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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646604
Recruitment Status : Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

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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 : September 23, 2024
Estimated Study Completion Date : September 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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


Locations
Show Show 18 study locations
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: August 2, 2022
Last Verified: August 2022
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