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

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ClinicalTrials.gov Identifier: NCT03646604
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The primary objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric subjects with severe atopic dermatitis.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 31, 2019
Estimated Primary Completion Date : December 29, 2021
Estimated Study Completion Date : January 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cohort 1
Study participants, 6 to <12 years of age, receiving low dose of upadacitinib
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Name: ABT-494

Experimental: Cohort 2
Study participants, 6 to <12 years of age, receiving high dose of upadacitinib
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Name: ABT-494

Experimental: Cohort 3
Study participants, 2 to <6 years of age, receiving low dose of upadacitinib
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Name: ABT-494

Experimental: Cohort 4
Study participants, 2 to <6 years of age, receiving high dose of upadacitinib
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Name: ABT-494




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 7 days ]
    It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.

  2. 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.

  3. Area under the plasma concentration-time curve within a dosing interval (AUC) [ Time Frame: Up to 7 days ]
    The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.

  4. Oral Clearance [ Time Frame: Up to 7 days ]
    Clearance is defined the volume of plasma cleared of the drug per unit time.


Secondary Outcome Measures :
  1. Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to 37 Days ]
    Number of participants with adverse events during treatment will be assessed.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with total body weight of 10 kg or higher at Baseline.
  • Participants diagnosed with active severe atopic dermatitis (AD) defined by Eczema Area Severity Index (EASI), Investigator's Global Assessment (IGA) and body surface area (BSA).
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646604


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
Beach Pediatrics /ID# 207834 Recruiting
Huntington Beach, California, United States, 92647-6818
Childrens Hospital LA /ID# 206042 Not yet recruiting
Los Angeles, California, United States, 90027
United States, Florida
Pediatric Skin Research, LLC /ID# 213468 Not yet recruiting
Coral Gables, Florida, United States, 33146-1837
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 206224 Not yet recruiting
Chicago, Illinois, United States, 60611-2927
United States, Missouri
Washington University of St. Louis /ID# 206972 Not yet recruiting
Saint Louis, Missouri, United States, 63141-6399
United States, New Mexico
University of New Mexico School of Medicine /ID# 206757 Not yet recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, Ohio
Cincinnati Children's Hospital /ID# 207071 Not yet recruiting
Cincinnati, Ohio, United States, 45229-3026
United States, Oregon
Oregon Health and Science University (OHSU) /ID# 206226 Not yet recruiting
Portland, Oregon, United States, 97239-4501
United States, Pennsylvania
Penn State University and Milton S. Hershey Medical Center /ID# 207096 Not yet recruiting
Hershey, Pennsylvania, United States, 17033-2360
Paddington Testing Co., Inc. /ID# 207079 Recruiting
Philadelphia, Pennsylvania, United States, 19103
United States, West Virginia
West Virginia University /ID# 206792 Not yet recruiting
Morgantown, West Virginia, United States, 26506
Ireland
Our Lady's Children's Hospital /ID# 211199 Not yet recruiting
Dublin, Ireland, Dublin 12
Netherlands
Universitair Medisch Centrum Utrecht /ID# 210140 Not yet recruiting
Utrecht, Netherlands, 3584 CX
Norway
Haukeland University Hospital /ID# 210162 Not yet recruiting
Bergen, Hordaland, Norway, 5021
Rikshospitalet OUS HF /ID# 210163 Not yet recruiting
Oslo, Norway, 0450
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03646604     History of Changes
Other Study ID Numbers: M16-049
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by AbbVie:
Upadacitinib
ABT-494
Atopic Dermatitis

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents