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

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AbbVie

Status and phase

Completed
Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: Upadacitinib (ABT-494)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03646604
M16-049
2018-004409-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

35 participants in 5 patient groups

Part 1; Cohort 1
Experimental group
Description:
Participants, 6 to \<12 years of age, will receive low dose of upadacitinib.
Treatment:
Drug: Upadacitinib (ABT-494)
Part 1; Cohort 2
Experimental group
Description:
Participants, 6 to \<12 years of age, will receive high dose of upadacitinib.
Treatment:
Drug: Upadacitinib (ABT-494)
Part 1; Cohort 3
Experimental group
Description:
Participants, 2 to \<6 years of age, will receive low dose of upadacitinib.
Treatment:
Drug: Upadacitinib (ABT-494)
Part 1; Cohort 4
Experimental group
Description:
Participants, 2 to \<6 years of age, will receive high dose of upadacitinib.
Treatment:
Drug: Upadacitinib (ABT-494)
Part 2
Experimental group
Description:
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Treatment:
Drug: Upadacitinib (ABT-494)

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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