search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Upadacitinib (ABT-494)
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Upadacitinib, ABT-494, Atopic Dermatitis, RINVOQ

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Beach Pediatrics /ID# 207834
  • Children's Hospital Los Angeles /ID# 206042
  • Pediatric Skin Research, LLC /ID# 213468
  • Rybear, Inc /ID# 231801
  • IACT Health-Columbus /ID# 216370
  • Northwestern University Feinberg School of Medicine /ID# 206224
  • Dawes Fretzin, LLC /ID# 214958
  • Washington University of St. Louis /ID# 206972
  • University of New Mexico School of Medicine /ID# 206757
  • Cincinnati Children's Hospital /ID# 207071
  • Oregon Health and Science University /ID# 206226
  • Penn State University and Milton S. Hershey Medical Center /ID# 207096
  • Paddington Testing Co., Inc. /ID# 207079
  • Arlington Research Center, Inc /ID# 222901
  • West Virginia University Hospitals /ID# 206792
  • Haukeland University Hospital /ID# 210162
  • Rikshospitalet OUS HF /ID# 210163
  • Cruz-Santana, Carolina, PR /ID# 214890

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1; Cohort 1

Part 1; Cohort 2

Part 1; Cohort 3

Part 1; Cohort 4

Part 2

Arm Description

Participants, 6 to <12 years of age, will receive low dose of upadacitinib.

Participants, 6 to <12 years of age, will receive high dose of upadacitinib.

Participants, 2 to <6 years of age, will receive low dose of upadacitinib.

Participants, 2 to <6 years of age, will receive high dose of upadacitinib.

Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time to Maximum Observed Plasma Concentration (Tmax)
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)
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
Clearance is defined the volume of plasma cleared of the drug per unit time.
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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2018
Last Updated
January 25, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT03646604
Brief Title
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
Official Title
An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
August 23, 2024 (Anticipated)
Study Completion Date
August 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Upadacitinib, ABT-494, Atopic Dermatitis, RINVOQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1; Cohort 1
Arm Type
Experimental
Arm Description
Participants, 6 to <12 years of age, will receive low dose of upadacitinib.
Arm Title
Part 1; Cohort 2
Arm Type
Experimental
Arm Description
Participants, 6 to <12 years of age, will receive high dose of upadacitinib.
Arm Title
Part 1; Cohort 3
Arm Type
Experimental
Arm Description
Participants, 2 to <6 years of age, will receive low dose of upadacitinib.
Arm Title
Part 1; Cohort 4
Arm Type
Experimental
Arm Description
Participants, 2 to <6 years of age, will receive high dose of upadacitinib.
Arm Title
Part 2
Arm Type
Experimental
Arm Description
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib (ABT-494)
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Upadacitinib will be administered orally.
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time Frame
Up to 7 days
Title
Time to Maximum Observed Plasma Concentration (Tmax)
Description
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Time Frame
Up to 7 days
Title
Area under the plasma concentration-time curve within a dosing interval (AUCtau)
Description
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
Title
Oral Clearance
Description
Clearance is defined the volume of plasma cleared of the drug per unit time.
Time Frame
Up to 7 days
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Beach Pediatrics /ID# 207834
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647-6818
Country
United States
Facility Name
Children's Hospital Los Angeles /ID# 206042
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Pediatric Skin Research, LLC /ID# 213468
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146-1837
Country
United States
Facility Name
Rybear, Inc /ID# 231801
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316-1952
Country
United States
Facility Name
IACT Health-Columbus /ID# 216370
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8946
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 206224
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 214958
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Washington University of St. Louis /ID# 206972
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141-6399
Country
United States
Facility Name
University of New Mexico School of Medicine /ID# 206757
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Cincinnati Children's Hospital /ID# 207071
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Oregon Health and Science University /ID# 206226
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 207096
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Paddington Testing Co., Inc. /ID# 207079
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 222901
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
West Virginia University Hospitals /ID# 206792
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Haukeland University Hospital /ID# 210162
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Rikshospitalet OUS HF /ID# 210163
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Cruz-Santana, Carolina, PR /ID# 214890
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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

We'll reach out to this number within 24 hrs