A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03101670
• Date of registration: 30/03/2017
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• Public title: A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis EQUATOR
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis
• Date of first enrolment: March 9, 2017
• Target sample size: 131
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03101670
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Bulgaria, Czechia, Estonia, Poland, Spain, Ukraine

Contacts

• Name: Pille Harrison, MD, DPhil, MRCP (UK)
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Male or female subjects who are =18 years of age, on the day of signing informed
consent.

- Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic
Arthritis (CASPAR)

- Have active psoriatic arthritis defined as =5 swollen joints (from a 66 swollen joint
count [SJC]) and =5 tender joints (from a 68 tender joint count [TJC]) at Screening
and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if
tender, then also a single tender joint).

- Have had a history of documented plaque psoriasis or currently active plaque psoriasis

- If using cDMARD therapy, subjects must have been on it for 12 weeks prior to
screening, with a stable dose (including stable route of administration) for at least
4 weeks prior to baseline.

- If using non-drug therapies (including physical therapies), thse should be kept sable
during screening

- 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

Key Exclusion Criteria:

- Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;

- Prior use of more than one TNF inhibitor, at any time.

- 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 cyclooxygenase-2 (COX-2) inhibitor.

- Have undergone surgical treatment for psoriatic arthritis including synovectomy and
arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening

- Presence of very poor functional status or unable to perform self-care.

- Administration of a live or attenuated vaccine within 12 weeks prior to baseline



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: Placebo Oral Tablet

Drug: filgotinib

Primary Outcome(s)

Percentage of subjects who have reached ACR20 response as compared to placebo [Time Frame: Week 16]

Secondary Outcome(s)

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment [Time Frame: From screening until the final follow up visit (week 20)]

Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG [Time Frame: From screening until the final follow up visit (week 20)]

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination [Time Frame: From screening until the final follow up visit (week 20)]

Percentage of subjects achieving SDAI response as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events [Time Frame: From screening until the final follow up visit (week 20)]

Assessment of CRP in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Percentage of subjects achieving CDAI response as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Percentage of subjects who have reached ACR50 response as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of physician's and patient's global assessment of disease activity as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations [Time Frame: From screening until the final follow up visit (week 20)]

Assessment of mNAPSI in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs [Time Frame: From screening until the final follow up visit (week 20)]

Percentage of subjects who have reached ACR70 response as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Assessment of SF-36 in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Percentage of subjects achieving DAS28(CRP) score as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Percentage of subjects achieving EULAR response as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo [Time Frame: At each visit from screening until the final follow up visit (week 20)]

Secondary ID(s)

GLPG0634-CL-224

Source(s) of Monetary Support

Please refer to primary and secondary sponsors