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Trial record 1 of 1 for:    M16-049 | Atopic Dermatitis
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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646604
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : March 23, 2020
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 participants with severe atopic dermatitis.

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : November 28, 2024
Estimated Study Completion Date : November 28, 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 Names:
  • ABT-494
  • RINVOQ

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 Names:
  • ABT-494
  • RINVOQ

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 Names:
  • ABT-494
  • RINVOQ

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 Names:
  • ABT-494
  • RINVOQ

Experimental: Cohort 5
Study participants, 6 months to <2 years of age, receiving low dose of upadacitinib
Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
  • ABT-494
  • RINVOQ

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




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 (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.

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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with total body weight of 5 kilograms(kg) or higher at Baseline.
  • For Participants 2 to <12 years of age: 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.

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
Childrens Hospital LA /ID# 206042 Recruiting
Los Angeles, California, United States, 90027
United States, Florida
Pediatric Skin Research, LLC /ID# 213468 Recruiting
Coral Gables, Florida, United States, 33146-1837
United States, Georgia
IACT Health /ID# 216370 Not yet recruiting
Columbus, Georgia, United States, 31904-8946
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 206224 Recruiting
Chicago, Illinois, United States, 60611-2927
United States, Indiana
Dawes Fretzin, LLC /ID# 214958 Recruiting
Indianapolis, Indiana, United States, 46256
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 Recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, Ohio
Cincinnati Children's Hospital /ID# 207071 Recruiting
Cincinnati, Ohio, United States, 45229-3026
United States, Oregon
Oregon Health and Science University (OHSU) /ID# 206226 Recruiting
Portland, Oregon, United States, 97239-4501
United States, Pennsylvania
Penn State University and Milton S. Hershey Medical Center /ID# 207096 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 Recruiting
Morgantown, West Virginia, United States, 26506
Norway
Haukeland University Hospital /ID# 210162 Not yet recruiting
Bergen, Hordaland, Norway, 5021
Rikshospitalet OUS HF /ID# 210163 Not yet recruiting
Oslo, Norway, 0450
Puerto Rico
Cruz-Santana, Carolina, PR /ID# 214890 Recruiting
Carolina, Puerto Rico, 00985
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03646604    
Other Study ID Numbers: M16-049
2018-004409-17 ( EudraCT Number )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
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
RINVOQ
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
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