Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004767-77 | EudraCT Number | ||
| U1111-1259-1220 | Registry Identifier | WHO |
Not provided
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Treatment BMS-986166 Dose 1 | Experimental |
| |
| Treatment BMS-986166 Dose 2 | Experimental |
| |
| Treatment BMS-986166 Dose 3 | Experimental |
| |
| Treatment Branebrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change From Baseline in EASI Score at Week 16 | The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better. | From baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16 | The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded). The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0091 | Fremont | California | 94538 | United States | ||
| Local Institution - 0112 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
17 participants randomized and treated
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Treatment 1 | BMS-986166 0.25mg POQD |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Branebrutinib | Drug | Specified dose on specified days |
|
|
| Placebo | Other | Specified dose on specified days |
|
| From baseline and 16 weeks |
| Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16 | The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better. | From baseline and 16 weeks |
| Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16 | Participants will complete a daily diary recording the intensity of their pruritus they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The lower the score the better. | From baseline and 16 weeks |
| Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16 | Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 ("the best possible sleep") to 10 ("the worst possible sleep). The lower the score the better. | From baseline and 16 weeks |
| Mean Change From Baseline in Percentage of Affected BSA at Week 16 | A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], genitals [1%]) and will be reported as a percentage of all major body sections combined. | From baseline and 16 weeks |
| Number of Participants With Mild Moderate or Severe AEs | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities. Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe. | From initial treatment to 30 days post discontinuation, approximately 29 weeks |
| Number of Participants With Mild Moderate or Severe SAEs | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:
| From initial treatment to 30 days post discontinuation, approximately 29 weeks |
| Number of Participants With Clinically Relevant ECG Abnormalities | 12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible. | Week 24 after initial treatment |
| Number of Participants With Clinically Relevant OCT Abnormalities | Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist. | Week 24 after initial treatment |
| Number of Participants With Clinically Relevant PFT Abnormalities | Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO). | Week 24 after initial treatment |
| Number of Participants With Clinically Meaningful Changes in Vital Signs | The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature. | Week 24 after initial treatment |
| Number of Participants With Clinically Relevant Changes in LFTs | Liver Function Tests (LFTs) will include the following measurements:
AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio | Week 24 after initial treatment |
| Brandon |
| Florida |
| 33511 |
| United States |
| Local Institution - 0061 | Coral Gables | Florida | 33134 | United States |
| Local Institution - 0110 | Margate | Florida | 33063 | United States |
| Local Institution - 0006 | Miami Lakes | Florida | 33014 | United States |
| Local Institution | Tampa | Florida | 33613 | United States |
| Local Institution - 0008 | Skokie | Illinois | 60077 | United States |
| Local Institution - 0081 | Indianapolis | Indiana | 46250 | United States |
| Local Institution - 0083 | Louisville | Kentucky | 40217 | United States |
| Dermatology and Skin Cancer Specialists, LLC | Rockville | Maryland | 20850 | United States |
| Local Institution - 0051 | Saint Joseph | Missouri | 64506 | United States |
| Local Institution | New York | New York | 10029 | United States |
| Local Institution - 0078 | Philadelphia | Pennsylvania | 19103 | United States |
| Local Institution - 0094 | Pittsburgh | Pennsylvania | 15213 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Local Institution | San Antonio | Texas | 78213 | United States |
| Local Institution - 0003 | Morgantown | West Virginia | 26505 | United States |
| Premier Dermatology | Kogarah | New South Wales | 2217 | Australia |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| Westmead Hospital-Dermatology | Westmead | New South Wales | 2145 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Local Institution | Linz | 4020 | Austria |
| Local Institution | Markham | Ontario | L3P 1X2 | Canada |
| York Dermatology Clinic and Research Centre | Richmond Hill | Ontario | L4C 9M7 | Canada |
| SIMa Recherche | Verdun | Quebec | H4G 3E7 | Canada |
| Charité Universitaetsmedizin Berlin - Campus Mitte | Berlin | 10117 | Germany |
| Local Institution | Berlin | 12459 | Germany |
| Local Institution - 0034 | Bochum | 44793 | Germany |
| Universitätsklinikum Bonn-Studienzentrum Dermatologie | Bonn | 53127 | Germany |
| SRH Wald-Klinikum Gera-Zentrum für klinische Studien | Gera | 07548 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Local Institution | Munich | 80337 | Germany |
| KliFOs - Klinische Forschung Osnabrück | Osnabrück | 49074 | Germany |
| Private Practice - Dr. Ralph von Kiedrowski | Selters | 56242 | Germany |
| Royalderm Agnieszka Nawrocka | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| NZOZ Centrum Medyczne KERmed | Bydgoszcz | 85-231 | Poland |
| ETYKA Osrodek Badan Klinicznych | Olsztyn | 10-117 | Poland |
| Local Institution - 0130 | Córdoba | Andalusia | 14004 | Spain |
| Hospital General Universitario de Alicante-Dermatology | Alicante | 03010 | Spain |
| Hospital Universitario de Gran Canaria Doctor NegrÃn-DermatologÃa | Las | 35010 | Spain |
| Hospital Universitario La Paz-UCICEC/DERMA | Madrid | 28046 | Spain |
| Treatment 2 |
BMS-986166 0.5mg POQD |
| FG003 | Treatment 3 | BMS-986166 0.75mg POQD |
| FG004 | Treatment 4 | Branebrutinib 9mg POQD |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Treatment 1 | BMS-986166 0.25mg POQD |
| BG002 | Treatment 2 | BMS-986166 0.5mg POQD |
| BG003 | Treatment 3 | BMS-986166 0.75mg POQD |
| BG004 | Treatment 4 | Branebrutinib 9mg POQD |
| BG005 | 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Mean Percentage Change From Baseline in EASI Score at Week 16 | The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better. | mITT population with evaluable EASI score at baseline and week 16. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Mean | Standard Deviation | Percentage change | From baseline and 16 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16 | The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded). The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed. | mITT population with evaluable vIGA-AD at baseline. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline and 16 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16 | The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better. | mITTpopulationIntent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline and 16 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16 | Participants will complete a daily diary recording the intensity of their pruritus they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The lower the score the better. | mITT population with evaluable baseline pruritis NRS greater than or equal to 4. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline and 16 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16 | Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 ("the best possible sleep") to 10 ("the worst possible sleep). The lower the score the better. | mITT population with evaluable Pruritus NRS at baseline and week 16. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Mean | Standard Deviation | Percentage change | From baseline and 16 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Percentage of Affected BSA at Week 16 | A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], genitals [1%]) and will be reported as a percentage of all major body sections combined. | mITT population with evaluable baseline and week 16 BSA measurement. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment) | Posted | Mean | Standard Deviation | Percentage change | From baseline and 16 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Mild Moderate or Severe AEs | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities. Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe. | Safety Population | Posted | Count of Participants | Participants | From initial treatment to 30 days post discontinuation, approximately 29 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Mild Moderate or Severe SAEs | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:
| Safety Population | Posted | Count of Participants | Participants | From initial treatment to 30 days post discontinuation, approximately 29 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant ECG Abnormalities | 12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible. | Safety Population | Posted | Count of Participants | Participants | Week 24 after initial treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant OCT Abnormalities | Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist. | Safety population | Posted | Count of Participants | Participants | Week 24 after initial treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant PFT Abnormalities | Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO). | Safety Population | Posted | Count of Participants | Participants | Week 24 after initial treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Meaningful Changes in Vital Signs | The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature. | Safety Population | Posted | Count of Participants | Participants | Week 24 after initial treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant Changes in LFTs | Liver Function Tests (LFTs) will include the following measurements:
AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio | Safety Population | Posted | Count of Participants | Participants | Week 24 after initial treatment |
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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 | 0 | 4 | 0 | 4 | 2 | 4 |
| EG001 | Treatment 1 | BMS-986166 0.25mg POQD | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Treatment 2 | BMS-986166 0.5mg POQD | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Treatment 3 | BMS-986166 0.75mg POQD | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | Treatment 4 | Branebrutinib 9mg POQD | 0 | 3 | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema herpeticum | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Aug 21, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
| C000710709 | branebrutinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
BMS-986166 0.75mg POQD
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
| OG003 | Treatment 3 | BMS-986166 0.75mg POQD |
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
BMS-986166 0.75mg POQD
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
| Treatment 3 |
BMS-986166 0.75mg POQD |
| OG004 | Treatment 4 | Branebrutinib 9mg POQD |
|
|
Branebrutinib 9mg POQD |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Branebrutinib 9mg POQD
|
|