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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02931838




Registration number
NCT02931838
Ethics application status
Date submitted
3/10/2016
Date registered
13/10/2016
Date last updated
27/11/2020

Titles & IDs
Public title
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis
Secondary ID [1] 0 0
IM011-011
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
Experimental: BMS-986165 Dose 1 - Specified dose of BMS-986165 on specified days.

Experimental: BMS-986165 Dose 2 - Specified dose of BMS-986165 on specified days.

Experimental: BMS-986165 Dose 3 - Specified dose of BMS-986165 on specified days.

Experimental: BMS-986165 Dose 4 - Specified dose of BMS-986165 on specified days.

Experimental: BMS-986165 Dose 5 - Specified dose of BMS-986165 on specified days.

Placebo comparator: Placebo - Specified dose of Placebo for BMS-986165 on specified days.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Timepoint [1] 0 0
Day 1 to Day 85
Primary outcome [2] 0 0
Number of Participants With Adverse Events
Timepoint [2] 0 0
Day 1 to day 115
Secondary outcome [1] 0 0
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Timepoint [1] 0 0
Day 1 to Day 85
Secondary outcome [2] 0 0
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Timepoint [2] 0 0
Day 1 to Day 85
Secondary outcome [3] 0 0
Change From Baseline in DLQI Scores on Day 85
Timepoint [3] 0 0
Day 1 to Day 85
Secondary outcome [4] 0 0
Change From Baseline in BSA on Day 85
Timepoint [4] 0 0
Day 1 to Day 85
Secondary outcome [5] 0 0
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Timepoint [5] 0 0
Days 8, 15, 29, 57, 85

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



* Male and female, ages 18 to 70 years
* Diagnosis of plaque psoriasis for 6 months
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any significant acute or chronic medical illness
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication
* Positive hepatitis-B (HBV) surface antigen
* Positive hepatitis-C (HCV) antibody
* Any history or risk for tuberculosis (TB)
* Any major illness/condition or evidence of an unstable clinical condition
* Chest X-ray findings suspicious of infection at screening
* has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
* Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
* Has received Rituximab within 6 months of first administration of study medication
* Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
* Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
15/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2017
Sample size
Target
Accrual to date
Final
268
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Wolloongabba
Recruitment hospital [3] 0 0
Local Institution - Melbourne
Recruitment hospital [4] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Wolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
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New Hampshire
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United States of America
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North Carolina
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United States of America
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Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
South Dakota
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
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Canada
State/province [14] 0 0
Ontario
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Canada
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Quebec
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Germany
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Dresden
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Germany
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Gera
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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Mahlow
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Germany
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Mainz
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Germany
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Schwerin
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Germany
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Stuttgart
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kyoto
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Kumamoto
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Japan
State/province [33] 0 0
Osaka
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Latvia
State/province [34] 0 0
Daugavpils
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Latvia
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Riga
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Latvia
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Ventspils
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Mexico
State/province [37] 0 0
Jalisco
Country [38] 0 0
Mexico
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Nuevo LEON
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Osielsko
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Siedlce
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Skierniewice
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Warszawa
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Poland
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Wroc?aw
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Poland
State/province [47] 0 0
Wroclaw

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/NCT02931838