A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03646604
• Other study ID #: M16-049
• Secondary ID: 2018-004409-17
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 31, 2019
• Est. completion date: August 23, 2024

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
• Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.
• Meets Hanifin and Rajka criteria for AD.
• Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).
• Documented history (within 12 months prior to the Baseline Visit) of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable.

Exclusion Criteria:

• Prior exposure to Janus Kinase (JAK) inhibitor.
• Requirement of prohibited medications during the study.
• Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Upadacitinib (ABT-494)
Upadacitinib will be administered orally.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital /ID# 210162	Bergen	Hordaland
Norway	Rikshospitalet OUS HF /ID# 210163	Oslo
Puerto Rico	Cruz-Santana, Carolina, PR /ID# 214890	Carolina
United States	University of New Mexico School of Medicine /ID# 206757	Albuquerque	New Mexico
United States	Arlington Research Center, Inc /ID# 222901	Arlington	Texas
United States	Northwestern University Feinberg School of Medicine /ID# 206224	Chicago	Illinois
United States	Cincinnati Children's Hospital /ID# 207071	Cincinnati	Ohio
United States	IACT Health-Columbus /ID# 216370	Columbus	Georgia
United States	Pediatric Skin Research, LLC /ID# 213468	Coral Gables	Florida
United States	Rybear, Inc /ID# 231801	Fort Lauderdale	Florida
United States	Penn State University and Milton S. Hershey Medical Center /ID# 207096	Hershey	Pennsylvania
United States	Beach Pediatrics /ID# 207834	Huntington Beach	California
United States	Dawes Fretzin, LLC /ID# 214958	Indianapolis	Indiana
United States	Children's Hospital Los Angeles /ID# 206042	Los Angeles	California
United States	West Virginia University Hospitals /ID# 206792	Morgantown	West Virginia
United States	Paddington Testing Co., Inc. /ID# 207079	Philadelphia	Pennsylvania
United States	Oregon Health and Science University /ID# 206226	Portland	Oregon
United States	Washington University of St. Louis /ID# 206972	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Norway,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.	Up to 7 days
Primary	Time to Maximum Observed Plasma Concentration (Tmax)	It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.	Up to 7 days
Primary	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
Primary	Oral Clearance	Clearance is defined the volume of plasma cleared of the drug per unit time.	Up to 7 days
Primary	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

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.