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

AbbVie

Status and phase: Active, not recruiting; 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: 32 estimated 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)

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32 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)