We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04036435




Registration number
NCT04036435
Ethics application status
Date submitted
25/07/2019
Date registered
29/07/2019
Date last updated
19/10/2020

Titles & IDs
Public title
Long-Term Study That Measures the Safety and Efficacy of BMS-986165 in Participants With Psoriasis.
Scientific title
An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis.
Secondary ID [1] 0 0
2019-000612-29
Secondary ID [2] 0 0
IM011-075
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165

Experimental: BMS-986165 -


Treatment: Drugs: BMS-986165
Participants will receive BMS-986165 in tablet form

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
static Physician Global Assessment (sPGA)0/1 response
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
Psoriasis Area and Severity Index (PASI) 75 response
Timepoint [2] 0 0
96 weeks

Eligibility
Key inclusion criteria
- Completion of the protocol-required treatment period in an applicable study of
BMS-986165 in moderate-to-severe psoriasis

- Women must not be pregnant, lactating, or breastfeeding
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any disease or medical condition that the investigator feels that would make the
patient unsuitable for this study.

- To be eligible for the study, a participant must not have active signs or symptoms of
tuberculosis (TB) as judged by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
St. George Dermatology & Skin Care Centre - Kogarah
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
The Skin Centre - Benowa
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Skin and Cancer Foundation - Carlton
Recruitment hospital [10] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [11] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [12] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5073 - Hectorville
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3053 - Carlton
Recruitment postcode(s) [10] 0 0
3002 - East Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Manitoba
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
China
State/province [35] 0 0
Beijing
Country [36] 0 0
China
State/province [36] 0 0
Chongqing
Country [37] 0 0
China
State/province [37] 0 0
Jiangsu
Country [38] 0 0
China
State/province [38] 0 0
Liaoning
Country [39] 0 0
China
State/province [39] 0 0
Shan1xi
Country [40] 0 0
China
State/province [40] 0 0
Shanghai
Country [41] 0 0
China
State/province [41] 0 0
Zhejiang
Country [42] 0 0
Czechia
State/province [42] 0 0
Jihlava 1
Country [43] 0 0
Czechia
State/province [43] 0 0
Novy Jicin
Country [44] 0 0
Czechia
State/province [44] 0 0
Olomouc
Country [45] 0 0
Czechia
State/province [45] 0 0
Ostrava
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 10
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 1
Country [48] 0 0
Czechia
State/province [48] 0 0
Usti nad Labem
Country [49] 0 0
Finland
State/province [49] 0 0
Tampere
Country [50] 0 0
Finland
State/province [50] 0 0
Turku
Country [51] 0 0
France
State/province [51] 0 0
Antony
Country [52] 0 0
France
State/province [52] 0 0
Nice Cedex 3
Country [53] 0 0
Germany
State/province [53] 0 0
Augsburg
Country [54] 0 0
Germany
State/province [54] 0 0
Bochum
Country [55] 0 0
Germany
State/province [55] 0 0
Dresden
Country [56] 0 0
Germany
State/province [56] 0 0
Frankfurt am Main
Country [57] 0 0
Germany
State/province [57] 0 0
Hamburg
Country [58] 0 0
Germany
State/province [58] 0 0
Hannover
Country [59] 0 0
Germany
State/province [59] 0 0
Kiel
Country [60] 0 0
Germany
State/province [60] 0 0
Langenau
Country [61] 0 0
Germany
State/province [61] 0 0
Munchen
Country [62] 0 0
Germany
State/province [62] 0 0
Straubing
Country [63] 0 0
Germany
State/province [63] 0 0
Wuppertal
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Hungary
State/province [65] 0 0
Debrecen
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyula
Country [67] 0 0
Hungary
State/province [67] 0 0
Nyiregyhaza
Country [68] 0 0
Hungary
State/province [68] 0 0
Pecs
Country [69] 0 0
Hungary
State/province [69] 0 0
Szeged
Country [70] 0 0
Hungary
State/province [70] 0 0
Szolnok
Country [71] 0 0
Hungary
State/province [71] 0 0
Zalaegerszeg
Country [72] 0 0
Israel
State/province [72] 0 0
Haifa
Country [73] 0 0
Israel
State/province [73] 0 0
Petah Tikva
Country [74] 0 0
Israel
State/province [74] 0 0
Ramat Gan
Country [75] 0 0
Japan
State/province [75] 0 0
Aichi
Country [76] 0 0
Japan
State/province [76] 0 0
Fukuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Hokkaido
Country [78] 0 0
Japan
State/province [78] 0 0
Hyogo
Country [79] 0 0
Japan
State/province [79] 0 0
Kanagawa
Country [80] 0 0
Japan
State/province [80] 0 0
Kochi
Country [81] 0 0
Japan
State/province [81] 0 0
Kyoto
Country [82] 0 0
Japan
State/province [82] 0 0
MIE
Country [83] 0 0
Japan
State/province [83] 0 0
Nagano
Country [84] 0 0
Japan
State/province [84] 0 0
Okayama
Country [85] 0 0
Japan
State/province [85] 0 0
Shizuoka
Country [86] 0 0
Japan
State/province [86] 0 0
Tochigi
Country [87] 0 0
Japan
State/province [87] 0 0
Tokyo
Country [88] 0 0
Japan
State/province [88] 0 0
Kumamoto
Country [89] 0 0
Japan
State/province [89] 0 0
Osaka
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Bucheon-si
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Busan
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Goyang-si
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Gwangju
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Hwaseong-si
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Incheon
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Seongnam-si
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Suwon
Country [99] 0 0
New Zealand
State/province [99] 0 0
Mount Cook
Country [100] 0 0
New Zealand
State/province [100] 0 0
Tauranga
Country [101] 0 0
Poland
State/province [101] 0 0
Bialystok
Country [102] 0 0
Poland
State/province [102] 0 0
Elblag
Country [103] 0 0
Poland
State/province [103] 0 0
Gda?sk
Country [104] 0 0
Poland
State/province [104] 0 0
Gdynia
Country [105] 0 0
Poland
State/province [105] 0 0
Iwonicz-Zdroj
Country [106] 0 0
Poland
State/province [106] 0 0
Katowice
Country [107] 0 0
Poland
State/province [107] 0 0
Krakow
Country [108] 0 0
Poland
State/province [108] 0 0
Krak
Country [109] 0 0
Poland
State/province [109] 0 0
Lodz
Country [110] 0 0
Poland
State/province [110] 0 0
Lublin
Country [111] 0 0
Poland
State/province [111] 0 0
Olsztyn
Country [112] 0 0
Poland
State/province [112] 0 0
Osielsko
Country [113] 0 0
Poland
State/province [113] 0 0
Poznan
Country [114] 0 0
Poland
State/province [114] 0 0
Siedlce
Country [115] 0 0
Poland
State/province [115] 0 0
Skierniewice
Country [116] 0 0
Poland
State/province [116] 0 0
Torun
Country [117] 0 0
Poland
State/province [117] 0 0
Warsaw
Country [118] 0 0
Poland
State/province [118] 0 0
Warszawa
Country [119] 0 0
Poland
State/province [119] 0 0
Wroc?aw
Country [120] 0 0
Poland
State/province [120] 0 0
Wroclaw
Country [121] 0 0
Puerto Rico
State/province [121] 0 0
San Juan
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Ekaterinburg
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Kazan
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Krasnodar
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Moscow
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Ryazan
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Saint Petersburg
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Saratov
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Smolensk
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Yaroslavl
Country [131] 0 0
Spain
State/province [131] 0 0
Alcorcon
Country [132] 0 0
Spain
State/province [132] 0 0
Badalona
Country [133] 0 0
Spain
State/province [133] 0 0
Barakaldo
Country [134] 0 0
Spain
State/province [134] 0 0
Cordoba
Country [135] 0 0
Spain
State/province [135] 0 0
Las Palmas De Gran Canaria
Country [136] 0 0
Spain
State/province [136] 0 0
M?a
Country [137] 0 0
Spain
State/province [137] 0 0
Madrid
Country [138] 0 0
Spain
State/province [138] 0 0
Manises
Country [139] 0 0
Spain
State/province [139] 0 0
Pozuelo de Alarcon
Country [140] 0 0
Spain
State/province [140] 0 0
Valencia
Country [141] 0 0
Sweden
State/province [141] 0 0
Boras
Country [142] 0 0
Sweden
State/province [142] 0 0
Lund
Country [143] 0 0
Sweden
State/province [143] 0 0
Solna
Country [144] 0 0
Taiwan
State/province [144] 0 0
Kaohsiung
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taipei City
Country [146] 0 0
Taiwan
State/province [146] 0 0
Taipei
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cannock
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Chesterfield
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Chorley
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Cornwall
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Dudley
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Durham
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Lancashire
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Leicestershire
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Liverpool
Country [156] 0 0
United Kingdom
State/province [156] 0 0
London
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Manchester
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Prescot

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to characterize the long-term safety and efficacy of the
drug BMS-986165 in patients who have been previously enrolled in an applicable Phase 3
psoriasis study.
Trial website
https://clinicaltrials.gov/show/NCT04036435
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rachel Peterson
Address 0 0
Country 0 0
Phone 0 0
+1 619 293 6213
Fax 0 0
Email 0 0
PetersonRachel@prahs.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04036435