A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2016-003636-21-EE
• Date of registration: 08/12/2016
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitis
• Scientific title: A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis
• Date of first enrolment: 26/01/2017
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003636-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• 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 on the day of signing informed consent.
• Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria (see protocol) for ankylosing spondylitis at screening, having radiographic sacroiliitis confirmed by central reading (historical radiographs up to 12 months are considered appropriate).
• Have active ankylosing spondylitis with a BASDAI =4 (numeric rating scale [NRS] 0-10) and spinal pain =4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
• Screening serum high-sensitivity CRP (hsCRP) =0.3 mg/dL.
• Have had a documented inadequate response to 2 or more NSAIDs including cyclooxygenase-2 (COX-2) inhibitors at the therapeutic dose range for a total duration of at least 4 weeks (less than 4 weeks permitted in cases of documented intolerance).
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
• Prior use of more than one TNF inhibitor (including proposed biosimilars with demonstrated equivalence to an approved TNF inhibitor for efficacy in a clinical study), at any time. Prior use of one TNF inhibitor is allowed, with the following minimum washout periods prior to screening:
- Etanercept: 4 weeks
- Adalimumab, certolizumab pegol, golimumab: 8 weeks
- Infliximab: 12 weeks;
• Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
• Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
• Use of more than 1 NSAID or COX-2 inhibitor. If an NSAID or COX-2 inhibitor is used, it must not exceed maximum doses permitted, as per local labeling and must have been used at a stable dose for at least 2 weeks prior to baseline. In addition, subjects are permitted to take acetylsalicylic acid at a dose of =325 mg q.d. for cardiac prophylaxis;
• Contraindication to MRI.
• History of known or suspected complete ankylosis of the spine.
• Presence of very poor functional status or unable to perform self-care.
• Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
• Administration of a live or attenuated vaccine within 12 weeks prior to baseline.


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

Health Condition(s) or Problem(s) studied

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

ankylosing spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Evaluate the effect of filgotinib compared to placebo on:
- The signs and symptoms of ankylosing spondylitis
- Physical function
- Spinal mobility
- Spinal and sacroiliac joint inflammation
- Enthesitis
- Quality of life

Evaluate the safety and tolerability of filgotinib

Main Objective: Evaluate the effect of filgotinib compared to placebo on the signs and symptoms of ankylosing spondylitis, as assessed by the ASDAS at Week 12.

Primary end point(s): Change from baseline in the ASDAS at week 12

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): Efficacy:
• The signs and symptoms of ankylosing spondylitis, as assessed by:
- Change from baseline in the ASDAS
- Percentage of patients achieving ASAS20, ASAS40, ASAS 5/6 response and ASAS
partial remission
- Change from baseline in 44-joint count
- Proportions of subjects who experience clinically important improvement (decrease
of ASDAS from baseline =1.1), major improvement (decrease of ASDAS from
baseline =2.0), and inactive disease (ASDAS <1.3)
- Change from baseline in the individual components of the ASAS response criteria
and the ASDAS
- Percentage of patients achieving BASDAI 50% response (BASDAI50) and =2 units
improvement in BASDAI (?BASDAI=2)
- Change from baseline in BASDAI
• Physical function, as assessed by change from baseline in BASFI
• Spinal mobility, as assessed by change from baseline in BASMI linear and in the individual components of the BASMI criteria, chest expansion and occiput-to-wall distance.
• Spinal and sacroiliac joint inflammation as assessed by change from baseline in SPARCC MRI score of sacroiliac joints and spine.
• Enthesitis, as assessed by change from baseline in MASES.
• Quality of life, as assessed by change from baseline in FACIT-Fatigue, SF-36, and ASQoL scores.

Safety:
Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, physical examination and vital signs.

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

Secondary ID(s)

GLPG0634-CL-223

Source(s) of Monetary Support

Galapagos NV

Ethics review

Status: Approved
Approval date: 26/01/2017
Contact:

Results

• Results available: Yes
• Date Posted: 24/04/2019
• Date Completed: 02/07/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003636-21/results