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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - BMS-986165
Treatment: Drugs - Placebo for BMS-986165

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.


Treatment: Drugs: BMS-986165


Treatment: Drugs: Placebo for BMS-986165


Intervention code [1] 0 0
Treatment: Drugs
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) - Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved = 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Timepoint [1] 0 0
Day 1 to Day 85
Primary outcome [2] 0 0
Number of Participants With Adverse Events - The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
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. - Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved = 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved = 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved = 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
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). - Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Timepoint [2] 0 0
Day 1 to Day 85
Secondary outcome [3] 0 0
Change From Baseline in DLQI Scores on Day 85 - The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
Timepoint [3] 0 0
Day 1 to Day 85
Secondary outcome [4] 0 0
Change From Baseline in BSA on Day 85 - Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
Timepoint [4] 0 0
Day 1 to Day 85
Secondary outcome [5] 0 0
Trough Observed Plasma Concentration of BMS-986165 (Ctrough) - Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
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
Gender
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
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)
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
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
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
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Gera
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
Germany
State/province [20] 0 0
Luebeck
Country [21] 0 0
Germany
State/province [21] 0 0
Mahlow
Country [22] 0 0
Germany
State/province [22] 0 0
Mainz
Country [23] 0 0
Germany
State/province [23] 0 0
Schwerin
Country [24] 0 0
Germany
State/province [24] 0 0
Stuttgart
Country [25] 0 0
Japan
State/province [25] 0 0
Aichi
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Hyogo
Country [29] 0 0
Japan
State/province [29] 0 0
Kyoto
Country [30] 0 0
Japan
State/province [30] 0 0
Tochigi
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Japan
State/province [32] 0 0
Kumamoto
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Latvia
State/province [34] 0 0
Daugavpils
Country [35] 0 0
Latvia
State/province [35] 0 0
Riga
Country [36] 0 0
Latvia
State/province [36] 0 0
Ventspils
Country [37] 0 0
Mexico
State/province [37] 0 0
Jalisco
Country [38] 0 0
Mexico
State/province [38] 0 0
Nuevo LEON
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Lodz
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Poland
State/province [41] 0 0
Lublin
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Poland
State/province [42] 0 0
Osielsko
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Poland
State/province [43] 0 0
Siedlce
Country [44] 0 0
Poland
State/province [44] 0 0
Skierniewice
Country [45] 0 0
Poland
State/province [45] 0 0
Warszawa
Country [46] 0 0
Poland
State/province [46] 0 0
Wroc?aw
Country [47] 0 0
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
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated
with BMS-986165
Trial website
https://clinicaltrials.gov/show/NCT02931838
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