A Phase 1 interventional study of Upadacitinib (ABT-494) in Atopic Dermatitis, sponsored by AbbVie. Completed at 18 sites in 3 countries. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 35 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants, 6 to \<12 years of age, will receive low dose of upadacitinib.
Drug: Upadacitinib (ABT-494)
Participants, 6 to \<12 years of age, will receive high dose of upadacitinib.
Drug: Upadacitinib (ABT-494)
Participants, 2 to \<6 years of age, will receive low dose of upadacitinib.
Drug: Upadacitinib (ABT-494)
Participants, 2 to \<6 years of age, will receive high dose of upadacitinib.
Drug: Upadacitinib (ABT-494)
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Also known as: ABT-494, RINVOQ
Maximum Plasma Concentration (Cmax)
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time frame: Up to 7 days
Time to Maximum Observed Plasma Concentration (Tmax)
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Time frame: 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.
Time frame: Up to 7 days
Oral Clearance
Clearance is defined the volume of plasma cleared of the drug per unit time.
Time frame: 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.
Time frame: Up to 2 years
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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