A Study to Evaluate Effectiveness and Safety of Deucravac... | NCT06042920 | Trialant
NCT06042920
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
Apr 17, 2026Actual
Enrollment
130Actual
Phase
Phase 4
Conditions
Palmoplantar Psoriasis
Genital Psoriasis
Interventions
Deucravacitinib
Placebo
Countries
United States
Argentina
Canada
Protocol Section
Identification Module
NCT ID
NCT06042920
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-1112
Secondary IDs
ID
Type
Description
Link
2023-504663-16
EudraCT Number
U1111-1289-6934
Registry Identifier
WHO Universal Trial Number (UTN)
Brief Title
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Official Title
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business objectives have changed
Expanded Access Info
No
Start Date
Oct 9, 2023Actual
Primary Completion Date
Apr 25, 2025Actual
Completion Date
Apr 25, 2025Actual
First Submitted Date
Sep 12, 2023
First Submission Date that Met QC Criteria
Sep 12, 2023
First Posted Date
Sep 21, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2026
Results First Submitted that Met QC Criteria
Mar 27, 2026
Results First Posted Date
Apr 17, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 27, 2026
Last Update Posted Date
Apr 17, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Palmoplantar Psoriasis
Genital Psoriasis
Keywords
Deucravacitinib
BMS-986165
SOTYKTU
Plaque psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
130Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Deucravacitinib
Experimental
Drug: Deucravacitinib
Placebo followed by Deucravacitinib
Placebo Comparator
Drug: Deucravacitinib
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Deucravacitinib
Drug
Specified dose on specified days
Deucravacitinib
Placebo followed by Deucravacitinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Week 16
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
The Palmoplantar Physician's Global Assessment (pp-PGA) is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The pp-PGA 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis
Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1.
A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy.
Inclusion Criteria for Genital Psoriasis
Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1.
Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1.
Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
Failed to respond to, or intolerant of ≥ 1 topical therapy.
Key Exclusion Criteria:
Target Disease Exceptions
Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1.
Other protocol-defined inclusion/exclusion criteria apply.
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at:
Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16
The Genital Psoriasis Symptoms Scale (GPSS) is a participant-administered questionnaire that contains 8 items regarding GenPs symptoms and has a recall period of 24 hours. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents "no symptom" and 10 represents "worst symptom imaginable". A total score ranging from 0 (no GenPs symptoms) to 80 (worst imaginable GenPs symptoms)
Week 16
Number of Participants With Adverse Events
Adverse Events (AEs) are any new or worsening medical occurrences in participants receiving study treatment, regardless of whether they are related to the treatment. AEs include any unfavorable and unintended sign, symptom, or disease temporally associated with treatment. Serious Adverse Events (SAEs) are defined as events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability, are congenital anomalies/birth defects, or are otherwise medically significant.
Week 0 through Week 16
Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results
Blood samples were collected to assess the laboratory parameters. Laboratory toxicities are graded using NCI CTCAE v3.0. Grade 3 and 4 represent severe and life-threatening abnormalities, respectively.
Week 0 through Week 16
Number of Participants With Vital Sign Summaries Per Categories
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Heart rate was measured in beats/min and DBP and SBP was measured in mmHG.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
FG003
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
FG004
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
FG005
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
FG006
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
FG007
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
BG003
Placebo Contolled - Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00115
BG00256
BG00329
BG004130
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
HISPANIC OR LATINO
Title
Measurements
BG0009
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Full Analysis Set. Pre-defined to be only assessed for Palmoplantar Psoriasis arms. Only number of participants with data available were included in the analysis.
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
Units
Counts
Participants
OG00016
OG0019
Title
Denominators
Categories
Title
Measurements
OG00031.3(11.0 to 58.7)
OG00133.3(7.5 to 70.1)
Primary
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Full Analysis Set. Pre-defined to be only assessed for Genital Psoriasis arms. Only number of participants with data available were included in the analysis.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
OG001
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
Units
Counts
Secondary
Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
The Palmoplantar Physician's Global Assessment (pp-PGA) is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The pp-PGA 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Full Analysis Set. Pre-defined to be only assessed for Palmoplantar Psoriasis arms. Only number of participants with data available were included in the analysis.
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
Secondary
Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16
The Genital Psoriasis Symptoms Scale (GPSS) is a participant-administered questionnaire that contains 8 items regarding GenPs symptoms and has a recall period of 24 hours. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents "no symptom" and 10 represents "worst symptom imaginable". A total score ranging from 0 (no GenPs symptoms) to 80 (worst imaginable GenPs symptoms)
Full Analysis Set. Pre-defined to be only assessed for Genital Psoriasis arms. Only number of participants with data available were included in the analysis.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
OG001
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
Units
Counts
Secondary
Number of Participants With Adverse Events
Adverse Events (AEs) are any new or worsening medical occurrences in participants receiving study treatment, regardless of whether they are related to the treatment. AEs include any unfavorable and unintended sign, symptom, or disease temporally associated with treatment. Serious Adverse Events (SAEs) are defined as events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability, are congenital anomalies/birth defects, or are otherwise medically significant.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
Secondary
Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results
Blood samples were collected to assess the laboratory parameters. Laboratory toxicities are graded using NCI CTCAE v3.0. Grade 3 and 4 represent severe and life-threatening abnormalities, respectively.
As-treated population. Only number of participants with data available were included in the analysis.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
OG003
Secondary
Number of Participants With Vital Sign Summaries Per Categories
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Heart rate was measured in beats/min and DBP and SBP was measured in mmHG.
As-treated population. Only number of participants with data available were included in the analysis.
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
0
56
1
56
10
56
EG003
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
0
29
0
29
10
29
EG004
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
0
13
1
13
2
13
EG005
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
0
8
2
8
1
8
EG006
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
0
29
4
29
7
29
EG007
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
0
10
0
10
2
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0021 affected56 at risk
EG0030 affected29 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected29 at risk
EG0070 affected10 at risk
Coronary artery occlusion
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG0032 affected29 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected29 at risk
EG0070 affected10 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
COVID-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected15 at risk
EG0022 affected56 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0021 affected56 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected15 at risk
EG0022 affected56 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected15 at risk
EG0021 affected56 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0021 affected56 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Liver function test increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Depression
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected15 at risk
EG0020 affected56 at risk
EG003
Hypertension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected15 at risk
EG0023 affected56 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected15 at risk
EG0020 affected56 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication