Back to resultsStudy to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo for BMS-986165
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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.
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
Sites / Locations
- University of California Irvine
- University of California San Diego
- Renstar Medical Research
- Dermatologic Surgery Specialists, PC
- PMG Research of Christie Clinic, LLC
- NorthShore University Health System
- Dawes Fretzin Clinical Research Group, LLC
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
- Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
- PMG Research of Rocky Mount, LLC
- PMG Research of Wilmington, PLC
- Central Sooner Research
- Health Concepts
- Rivergate Dermatology Clinical Research Center, Pllc
- Local Institution
- Austin Dermatology Associates
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BMS-986165 Dose 1
BMS-986165 Dose 2
BMS-986165 Dose 3
BMS-986165 Dose 4
BMS-986165 Dose 5
Placebo
Arm Description
Specified dose of BMS-986165 on specified days.
Specified dose of BMS-986165 on specified days.
Specified dose of BMS-986165 on specified days.
Specified dose of BMS-986165 on specified days.
Specified dose of BMS-986165 on specified days.
Specified dose of Placebo for BMS-986165 on specified days.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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.
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)
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02931838
Brief Title
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986165 Dose 1
Arm Type
Experimental
Arm Description
Specified dose of BMS-986165 on specified days.
Arm Title
BMS-986165 Dose 2
Arm Type
Experimental
Arm Description
Specified dose of BMS-986165 on specified days.
Arm Title
BMS-986165 Dose 3
Arm Type
Experimental
Arm Description
Specified dose of BMS-986165 on specified days.
Arm Title
BMS-986165 Dose 4
Arm Type
Experimental
Arm Description
Specified dose of BMS-986165 on specified days.
Arm Title
BMS-986165 Dose 5
Arm Type
Experimental
Arm Description
Specified dose of BMS-986165 on specified days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Specified dose of Placebo for BMS-986165 on specified days.
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Type
Drug
Intervention Name(s)
Placebo for BMS-986165
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Day 1 to Day 85
Title
Number of Participants With Adverse Events
Description
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
Time Frame
Day 1 to day 115
Secondary Outcome Measure Information:
Title
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Description
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.
Time Frame
Day 1 to Day 85
Title
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Description
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.
Time Frame
Day 1 to Day 85
Title
Change From Baseline in DLQI Scores on Day 85
Description
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)
Time Frame
Day 1 to Day 85
Title
Change From Baseline in BSA on Day 85
Description
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.
Time Frame
Day 1 to Day 85
Title
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Description
Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Time Frame
Days 8, 15, 29, 57, 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Dermatologic Surgery Specialists, PC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
PMG Research of Christie Clinic, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
NorthShore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
PMG Research of Wilmington, PLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Rivergate Dermatology Clinical Research Center, Pllc
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Local Institution
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Austin Dermatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution
City
Wolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Local Institution
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Local Institution
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Local Institution
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
Local Institution
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Local Institution
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01097
Country
Germany
Facility Name
Local Institution
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24103
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Local Institution
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Fukuoka City
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Local Institution
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Local Institution
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Facility Name
Local Institution
City
Kamigyo-ku
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Local Institution
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Local Institution
City
Shinagawa-Ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Local Institution
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Local Institution
City
Skinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1690073
Country
Japan
Facility Name
Local Institution
City
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution
City
Osaka
ZIP/Postal Code
5500012
Country
Japan
Facility Name
Local Institution
City
Tokyo
ZIP/Postal Code
1738606
Country
Japan
Facility Name
Local Institution
City
Daugavpils
ZIP/Postal Code
LV-5404
Country
Latvia
Facility Name
Local Institution
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Local Institution
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Local Institution
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Local Institution
City
Riga
ZIP/Postal Code
LV-1013
Country
Latvia
Facility Name
Local Institution
City
Ventspils
ZIP/Postal Code
LV3601
Country
Latvia
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Local Institution
City
Monterey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Local Institution
City
Osielsko
ZIP/Postal Code
86-031
Country
Poland
Facility Name
Local Institution
City
Siedlce
ZIP/Postal Code
08 - 110
Country
Poland
Facility Name
Local Institution
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
00-660
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Local Institution
City
Wroc?aw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50368
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35025062
Citation
Thaci D, Strober B, Gordon KB, Foley P, Gooderham M, Morita A, Papp KA, Puig L, Menter MA, Colombo MJ, Elbez Y, Kisa RM, Ye J, Napoli AA, Wei L, Banerjee S, Merola JF, Gottlieb AB. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatol Ther (Heidelb). 2022 Feb;12(2):495-510. doi: 10.1007/s13555-021-00649-y. Epub 2022 Jan 13.
Results Reference
derived
PubMed Identifier
34767869
Citation
Catlett IM, Hu Y, Gao L, Banerjee S, Gordon K, Krueger JG. Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. J Allergy Clin Immunol. 2022 Jun;149(6):2010-2020.e8. doi: 10.1016/j.jaci.2021.11.001. Epub 2021 Nov 10.
Results Reference
derived
PubMed Identifier
30205746
Citation
Papp K, Gordon K, Thaci D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
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Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
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