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Trial record 3 of 38 for:    upadacitinib

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT03725007
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of two parts: Part 1 is multiple-cohort study that consists of two sequential multiple-ascending dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis (JIA) Drug: Upadacitinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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 Polyarticular Course Juvenile Idiopathic Arthritis
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 10, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants of age group 12 to <18 years receiving dose A
Participants of age group 12 to <18 years administered with upadacitinib dose A(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494

Experimental: Participants of age group 12 to <18 years receiving dose B
Participants of age group 12 to <18 years administered with upadacitinib dose B(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494

Experimental: Participants of age group 6 to <12 years receiving dose A
Participants of age group 6 to <12 years administered with upadacitinib dose A(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494

Experimental: Participants of age group 6 to <12 years receiving dose B
Participants of age group 6 to <12 years administered with upadacitinib dose B(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494

Experimental: Participants of age group 2 to <6 years receiving dose A
Participants of age group 2 to <6 years administered with upadacitinib dose A(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494

Experimental: Participants of age group 2 to <6 years receiving dose B
Participants of age group 2 to <6 years administered with upadacitinib dose B(weight dependent) as described in the protocol
Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 7 ]
    Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Day 7 ]
    Cmax is defined as the maximum observed plasma concentration for upadacitinib.

  3. Time to maximum observed plasma concentration (Tmax) [ Time Frame: Day 7 ]
    Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.

  4. Area under plasma concentration versus time curve during a dosing interval (AUCtau) [ Time Frame: Day 7 ]
    The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.

  5. Apparent oral clearance at steady state (CL/F) [ Time Frame: Day 7 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.

  6. Half-life [ Time Frame: Day 7 ]
    Half life of updadacitinib will be determined using non-compartmental method.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant have total body weight of 10 kg or higher at the time of screening.
  • Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints during the first 6 months of disease (for extended oligoarticular JIA: <=4 joints during first 6 months of disease and >4 joints thereafter).
  • Participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (LOM) plus pain on motion and/or tenderness with palpitation, with LOM present in at least three of the active joints.
  • If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on an stable dose of 10 to 20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
  • If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1.

Exclusion Criteria:

  • Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
  • Participant have prior exposure to JAK inhibitor.

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): NCT03725007


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 211162 Not yet recruiting
Chicago, Illinois, United States, 60611-2991
United States, Kentucky
University of Louisville /ID# 202896 Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston Childrens Hospital /ID# 202993 Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Ohio
Cincinnati Childrens Hosp Med /ID# 209697 Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Randall Children's Hospital /ID# 213609 Not yet recruiting
Portland, Oregon, United States, 97227-1654
United States, Pennsylvania
Children's Hospital of Philadelphia /ID# 209617 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19146-2305
Children's Hospital of Pittsburgh of UPMC /ID# 202994 Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1334
United States, Washington
Seattle Children's Hospital /ID# 203003 Recruiting
Seattle, Washington, United States, 98105
Germany
PRI - Pediatric Rheumatology Research Institute /ID# 205954 Recruiting
Bad Bramstedt, Germany, 24576
Helios Klinikum Berlin Buch /ID# 206859 Recruiting
Berlin, Germany, 13125
Kinder- & Jugendrheumatologie /ID# 206571 Recruiting
Hamburg, Germany, 22081
Asklepios Klinik St. Augustin /ID# 203264 Recruiting
Sankt Augustin, Germany, 53757
Hungary
Semmelweis Egyetem II. Számú Gyermekgyógyászati Klinika /ID# 208970 Not yet recruiting
Budapest VIII, Pest, Hungary, 1082
Italy
IRCCS Ospedale Pediatrico Bambino Gesù /ID# 203835 Not yet recruiting
Rome, Lazio, Italy, 00165
Azienda Ospedaliero Universitaria Meyer /ID# 215576 Not yet recruiting
Florence, Italy, 50139
IRCCS Istituto G. Gaslini /ID# 203648 Not yet recruiting
Genoa, Italy, 16147
Puerto Rico
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406 Completed
Bayamon, Puerto Rico, 00959
GCM Medical Group PSC - Hato Rey /ID# 211702 Not yet recruiting
San Juan, Puerto Rico, 00917-3104
Mindful Medical Research /ID# 204488 Completed
San Juan, Puerto Rico, 00918-3756
Spain
Hospital Sant Joan de Deu /ID# 203915 Recruiting
Esplugues de Llobregat, Spain, 08950
Hosp Infantil Univ Nino Jesus /ID# 206466 Recruiting
Madrid, Spain, 28009
Hospital Univ Ramon y Cajal /ID# 203917 Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz /ID# 203927 Recruiting
Madrid, Spain, 28046
Hospital Universitario La Fe /ID# 203914 Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03725007     History of Changes
Other Study ID Numbers: M15-340
2018-000715-25 ( EudraCT Number )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Upadacitinib
ABT-494
Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
Additional relevant MeSH terms:
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Upadacitinib
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents