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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004409-17 | EudraCT Number |
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The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1; Cohort 1 | Experimental | Participants, 6 to <12 years of age, will receive low dose of upadacitinib. |
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| Part 1; Cohort 2 | Experimental | Participants, 6 to <12 years of age, will receive high dose of upadacitinib. |
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| Part 1; Cohort 3 | Experimental | Participants, 2 to <6 years of age, will receive low dose of upadacitinib. |
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| Part 1; Cohort 4 | Experimental | Participants, 2 to <6 years of age, will receive high dose of upadacitinib. |
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| Part 2 | Experimental | Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib (ABT-494) | Drug | Upadacitinib will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib. | Up to 7 days |
| Time to Maximum Observed Plasma Concentration (Tmax) | It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib. | Up to 7 days |
| Area under the plasma concentration-time curve within a dosing interval (AUCtau) | The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma. | Up to 7 days |
| Oral Clearance | Clearance is defined the volume of plasma cleared of the drug per unit time. | Up to 7 days |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beach Pediatrics /ID# 207834 | Huntington Beach | California | 92647-6818 | United States | ||
| Children's Hospital Los Angeles /ID# 206042 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39142926 | Derived | Qian Y, Raymundo EM, Hao S, Unnebrink K, Levy GF, Teixeira HD, Chu AD, Zinn ZA, Paller AS, Liu W, Mohamed MF. Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Upadacitinib in Children with Severe Atopic Dermatitis. Clin Ther. 2024 Oct;46(10):733-741. doi: 10.1016/j.clinthera.2024.07.003. Epub 2024 Aug 13. |
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|
| Los Angeles |
| California |
| 90027 |
| United States |
| Pediatric Skin Research, LLC /ID# 213468 | Coral Gables | Florida | 33146-1837 | United States |
| Rybear, Inc /ID# 231801 | Fort Lauderdale | Florida | 33316-1952 | United States |
| IACT Health-Columbus /ID# 216370 | Columbus | Georgia | 31904-8946 | United States |
| Northwestern University Feinberg School of Medicine /ID# 206224 | Chicago | Illinois | 60611-2927 | United States |
| Dawes Fretzin, LLC /ID# 214958 | Indianapolis | Indiana | 46256 | United States |
| Duplicate_Washington University of St. Louis /ID# 206972 | St Louis | Missouri | 63141-6399 | United States |
| University of New Mexico School of Medicine /ID# 206757 | Albuquerque | New Mexico | 87131-0001 | United States |
| Cincinnati Children's Hospital /ID# 207071 | Cincinnati | Ohio | 45229 | United States |
| Oregon Medical Research Center /ID# 206226 | Portland | Oregon | 97239 | United States |
| Penn State University and Milton S. Hershey Medical Center /ID# 207096 | Hershey | Pennsylvania | 17033-2360 | United States |
| Paddington Testing Co., Inc. /ID# 207079 | Philadelphia | Pennsylvania | 19103 | United States |
| Arlington Research Center, Inc /ID# 222901 | Arlington | Texas | 76011 | United States |
| West Virginia University Hospitals /ID# 206792 | Morgantown | West Virginia | 26506 | United States |
| Haukeland University Hospital /ID# 210162 | Bergen | Hordaland | 5021 | Norway |
| Rikshospitalet OUS HF /ID# 210163 | Oslo | 0450 | Norway |
| Alma M. Cruz Santana, MD-Private practice /ID# 214890 | Carolina | 00985 | Puerto Rico |
| 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 |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
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