Atopic DermatitisPhase 1NCT03646604
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
A Phase 1 study testing Upadacitinib (ABT-494) in people with Atopic Dermatitis, run by AbbVie at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Upadacitinib (ABT-494)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 31 Jan 2019to 29 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
University of New Mexico School of Medicine /ID# 206757
Albuquerque, New Mexico, 87131-0001
Arlington Research Center, Inc /ID# 222901
Arlington, Texas, 76011
Northwestern University Feinberg School of Medicine /ID# 206224
Chicago, Illinois, 60611-2927
Cincinnati Children's Hospital /ID# 207071
Cincinnati, Ohio, 45229
IACT Health-Columbus /ID# 216370
Columbus, Georgia, 31904-8946
Pediatric Skin Research, LLC /ID# 213468
Coral Gables, Florida, 33146-1837
Rybear, Inc /ID# 231801
Fort Lauderdale, Florida, 33316-1952
Penn State University and Milton S. Hershey Medical Center /ID# 207096
Hershey, Pennsylvania, 17033-2360
Beach Pediatrics /ID# 207834
Huntington Beach, California, 92647-6818
Dawes Fretzin, LLC /ID# 214958
Indianapolis, Indiana, 46256
Children's Hospital Los Angeles /ID# 206042
Los Angeles, California, 90027
West Virginia University Hospitals /ID# 206792
Morgantown, West Virginia, 26506
Paddington Testing Co., Inc. /ID# 207079
Philadelphia, Pennsylvania, 19103
Oregon Medical Research Center /ID# 206226
Portland, Oregon, 97239
Duplicate_Washington University of St. Louis /ID# 206972
St Louis, Missouri, 63141-6399
Norway2 sites
Haukeland University Hospital /ID# 210162
Bergen, Hordaland, 5021
Rikshospitalet OUS HF /ID# 210163
Oslo, 0450
Puerto Rico1 site
Alma M. Cruz Santana, MD-Private practice /ID# 214890
Carolina, 00985
About this study
Official title: An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
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
- Being tested
- Upadacitinib (ABT-494)
- Keywords
- Upadacitinib, ABT-494, Atopic Dermatitis, RINVOQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib (ABT-494)Drug
Also called ABT-494, RINVOQ
Upadacitinib will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1; Cohort 1 | Experimental | Participants, 6 to <12 years of age, will receive low dose of upadacitinib. Receives: Drug: Upadacitinib (ABT-494) |
| Part 1; Cohort 2 | Experimental | Participants, 6 to <12 years of age, will receive high dose of upadacitinib. Receives: Drug: Upadacitinib (ABT-494) |
| Part 1; Cohort 3 | Experimental | Participants, 2 to <6 years of age, will receive low dose of upadacitinib. Receives: Drug: Upadacitinib (ABT-494) |
| Part 1; Cohort 4 | Experimental | Participants, 2 to <6 years of age, will receive high dose of upadacitinib. Receives: Drug: Upadacitinib (ABT-494) |
| Part 2 | Experimental | Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib. Receives: Drug: Upadacitinib (ABT-494) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Measured: Up to 7 days
Time to Maximum Observed Plasma Concentration (Tmax)
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Measured: 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.
Measured: Up to 7 days
Oral Clearance
Clearance is defined the volume of plasma cleared of the drug per unit time.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start31 Jan 2019
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646604
- Sponsor's protocol ID
- M16-049
- Other IDs
- 2018-004409-17, 2018
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2018
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39142926
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03646604
- Acronym / sponsor ID
- M16-049
- Conditions
- Atopic Dermatitis
- Keywords
- Upadacitinib, ABT-494, Atopic Dermatitis, RINVOQ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1; Cohort 1 | Experimental | Drug: Upadacitinib (ABT-494)Participants, 6 to <12 years of age, will receive low dose of upadacitinib. |
| Part 1; Cohort 2 | Experimental | Drug: Upadacitinib (ABT-494)Participants, 6 to <12 years of age, will receive high dose of upadacitinib. |
| Part 1; Cohort 3 | Experimental | Drug: Upadacitinib (ABT-494)Participants, 2 to <6 years of age, will receive low dose of upadacitinib. |
| Part 1; Cohort 4 | Experimental | Drug: Upadacitinib (ABT-494)Participants, 2 to <6 years of age, will receive high dose of upadacitinib. |
| Part 2 | Experimental | Drug: Upadacitinib (ABT-494)Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib (ABT-494)Also: ABT-494, RINVOQUpadacitinib will be administered orally. | Drug | Part 1; Cohort 1, Part 1; Cohort 2, Part 1; Cohort 3, Part 1; Cohort 4, Part 2 |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Up to 7 days
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
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.
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.
Oral Clearance
Time frame: Up to 7 days
Clearance is defined the volume of plasma cleared of the drug per unit time.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 39142926Qian 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.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingObservational study
Observational Analytical Validation Study of the Replior ScratchSense
Atopic Dermatitis, Other Pruritic Dermatological
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingObservational study
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Atopic Dermatitis
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Upadacitinib (ABT-494) in people with Atopic Dermatitis, run by AbbVie at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Norway, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.