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Trial record 40 of 159 for:    Recruiting, Not yet recruiting, Available Studies | "Eczema"

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 : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
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

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
Estimated Study Start Date : August 23, 2018
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : October 15, 2022

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 as the volume of plasma cleared of the drug per unit time.

  5. 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 12 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
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

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: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases