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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03611751




Registration number
NCT03611751
Ethics application status
Date submitted
25/07/2018
Date registered
2/08/2018
Date last updated
28/08/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2018-001925-24
Secondary ID [2] 0 0
IM011-047
Universal Trial Number (UTN)
Trial acronym
POETYK-PSO-2
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
Other interventions - Placebo
Treatment: Drugs - Apremilast

Experimental: BMS-986165 - BMS-986165 oral administration

Placebo Comparator: Placebo - Placebo oral administration

Active Comparator: Active comparator - Active comparator oral administration


Treatment: Drugs: BMS-986165
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days

Treatment: Drugs: Apremilast
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Static Physician's Global Assessment (sPGA) score of 0 or 1
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
PASI 75 (75% reduction in Psoriasis Area and Severity Index)
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
PASI 90
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
PASI 100
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Psoriasis Symptoms and Signs Diary (PSSD) score
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Dermatology Life Quality Index (DLQI) score
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Physician Global Assessment- Fingernails (PGA-F) score 0 or 1
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Maintenance of PASI 75
Timepoint [8] 0 0
Week 52

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Plaque psoriasis for at least 6 months

- Moderate to severe disease

- Candidate for phototherapy or systemic therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
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
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United States of America
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Alabama
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Kentucky
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Massachusetts
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Michigan
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Missouri
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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 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 website
https://clinicaltrials.gov/show/NCT03611751
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
Other publications