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

NCT03646604 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: M16-0492018-004409-17
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 18

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.

Conditions

Atopic Dermatitis

Keywords

Upadacitinib; ABT-494; Atopic Dermatitis; RINVOQ

Outcome Measures

Primary Outcomes (5)

• Maximum Plasma Concentration (Cmax)

  It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.

  Up to 7 days

• Time to Maximum Observed Plasma Concentration (Tmax)

  It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.

  Up to 7 days

• Area under the plasma concentration-time curve within a dosing interval (AUCtau)

  The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.

  Up to 7 days

• Oral Clearance

  Clearance is defined the volume of plasma cleared of the drug per unit time.

  Up to 7 days

• Number of Participants With Treatment Emergent Adverse Events (TEAE)

  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.

  Up to 2 years

Study Arms (5)

Part 1; Cohort 1

EXPERIMENTAL

Participants, 6 to \<12 years of age, will receive low dose of upadacitinib.

Drug: Upadacitinib (ABT-494)

Part 1; Cohort 2

EXPERIMENTAL

Participants, 6 to \<12 years of age, will receive high dose of upadacitinib.

Drug: Upadacitinib (ABT-494)

Part 1; Cohort 3

EXPERIMENTAL

Participants, 2 to \<6 years of age, will receive low dose of upadacitinib.

Drug: Upadacitinib (ABT-494)

Part 1; Cohort 4

EXPERIMENTAL

Participants, 2 to \<6 years of age, will receive high dose of upadacitinib.

Drug: Upadacitinib (ABT-494)

Part 2

EXPERIMENTAL

Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.

Drug: Upadacitinib (ABT-494)

Interventions

Upadacitinib (ABT-494) DRUG

Upadacitinib will be administered orally.

Also known as: ABT-494, RINVOQ

Part 1; Cohort 1; Part 1; Cohort 2; Part 1; Cohort 3; Part 1; Cohort 4; Part 2

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (18)

Beach Pediatrics /ID# 207834

Huntington Beach, California, 92647-6818, United States

Location

Children's Hospital Los Angeles /ID# 206042

Los Angeles, California, 90027, United States

Location

Pediatric Skin Research, LLC /ID# 213468

Coral Gables, Florida, 33146-1837, United States

Location

Rybear, Inc /ID# 231801

Fort Lauderdale, Florida, 33316-1952, United States

Location

IACT Health-Columbus /ID# 216370

Columbus, Georgia, 31904-8946, United States

Location

Northwestern University Feinberg School of Medicine /ID# 206224

Chicago, Illinois, 60611-2927, United States

Location

Dawes Fretzin, LLC /ID# 214958

Indianapolis, Indiana, 46256, United States

Location

Duplicate_Washington University of St. Louis /ID# 206972

St Louis, Missouri, 63141-6399, United States

Location

University of New Mexico School of Medicine /ID# 206757

Albuquerque, New Mexico, 87131-0001, United States

Location

Cincinnati Children's Hospital /ID# 207071

Cincinnati, Ohio, 45229, United States

Location

Oregon Medical Research Center /ID# 206226

Portland, Oregon, 97239, United States

Location

Penn State University and Milton S. Hershey Medical Center /ID# 207096

Hershey, Pennsylvania, 17033-2360, United States

Location

Paddington Testing Co., Inc. /ID# 207079

Philadelphia, Pennsylvania, 19103, United States

Location

Arlington Research Center, Inc /ID# 222901

Arlington, Texas, 76011, United States

Location

West Virginia University Hospitals /ID# 206792

Morgantown, West Virginia, 26506, United States

Location

Haukeland University Hospital /ID# 210162

Bergen, Hordaland, 5021, Norway

Location

Rikshospitalet OUS HF /ID# 210163

Oslo, 0450, Norway

Location

Alma M. Cruz Santana, MD-Private practice /ID# 214890

Carolina, 00985, Puerto Rico

Location

Related Publications (1)

• Qian Y, Raymundo EM, Hao S, Unnebrink K, Levy GF, Teixeira HD, Chu AD, Zinn ZA, Paller AS, Liu W, Mohamed MF. Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Upadacitinib in Children with Severe Atopic Dermatitis. Clin Ther. 2024 Oct;46(10):733-741. doi: 10.1016/j.clinthera.2024.07.003. Epub 2024 Aug 13.

  PMID: 39142926 DERIVED

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: January 31, 2019
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); NO (2); PR (1)