Seongnam-si Korea, Republic of 13620
116 Local Institution Seoul Korea, Republic of 120-752
117 Local Institution Seoul Korea, Republic of 137-701
118 Local Institution Seoul Korea, Republic of 660-702
119 Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk Bialystok Poland 15-099
120 Synexus Polska Oddzial w Gdyni Gdynia Poland 81-537
121 Synexus - Katowice Katowice Poland 40-040
122 Pratia MCM Krakow Krak Poland 30-510
123 Centrum Terapii Wspolczesnej Lodz Poland 90-242
124 Centrum Medyczne All-Med Lodz Poland 94-048
125 Miejski Szpital Zespolony w Olsztynie Olsztyn Poland 10-229
126 DermoDent - Centrum Medyczne Czajkowscy Osielsko Poland 86-031
127 Solumed Centrum Medyczne Poznan Poland 60-529
128 Centrum Badan Klinicznych S.C. Poznan Poland 60-773
129 Clinical Research Group Warszawa Poland 01-142
130 Royalderm Agnieszka Nawrocka Warszawa Poland 02-962
131 Center for Clinical Studies - Texas Medical Center Wroclaw Poland 50-367
132 Lukasz Matusiak 4health Wroclaw Poland 50-566
133 dermMedica Sp. z o.o. Wroclaw Poland 51-318
134 WroMedica Wroclaw Poland 51-685
135 Ural Scientific Research Institute of Dermatovenereology and Immunopathology Ekaterinburg Russian Federation
136 Azbuka Zdorovya Medical Center Kazan Russian Federation 42011
137 SBHI Clinical Skin and Venereology Dispensary of the Ministry of Health of Krasnodar Region Krasnodar Russian Federation 350020
138 NIARMEDIK - Clinic on Clinic on Kitai Gorod Moscow Russian Federation 101000
139 Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov Moscow Russian Federation 111398
140 State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary Ryazan Russian Federation 390046
141 Polyclinic of Private Security Personnel Saint Petersburg Russian Federation 192007
142 Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology Saint Petersburg Russian Federation 194021
143 Ars Vitae Multidisciplinary Medical Center Saint Petersburg Russian Federation 194223
144 Clinic of Skin Diseases of Pierre Wolkenstein Saint Petersburg Russian Federation
145 Klinika Kozhnykh I Venericheskikh Bolezney Saratov Russian Federation 410028
146 Smolensk State Medical University Smolensk Russian Federation 214019
147 MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev Yaroslavl Russian Federation 150003
148 Hospital Universitario Fundacion Alcorcon Alcorcon Spain 28922
149 Hospital Universitari Germans Trias i Pujol Badalona Spain 08916
150 Hospital Universitario Cruces Barakaldo Spain 48903
151 Hospital del Mar - Parc de Salut Mar Barcelona Spain 08003
152 Hospital Universitario La Paz Madrid Spain 28046
153 Hospital Universitario de Fuenlabrada Madrid Spain 28942
154 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026
155 Local Institution Kaohsiung Taiwan 81362
156 Local Institution Taipei Taiwan 10099
157 Local Institution Taipei Taiwan 11217
158 MAC Clinical Research - Blackpool Lancashire United Kingdom FY2 0JH
159 Synexus - Merseyside Clinical Research Centre Liverpool United Kingdom L22 0LG
160 Guys and Saint Thomas NHS Foundation Trust London United Kingdom SE1 9RT
161 Synexus - Manchester Clinical Research Centre Manchester United Kingdom M15 6SE
162 Salford Royal NHS Foundation Trust Manchester United Kingdom M6 8HD
163 Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne United Kingdom NE1 4LP
164 MAC Clinical Research - Liverpool Prescot United Kingdom L34 1BH

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:
NCT03624127
Other Study ID Numbers:
  • IM011-046
  • 2018-001926-25
First Posted:
Aug 9, 2018
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis
Apremilast
BMS-986165

Study Results

No Results Posted as of Sep 5, 2021