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A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165 Dose 1 | Experimental | Specified dose of BMS-986165 on specified days. |
|
| BMS-986165 Dose 2 | Experimental | Specified dose of BMS-986165 on specified days. |
|
| BMS-986165 Dose 3 | Experimental | Specified dose of BMS-986165 on specified days. |
|
| BMS-986165 Dose 4 | Experimental | Specified dose of BMS-986165 on specified days. |
|
| BMS-986165 Dose 5 | Experimental | Specified dose of BMS-986165 on specified days. |
|
| Placebo | Placebo Comparator | Specified dose of Placebo for BMS-986165 on specified days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 85 |
| 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 | Day 1 to day 115 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39283417 | Derived | Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG. Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial. Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16. | |
| 35025062 |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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268 participants were randomized in the study; One participant was randomized but did not receive study drug due to being lost to follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for BMS-986165 |
| FG001 | BMS-986165 3MG QOD | BMS-986165 3mg capsules Every Other Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2016 | Oct 30, 2020 |
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| Placebo for BMS-986165 | Drug |
|
| Day 1 to Day 85 |
| 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. | Day 1 to Day 85 |
| 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) | Day 1 to Day 85 |
| 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. | Day 1 to Day 85 |
| 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 | Days 8, 15, 29, 57, 85 |
| San Diego |
| California |
| 92122 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Dermatologic Surgery Specialists, PC | Macon | Georgia | 31217 | United States |
| PMG Research of Christie Clinic, LLC | Champaign | Illinois | 61820 | United States |
| NorthShore University Health System | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location | Charlotte | North Carolina | 28277 | United States |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Wilmington, PLC | Wilmington | North Carolina | 28401 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Rivergate Dermatology Clinical Research Center, Pllc | Goodlettsville | Tennessee | 37072 | United States |
| Local Institution | Knoxville | Tennessee | 37920 | United States |
| Austin Dermatology Associates | Austin | Texas | 78705 | United States |
| Local Institution | Kogarah | New South Wales | 2217 | Australia |
| Local Institution | Wolloongabba | Queensland | 4102 | Australia |
| Local Institution | Melbourne | Victoria | 3053 | Australia |
| Local Institution | Nedlands | Western Australia | 6009 | Australia |
| Local Institution | Calgary | Alberta | T2G 1B1 | Canada |
| Local Institution | Edmonton | Alberta | T5K 1X3 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Local Institution | Hamilton | Ontario | L8N 1Y2 | Canada |
| Local Institution | Markham | Ontario | L3P 1X2 | Canada |
| Local Institution | Mississauga | Ontario | L5H 1G9 | Canada |
| Local Institution | Peterborough | Ontario | K9J 5K2 | Canada |
| Local Institution | Toronto | Ontario | M4W 2N2 | Canada |
| Local Institution | Waterloo | Ontario | N2J 1C4 | Canada |
| Local Institution | Windsor | Ontario | N8W 1E6 | Canada |
| Local Institution | Montreal | Quebec | H3H 1V4 | Canada |
| Local Institution | Dresden | 01097 | Germany |
| Local Institution | Gera | 07548 | Germany |
| Local Institution | Hamburg | 20253 | Germany |
| Local Institution | Hamburg | 20354 | Germany |
| Local Institution | Kiel | 24103 | Germany |
| Local Institution | Kiel | 24105 | Germany |
| Local Institution | Lübeck | 23538 | Germany |
| Local Institution | Mahlow | 15831 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Schwerin | 19055 | Germany |
| Local Institution | Stuttgart | 70178 | Germany |
| Local Institution | Nagoya | Aichi-ken | 4678602 | Japan |
| Local Institution | Fukuoka | Fukuoka | 814-0180 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0063 | Japan |
| Local Institution | Kobe | Hyōgo | 6500017 | Japan |
| Local Institution | Kamigyō-ku | Kyoto | 602-8566 | Japan |
| Local Institution | Shimotsuke-shi | Tochigi | 3290498 | Japan |
| Local Institution | Minato-ku | Tokyo | 105-8471 | Japan |
| Local Institution | Shinagawa-Ku | Tokyo | 141-8625 | Japan |
| Local Institution | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Local Institution | Skinjuku-ku | Tokyo | 1690073 | Japan |
| Local Institution | Kumamoto | 8608556 | Japan |
| Local Institution | Osaka | 5500012 | Japan |
| Local Institution | Tokyo | 1738606 | Japan |
| Local Institution | Daugavpils | LV-5404 | Latvia |
| Local Institution | Riga | LV-1001 | Latvia |
| Local Institution | Riga | LV-1003 | Latvia |
| Local Institution | Riga | LV-1011 | Latvia |
| Local Institution | Riga | LV-1013 | Latvia |
| Local Institution | Ventspils | LV3601 | Latvia |
| Local Institution | Zapopan | Jalisco | 45030 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Krakow | 31-011 | Poland |
| Local Institution | Lodz | 90-436 | Poland |
| Local Institution | Lublin | 20-080 | Poland |
| Local Institution | Osielsko | 86-031 | Poland |
| Local Institution | Siedlce | 08 - 110 | Poland |
| Local Institution | Skierniewice | 96-100 | Poland |
| Local Institution | Warsaw | 00-660 | Poland |
| Local Institution | Warsaw | 01-142 | Poland |
| Local Institution | Warsaw | 01-817 | Poland |
| Local Institution | Warsaw | 02-758 | Poland |
| Local Institution | Warsaw | 02-777 | Poland |
| Local Institution | Wroc?aw | 51-318 | Poland |
| Local Institution | Wroclaw | 50368 | Poland |
| 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. |
| 34767869 | Derived | 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. |
| 30205746 | Derived | 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. |
| FG002 |
| BMS-986165 3MG QD |
BMS-986165 3mg capsules Every Day |
| FG003 | BMS-986165 3MG BID | BMS-986165 3mg capsules Twice Daily |
| FG004 | BMS-986165 6MG BID | BMS-986165 6mg capsules Twice Daily |
| FG005 | BMS-986165 12MG QD | BMS-986165 12mg capsules Every Day |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo for BMS-986165 |
| BG001 | BMS-986165 3MG QOD | BMS-986165 3mg capsules Every Other Day |
| BG002 | BMS-986165 3MG QD | BMS-986165 3 mg capsules every day |
| BG003 | BMS-986165 3MG BID | BMS-986165 3 mg capsules twice daily |
| BG004 | BMS-986165 6MG BID | BMS-986165 6 mg capsules twice daily |
| BG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All randomized and treated participants | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | All randomized and treated participants | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | All randomized and treated participants | Count of Participants | Participants |
|
| 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 | 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. | All Randomized and Treated Participants | Posted | Number | 95% Confidence Interval | Percentage | Day 1 to Day 85 |
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| Secondary | 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. | All Randomized and Treated Participants | Posted | Number | 95% Confidence Interval | Percentage | Day 1 to Day 85 |
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| Secondary | 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. | All Randomized and Treated Participants | Posted | Number | 95% Confidence Interval | Percentage | Day 1 to Day 85 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | All Randomized and Treated Participants | Posted | Mean | 95% Confidence Interval | Score | Day 1 to Day 85 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All Randomized and Treated Participants | Posted | Mean | 95% Confidence Interval | Percentage | Day 1 to Day 85 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who received any study medication and have any available concentration-time data. | Posted | Mean | Standard Deviation | ng/mL | Days 8, 15, 29, 57, 85 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | All Randomized and Treated Participants | Posted | Count of Participants | Participants | Day 1 to day 115 |
|
20 weeks (assessed up to November 16, 2017)
All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo for BMS-986165 | 0 | 45 | 1 | 45 | 13 | 45 |
| EG001 | BMS-986165 3mg QOD | BMS-986165 3mg capsules Every Other Day | 0 | 44 | 1 | 44 | 14 | 44 |
| EG002 | BMS-986165 3mg QD | BMS-986165 3 mg capsules every day | 0 | 44 | 1 | 44 | 18 | 44 |
| EG003 | BMS-986165 3mg BID | BMS-986165 3 mg capsules twice daily | 0 | 45 | 1 | 45 | 15 | 45 |
| EG004 | BMS-986165 6mg BID | BMS-986165 6 mg capsules twice daily | 0 | 45 | 0 | 45 | 25 | 45 |
| EG005 | BMS-986165 12mg QD | BMS-986165 12 mg capsules every day | 0 | 44 | 0 | 44 | 19 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood immunoglobulin e increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
The limitations of this phase 2 trial include its small sample size and short duration; these results warrant confirmation in a larger trial of longer duration
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2017 | Oct 30, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. |
| 0.0003 |
Nominal p-value |
| Superiority |
| Chi-squared | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | <0.0001 | Nominal p-value | Superiority |
| Chi-squared | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | < 0.0001 | Nominal p-value | Superiority |
| Chi-squared | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | <0.0001 | Nominal p-value | Superiority |
| BMS-986165 3MG BID |
BMS-986165 3 mg capsules twice daily |
| OG004 | BMS-986165 6MG BID | BMS-986165 6 mg capsules twice daily |
| OG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
|
|
| OG004 | BMS-986165 6MG BID | BMS-986165 6 mg capsules twice daily |
| OG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
|
|
| OG004 |
| BMS-986165 6MG BID |
BMS-986165 6 mg capsules twice daily |
| OG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
|
|
BMS-986165 3 mg capsules twice daily
| OG004 | BMS-986165 6MG BID | BMS-986165 6 mg capsules twice daily |
| OG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
|
|
|
|
| OG005 | BMS-986165 12MG QD | BMS-986165 12 mg capsules every day |
|
|