Open-label extension study with filgotinib in children with juvenile idiopathic arthritis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alfasigma S.p.A.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

13 Apr 2026 → ongoing

Decision date (initial)

2026-04-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Alfasigma S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

To determine the long-term safety and tolerability of filgotinib in children and adolescents who completed the parent studies of filgotinib in pJIA and sJIA.

Secondary objectives 3

1. To obtain information on the long-term efficacy of filgotinib in children and adolescents with pJIAsJIA.
2. To evaluate the effect of filgotinib on disease remission.
3. To assess the long-term effect of filgotinib on the incidence of uveitis.

Conditions and MedDRA coding

Juvenile idiopathic arthritis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001619-PIP04-17

Plan to share IPD

Yes

IPD plan description

Only after approval of the Marketing Authorization, at Alfasigma’s discretion.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Subject must have completed treatment with filgotinib in at least one parent study (GLPG0634-CL-131, GLPG0634-CL-329, or GLPG0634-CL-328) and achieved a clinical benefit at the end of the parent protocols.
2. Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/Institutional Review Board, prior to any protocol evaluations.
3. Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation) form.
4. Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the clinical study protocol.

Exclusion criteria 5

1. Development of any condition during the parent study that would preclude safe continuation.
2. Pregnancy.
3. Active infection that is clinically significant, as per Investigator’s judgment.
4. Subject with known hypersensitivity to the components of potential study therapy.
5. Subjects with any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.

Secondary endpoints 5

1. Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.
2. Percentage of subjects with JIA ACR inactive disease.
3. Percentage of subjects with JIA ACR clinical remission over time.
4. Incidence of treatment-emergent uveitis (including severity).
5. Duration of response.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alfasigma S.p.A.

Sponsor organisation

Alfasigma S.p.A.

Address

Via Ragazzi Del '99 5

City

Bologna

Postcode

40133

Country

Italy

Scientific contact point

Organisation

Alfasigma S.p.A.

Contact name

Medical Information

Public contact point

Organisation

Alfasigma S.p.A.

Contact name

Medical Information

Third parties 5

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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