A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alfasigma S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

14 Sep 2017 → 16 May 2025

Decision date (initial)

2024-07-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Galapagos NV

External identifiers

EU CT number

2024-513919-27-00

EudraCT number

2016-003630-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA

Secondary objectives 2

1. To evaluate the long-term efficacy of filgotinib in subjects with RA
2. To evaluate the long-term effects of filgotinib on subject-reported outcomes, such as disability, fatigue, and quality of life

Conditions and MedDRA coding

Rheumatoid arthritis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Able and willing to sign the informed consent as approved by the IRB/IEC. Written consent must be provided before initiating any Day -1 evaluations for this study. Subjects must have read and understood the ICF, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
2. Male or female subjects who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: a) Subjects who completed GS-US-4170301, GS-US-417-0302, or GS-US-417-0303 on study drug OR b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status.
3. Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE.
4. Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study.
5. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception, during the study and through 35 days after their last dose of study drug or longer as indicated by the product label of the subject's concurrent csDMARD therapy.
6. Subjects receiving protocol permitted RA medications should be on a stable dose (defined as no change in prescription) within 7 days or 5 half lives (whichever is longer) prior to the first administration of LTE study drug on Day 1, as much as possible.
7. Subjects, who meet study drug interruption criteria at Day 1, are eligible to enter into the LTE, but should not start study drug until deemed medically appropriate as outlined in protocol section 3.5.1.

Exclusion criteria 9

1. Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator.
2. Known hypersensitivity to the study drug or its excipients.
3. Any medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator.
4. Administration of a live/ attenuated vaccine within 30 days prior to Day 1.
5. Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria).
6. History of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia).
7. Any condition or circumstances which in the opinion of the investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
8. Use of prohibited medication as outlined in the protocol.
9. Subjects who meet discontinuation criteria in outlined in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety, evaluated through AEs, clinical laboratory tests, and vital signs.

Secondary endpoints 1

1. ACR-N responses in each arm.

Investigational products

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

Test 2

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

Clinical Trials Information desk

Public contact point

Organisation

Alfasigma S.p.A.

Contact name

Clinical Trials Information desk

Third parties 5

Locations

3 EU/EEA countries · 16 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 24 files

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

Application history

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