A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03646604 |
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Recruitment Status :
Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : January 26, 2023
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
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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.
| 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 |
| Actual Study Start Date : | January 31, 2019 |
| Estimated Primary Completion Date : | August 23, 2024 |
| Estimated Study Completion Date : | August 23, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
Drug Information available for:
Upadacitinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1; Cohort 1
Participants, 6 to <12 years of age, will receive low dose of upadacitinib.
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Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
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Experimental: Part 1; Cohort 2
Participants, 6 to <12 years of age, will receive high dose of upadacitinib.
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Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
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Experimental: Part 1; Cohort 3
Participants, 2 to <6 years of age, will receive low dose of upadacitinib.
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Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
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Experimental: Part 1; Cohort 4
Participants, 2 to <6 years of age, will receive high dose of upadacitinib.
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Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
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Experimental: Part 2
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
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Drug: Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Other Names:
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Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
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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 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.
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
Locations
Show 18 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03646604 |
| Other Study ID Numbers: |
M16-049 2018-004409-17 ( EudraCT Number ) |
| First Posted: | August 24, 2018 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
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Upadacitinib ABT-494 Atopic Dermatitis RINVOQ |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Upadacitinib Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |