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

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03646604

Collaborator

(none)

Enrollment

Locations

Arms

67.7

Anticipated Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Upadacitinib (ABT-494)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2019

Anticipated Primary Completion Date :

Sep 23, 2024

Anticipated Study Completion Date :

Sep 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1; Cohort 1 Participants, 6 to <12 years of age, will receive low dose of upadacitinib.	Drug: Upadacitinib (ABT-494) Upadacitinib will be administered orally. Other Names: ABT-494 RINVOQ
Experimental: Part 1; Cohort 2 Participants, 6 to <12 years of age, will receive high dose of upadacitinib.	Drug: Upadacitinib (ABT-494) Upadacitinib will be administered orally. Other Names: ABT-494 RINVOQ
Experimental: Part 1; Cohort 3 Participants, 2 to <6 years of age, will receive low dose of upadacitinib.	Drug: Upadacitinib (ABT-494) Upadacitinib will be administered orally. Other Names: ABT-494 RINVOQ
Experimental: Part 1; Cohort 4 Participants, 2 to <6 years of age, will receive high dose of upadacitinib.	Drug: Upadacitinib (ABT-494) Upadacitinib will be administered orally. Other Names: ABT-494 RINVOQ
Experimental: Part 2 Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.	Drug: Upadacitinib (ABT-494) Upadacitinib will be administered orally. Other Names: ABT-494 RINVOQ

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) [Up to 7 days]
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time to Maximum Observed Plasma Concentration (Tmax) [Up to 7 days]
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Area under the plasma concentration-time curve within a dosing interval (AUCtau) [Up to 7 days]
The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.
Oral Clearance [Up to 7 days]
Clearance is defined the volume of plasma cleared of the drug per unit time.
Number of Participants With Treatment Emergent Adverse Events (TEAE) [Up to 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beach Pediatrics /ID# 207834	Huntington Beach	California	United States	92647-6818
2	Childrens Hospital LA /ID# 206042	Los Angeles	California	United States	90027
3	Pediatric Skin Research, LLC /ID# 213468	Coral Gables	Florida	United States	33146-1837
4	Rybear, Inc /ID# 231801	Fort Lauderdale	Florida	United States	33316-1952
5	IACT Health-Columbus /ID# 216370	Columbus	Georgia	United States	31904-8946
6	Northwestern University Feinberg School of Medicine /ID# 206224	Chicago	Illinois	United States	60611-2927
7	Dawes Fretzin, LLC /ID# 214958	Indianapolis	Indiana	United States	46256
8	Washington University of St. Louis /ID# 206972	Saint Louis	Missouri	United States	63141-6399
9	University of New Mexico School of Medicine /ID# 206757	Albuquerque	New Mexico	United States	87131-0001
10	Cincinnati Children's Hospital /ID# 207071	Cincinnati	Ohio	United States	45229
11	Oregon Health and Science University /ID# 206226	Portland	Oregon	United States	97239
12	Penn State University and Milton S. Hershey Medical Center /ID# 207096	Hershey	Pennsylvania	United States	17033-2360
13	Paddington Testing Co., Inc. /ID# 207079	Philadelphia	Pennsylvania	United States	19103
14	Arlington Research Center, Inc /ID# 222901	Arlington	Texas	United States	76011
15	West Virginia University Hospitals /ID# 206792	Morgantown	West Virginia	United States	26506
16	Haukeland University Hospital /ID# 210162	Bergen	Hordaland	Norway	5021
17	Rikshospitalet OUS HF /ID# 210163	Oslo		Norway	0450
18	Cruz-Santana, Carolina, PR /ID# 214890	Carolina		Puerto Rico	00985