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

February 6, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0450
        • Rikshospitalet OUS HF /ID# 210163
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland University Hospital /ID# 210162
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Alma M. Cruz Santana, MD-Private practice /ID# 214890
  • United States
    • California
      • Huntington Beach, California, United States, 92647-6818
        • Beach Pediatrics /ID# 207834
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles /ID# 206042
    • Florida
      • Coral Gables, Florida, United States, 33146-1837
        • Pediatric Skin Research, LLC /ID# 213468
      • Fort Lauderdale, Florida, United States, 33316-1952
        • Rybear, Inc /ID# 231801
    • Georgia
      • Columbus, Georgia, United States, 31904-8946
        • IACT Health-Columbus /ID# 216370
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 206224
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin, LLC /ID# 214958
    • Missouri
      • Saint Louis, Missouri, United States, 63141-6399
        • Duplicate_Washington University of St. Louis /ID# 206972
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico School of Medicine /ID# 206757
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital /ID# 207071
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Medical Research Center /ID# 206226
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-2360
        • Penn State University and Milton S. Hershey Medical Center /ID# 207096
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co., Inc. /ID# 207079
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc /ID# 222901
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals /ID# 206792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • RINVOQ
  • ABT-494
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:
  • RINVOQ
  • ABT-494
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:
  • RINVOQ
  • ABT-494
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:
  • RINVOQ
  • ABT-494
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:
  • RINVOQ
  • ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: Up to 7 days
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Up to 7 days
Time to Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to 7 days
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)
Time Frame: 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.
Up to 7 days
Oral Clearance
Time Frame: Up to 7 days
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)
Time Frame: 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.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2019

Primary Completion (Actual)

August 29, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-049
  • 2018-004409-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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