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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04036435




Registration number
NCT04036435
Ethics application status
Date submitted
25/07/2019
Date registered
29/07/2019
Date last updated
28/09/2023

Titles & IDs
Public title
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (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
POETYK PSO-LTE
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
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 244 weeks
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 244 weeks
Secondary outcome [1] 0 0
static Physician Global Assessment (sPGA) 0/1 response
Timepoint [1] 0 0
Up to 240 weeks
Secondary outcome [2] 0 0
Psoriasis Area and Severity Index (PASI) 75 response
Timepoint [2] 0 0
Up to 240 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
18 Years
Maximum age
No limit
Sex
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.

Other protocol-defined inclusion/exclusion criteria apply

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/07/2026
Actual
Sample size
Target
Accrual to date
Final
1452
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
Local Institution - 0250 - 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
Local Institution - 0245 - 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
Local Institution - 0251 - Parkville
Recruitment hospital [12] 0 0
Local Institution - 0247 - Perth
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
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4217 - Benowa
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
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5073 - Hectorville
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
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3053 - Carlton
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3002 - East Melbourne
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3050 - Parkville
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6160 - Perth
Recruitment outside Australia
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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 Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an
applicable Phase 3 psoriasis study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04036435
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04036435