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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03611751
Ethics application status
Date submitted
25/07/2018
Date registered
2/08/2018
Date last updated
20/12/2022

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
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
Timepoint [12] 0 0
From Week 24 to Week 52 (up to approximately 28 weeks)
Secondary outcome [13] 0 0
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
Timepoint [15] 0 0
Baseline and week 24

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2020
Sample size
Target
Accrual to date
Final
1020
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
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Illinois
Country [10] 0 0
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Indiana
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Kentucky
Country [12] 0 0
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Louisiana
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Massachusetts
Country [14] 0 0
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Michigan
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Missouri
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Nevada
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New Hampshire
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Jihlava 1
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Praha 10
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03611751