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| ID | Type | Description | Link |
|---|---|---|---|
| EPIONE | Other Identifier | Vanda Pharmaceuticals, Inc. |
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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Oral Capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Worst Itch in Atopic Dermatitis | Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable]. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Disease Severity in Atopic Dermatitis | Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Birmingham | Alabama | 35224 | United States | ||
| Vanda Investigational Site |
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| Label | URL |
|---|---|
| Study Webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant | Tradipitant: Oral Capsule |
| FG001 | Placebo | Placebo: Oral Capsule |
| 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 12, 2019 | Mar 19, 2024 |
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| Drug |
Oral Capsule |
|
| 8 weeks |
| Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction | As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting. | 8 weeks |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Vanda Investigational Site | Tempe | Arizona | 85283 | United States |
| Vanda Investigational Site | Encino | California | 91436 | United States |
| Vanda Investigational Site | Fountain Valley | California | 92708 | United States |
| Vanda Investigational Site | Fremont | California | 94538 | United States |
| Vanda Investigational Site | Laguna Hills | California | 92653 | United States |
| Vanda Investigational Site | Lomita | California | 90717 | United States |
| Vanda Investigational Site | Long Beach | California | 90806 | United States |
| Vanda Investigational Site | Los Angeles | California | 90017 | United States |
| Vanda Investigational Site | Los Angeles | California | 90036 | United States |
| Vanda Investigational Site | San Diego | California | 92122 | United States |
| Vanda Investigational Site | Santa Monica | California | 90404 | United States |
| Vanda Investigational Site | Denver | Colorado | 80220 | United States |
| Vanda Investigational Site | Aventura | Florida | 33180 | United States |
| Vanda Investigational Site | Clearwater | Florida | 33756 | United States |
| Vanda Investigational Site | Fort Lauderdale | Florida | 33306 | United States |
| Vanda Investigational Site | Hialeah | Florida | 33016 | United States |
| Vanda Investigational Site | Miami | Florida | 33126 | United States |
| Vanda Investigational Site | Miami | Florida | 33137 | United States |
| Vanda Investigational Site | Miramar | Florida | 33027 | United States |
| Vanda Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Vanda Investigational Site | South Miami | Florida | 33143 | United States |
| Vanda Investigational Site | Tampa | Florida | 33613 | United States |
| Vanda Investigational Site | Savannah | Georgia | 31406 | United States |
| Vanda Investigational Site | Boise | Idaho | 83704 | United States |
| Vanda Investigational Site | Normal | Illinois | 61761 | United States |
| Vanda Investigational Site | Skokie | Illinois | 60077 | United States |
| Vanda Investigational Site | Plainfield | Indiana | 46168 | United States |
| Vanda Investigational Site | Crowley | Louisiana | 70526 | United States |
| Vanda Investigational Site | Rockville | Maryland | 20850 | United States |
| Vanda Investigational Site | Towson | Maryland | 21204 | United States |
| Vanda Investigational Site | Beverly | Massachusetts | 01915 | United States |
| Vanda Investigational Site | Brighton | Massachusetts | 02135 | United States |
| Vanda Investigational Site | Fort Gratiot | Michigan | 48059 | United States |
| Vanda Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Vanda Investigational Site | St Louis | Missouri | 63141 | United States |
| Vanda Investigational Site | Omaha | Nebraska | 68144 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Vanda Investigational Site | Berlin | New Jersey | 08009 | United States |
| Vanda Investigational Site | Verona | New Jersey | 07044 | United States |
| Vanda Investigational Site | Brooklyn | New York | 11201 | United States |
| Vanda Investigational Site | New York | New York | 10003 | United States |
| Vanda Investigational Site | New York | New York | 10022 | United States |
| Vanda Investigational Site | New York | New York | 10075 | United States |
| Vanda Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Vanda Investigational Site | High Point | North Carolina | 27262 | United States |
| Vanda Investigational Site | Wilmington | North Carolina | 28405 | United States |
| Vanda Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Vanda Investigational Site | Dayton | Ohio | 45414 | United States |
| Vanda Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Vanda Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Vanda Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Vanda Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanda Investigational Site | Johnston | Rhode Island | 02919 | United States |
| Vanda Investigational Site | North Charleston | South Carolina | 29420 | United States |
| Vanda Investigational Site | Spartanburg | South Carolina | 29301 | United States |
| Vanda Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| Vanda Investigational Site | Nashville | Tennessee | 37211 | United States |
| Vanda Investigational Site | Dallas | Texas | 75230 | United States |
| Vanda Investigational Site | Pflugerville | Texas | 78660 | United States |
| Vanda Investigational Site | San Antonio | Texas | 78213 | United States |
| Vanda Investigational Site | San Antonio | Texas | 78218 | United States |
| Vanda Investigational Site | West Jordan | Utah | 84088 | United States |
| Vanda Investigational Site | South Burlington | Vermont | 05403 | United States |
| Vanda Investigational Site | Newport News | Virginia | 23606 | United States |
| Vanda Investigational Site | Norfolk | Virginia | 23507 | United States |
| Vanda Investigational Site | Richmond | Virginia | 23233 | United States |
| Vanda Investigational Site | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant | Tradipitant: Oral Capsule |
| BG001 | Placebo | Placebo: Oral Capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Worst Itch Numeric Rating Scale (NRS) Score | Mean | Standard Deviation | units on a scale |
| |||||||||||||||
| SCORing Atopic Dermatitis (SCORAD) Index | Mean | Standard Deviation | units on a scale |
| |||||||||||||||
| Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score | Number analyzed in row differs from overall due to availability of data. | Count of Participants | Participants |
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| 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 | Reduction of Worst Itch in Atopic Dermatitis | Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable]. | All participants randomized (1:1) to placebo or tradipitant. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Improvement of Disease Severity in Atopic Dermatitis | Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease). | All participants randomized (1:1) to placebo or tradipitant. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction | As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting. | All participants randomized (1:1) to placebo or tradipitant. | Posted | Count of Participants | Participants | 8 weeks |
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| Post-Hoc | Reduction of Worst Itch in Atopic Dermatitis as Measured by Numerical Rating Scale (NRS), Adjusted for Investigator Global Assessment (IGA) | Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable]. | Participants rated 1 or 2 by the IGA, randomized (1:1) to placebo or tradipitant. | Posted | Mean | 95% Confidence Interval | units on a scale | 2 weeks |
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| Post-Hoc | Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment | SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease). | Participants rated 1 or 2 by the IGA scale, randomized (1:1) to placebo or tradipitant. | Posted | Mean | 95% Confidence Interval | units on a scale | 2 weeks |
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All Adverse Events (AEs) were collected from signature of the informed consent up to the final visit (Week 8) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tradipitant | Tradipitant: Oral Capsule | 0 | 188 | 2 | 188 | 23 | 188 |
| EG001 | Placebo | Placebo: Oral Capsule | 0 | 187 | 1 | 187 | 11 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extradural abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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PI is restricted from presenting or publishing independently until the expiration of eighteen (18) months from the completion of the Clinical Trial or as otherwise noted in the Investigator's clinical trial agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 202-734-3400 | clinicaltrials@vandapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2019 | Mar 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
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