Long-term open-label study of filgotinib in subjects with psoriatic arthritis

• Register: EUCTR
• Last refreshed on: 17 August 2021
• Main ID: EUCTR2017-000545-52-CZ
• Date of registration: 16/06/2017
• Prospective Registration: Yes
• Primary sponsor: Galapagos Nv
• Public title: Long-term open-label study of filgotinib in subjects with psoriatic arthritis
• Scientific title: A multicenter, open-label, long-term extension safety and efficacy study of filgotinib treatment in subjects with moderately to severely active psoriatic arthritis
• Date of first enrolment: 02/08/2017
• Target sample size: 105
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000545-52
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Estonia, Germany, Poland, Spain, Ukraine

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Galapagos NV

• Name: Clinical Trial Information Desk
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female subjects who are =18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator’s judgment.
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
• Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
• Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator’s clinical judgment.
• Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
• Subjects who require immunization with live/live attenuated vaccine.
• Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren’s syndrome.
• Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.

Reference is made to the protocol for a complete overview of the exclusion criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic arthritis
MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Filgotinib
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: - To evaluate the long-term efficacy of filgotinib in patients with PsA.
- To evaluate the long-term effects of filgotinib administration on disability, fatigue and quality of life in patients with PsA.

Timepoint(s) of evaluation of this end point: Various timepoints throughout the trial as specified in the protocol

Primary end point(s): Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, body weight and vital signs over time

Main Objective: To evaluate the long-term safety and tolerability of filgotinib in patients with psoriatic arthritis (PsA).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At each on-site visit unless otherwise specified in the protocol

Secondary end point(s): • Signs and symptoms of PsA:
- Proportion of subjects achieving MDA.
- Proportion of subjects with PASDAS low disease activity (LDA, i.e.
PASDAS = 3.2) and proportion of subjects with PASDAS VLDA (Very Low
Disease Activity, i.e. PASDAS = 1.9).
• Signs and symptoms of peripheral arthritis:
- Proportion of subjects achieving ACR20, ACR50 and ACR70 response
rates.
- Percentage of patients with Psoriatic Arthritis Disease Activity Score
(PASDAS) low disease activity (LDA, i.e. PASDAS =3.2)
- Percentage of patients with PASDAS VLDA (Very Low Disease Activity,
i.e. PASDAS=1.9)
- Change from core baseline in Disease Activity Index for Psoriatic
Arthritis (DAPSA)
- Proportion of subjects with DAPSA remission/LDA (DAPSA = 14) and
proportion of subjects with DAPSA remission (DAPSA = 4)
• Psoriasis in those subjects with psoriasis involving =3% Body Surface
Area (BSA), or with psoriatic nail involvement (only for mNAPSI), at core
baseline:
- Change from core baseline in PASI and proportions of subjects with
PASI50, PASI75, PASI90, and PASI100.
- Change from core baseline in Physician's Global Assessment of
psoriasis.
- Change from core baseline in Patient's Global Assessment of psoriasis.
- Change from core baseline in mNAPSI.
- Change from core baseline in pruritus NRS.
- Proportion of subjects achieving a pruritus NRS response
(improvement in pruritus NRS score of =3).
• Enthesitis in those subjects with enthesitis at core baseline:
- Change from core baseline in the SPARCC Enthesitis Index.
• Dactylitis in those subjects with dactylitis at core baseline:
- Change from core baseline in LDI.
• Physical function:
- Change from core baseline in HAQ-DI.
• Fatigue and general quality of life:
- Change from core baseline in FACIT-Fatigue, SF-36, and PsAID scores.
• Signs and symptoms of peripheral arthritis and physical function:
- Change from core baseline in individual components of the ACR
response criteria

Secondary ID(s)

GLPG0634-CL-225

2017-000545-52-BE

Source(s) of Monetary Support

Galapagos NV

Ethics review

Status: Approved
Approval date: 07/06/2017
Contact: