Evaluation of the Pharmacokinetics and Safety of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

19 Jun 2019 → ongoing

Decision date (initial)

2023-08-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Abbvie Inc

External identifiers

EU CT number

2023-505060-11-00

EudraCT number

2018-000715-25

ClinicalTrials.gov

NCT03725007

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

To evaluate the pharmacokinetics, safety, and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA.
To evaluate the long-term safety and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA who completed part 1. To evaluate the long-term safety and tolerability of upadacitinib in pediatric subjects with pcJIA.
To evaluate descriptive efficacy of upadaciinib in pcJIA.

Secondary objectives 1

1. To evaluate the palatability of upadacitinib oral solution in pediatric subjects.

Conditions and MedDRA coding

Polyarticular Course Juvenile Idiopathic Arthritis

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-627654-PIP05-10

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Individuals, ages 2 to less than 18 years, and total body weight of 10 kg or higher at the time of Screening.
2. 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 arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: ≤ 4 joints within the first 6 months of disease and > 4 joints thereafter).
3. Subject must not have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
4. 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 limitation of movement (LOM) plus pain on motion and/or tenderness with palpation, with LOM present in at least three of the active joints.
5. If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of ≤ 20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, subjects should take either folic acid or folinic acid according to local standard of care
6. If on oral glucocorticoids, must have been taking oral glucocorticoids 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.
7. No prior exposure to JAK inhibitor.

Exclusion criteria 2

1. Subject must have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
2. Prior exposure to JAK inhibitor.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.

Secondary endpoints 1

1. To evaluate the palatability of upadacitinib oral solution in pediatric subjects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 1

Locations

5 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

6 submissions — initial application plus substantial / non-substantial modifications