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The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group : Ruxolitinib | Experimental | ruxolitinib cream 1.5% will be applied twice daily as a thin film. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ruxolitinib cream | Drug | ruxolitinib cream 1.5% will be applied twice daily as a thin film |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application) | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | Baseline; Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). |
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Inclusion Criteria:
Exclusion Criteria:
Participant had significant flares or unstable course in AD.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada | ||
| Innovoderm Research |
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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This study was conducted at 1 study center in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application) | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | Modified Intent-to Treat (mITT) Population: all participants who had both a Baseline and at least 1 post-Baseline PP-NRS or modified PP-NRS (mPP-NRS) assessment within the treatment period. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Day 2 |
|
up to Day 43
Treatment-emergent adverse events (TEAEs), defined as any adverse events with an onset date during or after the first study treatment dose, have been reported for all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream (Safety Analysis Set).
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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 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
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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 | May 9, 2022 | Oct 3, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2022 | Oct 3, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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Open Label
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| Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
| Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application) | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | Baseline; Day 3 through Day 29 |
| Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). Confidence intervals were calculated using the Clopper-Pearson method. | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
| Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | Baseline; Day 2 through Day 29 |
| Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
| Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | Baseline; Day 2 through Day 29 |
| Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline ) | The MCID corresponds to an achievement of a ≥2-grade reduction in PP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | from Baseline up to Day 29 |
| Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline) | The MCID corresponds to an achievement of a ≥2-grade reduction in mPP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). | Baseline; Day 1 |
| Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29 | The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | Baseline; Days 8, 15, and 29 |
| Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29 | The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade reduction from Baseline. The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | Baseline; Days 8, 15, and 29 |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. | up to Day 43 |
| Number of Participants With Any Grade 3 or Higher TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to Day 43 |
| Montreal |
| Quebec |
| H2K 4LS |
| Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 28 days. |
|
|
| Secondary | Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). | mITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
|
|
|
| Secondary | Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application) | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | mITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Day 3 through Day 29 |
|
|
|
| Secondary | Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). Confidence intervals were calculated using the Clopper-Pearson method. | mITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
|
|
|
| Secondary | Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | mITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Day 2 through Day 29 |
|
|
|
| Secondary | Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 | On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). | mITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose) |
|
|
|
| Secondary | Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 | The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | mITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Day 2 through Day 29 |
|
|
|
| Secondary | Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline ) | The MCID corresponds to an achievement of a ≥2-grade reduction in PP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period. | mITT Population | Posted | Mean | Standard Deviation | days | from Baseline up to Day 29 |
|
|
|
| Secondary | Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline) | The MCID corresponds to an achievement of a ≥2-grade reduction in mPP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). | mITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | hours | Baseline; Day 1 |
|
|
|
| Secondary | Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29 | The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | mITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Days 8, 15, and 29 |
|
|
|
| Secondary | Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29 | The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade reduction from Baseline. The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting. | mITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Days 8, 15, and 29 |
|
|
|
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. | Safety Analysis Set: all enrolled participants who received at least 1 application of ruxolitinib 1.5% cream. | Posted | Number | participants | up to Day 43 |
|
|
|
| Secondary | Number of Participants With Any Grade 3 or Higher TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Safety Analysis Set | Posted | Number | participants | up to Day 43 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 15 |
| 49 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 24 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change from Baseline at 30 minutes postdose |
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| Day 24 |
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| Day 25 |
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| Day 26 |
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| Day 27 |
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| Day 28 |
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| Day 29 |
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| 1 hour postdose |
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| 2 hours postdose |
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| 4 hours postdose |
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| 6 hours postdose |
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| 12 hours postdose |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
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| Day 11 |
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| Day 12 |
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| Day 13 |
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| Day 14 |
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| Day 15 |
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| Day 16 |
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| Day 17 |
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| Day 18 |
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| Day 19 |
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| Day 20 |
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| Day 21 |
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| Day 22 |
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| Day 23 |
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| Day 24 |
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| Day 25 |
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| Day 26 |
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| Day 27 |
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| Day 28 |
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| Day 29 |
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| Change from Baseline at Day 15 |
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| Change from Baseline at Day 29 |
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| Day 29 |
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