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

Study Overview
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Brief Summary
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This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).

Official Title
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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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: filgotinib
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: filgotinib<br> | Drug: filgotinib<br>* one filgotinib oral tablet q.d.<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo Oral Tablet<br>* one placebo oral tablet q.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who have reached ACR20 response as compared to placebo | To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo | To assess the effect of filogotinib on MDA in PsA patients | 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 | To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Percentage of subjects who have reached ACR70 response as compared to placebo | To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Percentage of subjects achieving DAS28(CRP) score as compared to placebo | To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Percentage of subjects achieving SDAI response as compared to placebo | To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Percentage of subjects achieving CDAI response as compared to placebo | To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Percentage of subjects achieving EULAR response as compared to placebo | To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo | To assess the effect of filogotinib on PsARC in PsA patients | 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 | To assess the effect of filogotinib on physician's and patient's global assessment of disease activity in PsA patients | 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 | To assess the effect of filogotinib on on PsA pain intensity in PsA patients | 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 | To assess the effect of filgotinib on joint tenderness and swelling in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Assessment of CRP in filgotinib treated subjects as compared to placebo | To assess the effect of filogotinib on CRP in PsA patients | 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 | To assess the effect of filgotinib on PASI in PsA patients | 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 | To assess the effect of filgotinib on PASI50 in PsA patients | 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 | To assess the affect of filgotinib on PASI75 in PsA patients | 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 | To assess the affect of filgotinib on PASI90 in PsA patients | 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 | To assess the affect of filgotinib on PASI100 in PsA patients | At each visit 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 | To assess the affect of filgotinib on Physician's and patient's global assessment of psoriasis in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| Assessment of mNAPSI in filgotinib treated subjects as compared to placebo | To assess the effect of filgotinib on mNAPSI in PsA patients | 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 | To assess the effect of filgotinib on NRS in PsA patients | 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 | To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients | 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 | To assess the effect of filgotinib on Dactilytis in PsA patients | 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 | To assess the effect of filgotinib on physical function in PsA patients | At each visit from screening until the final follow up visit (week 20) | 
| FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo | To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients | 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 | To assess the effect of filgotinib on SF-36 in PsA patients | 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 | To assess the effect of filgotinib on PsAID in PsA patients | 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 | To evaluation safety and tolerability of filgotinib in PsA patients | 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 | To evaluation safety and tolerability of filgotinib in PsA patients | 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 | To evaluation safety and tolerability of filgotinib in PsA patients | 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 | To evaluation safety and tolerability of filgotinib in PsA patients | From screening until the final follow up visit (week 20) | 
| Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG | To evaluation safety and tolerability of filgotinib in PsA patients | From screening until the final follow up visit (week 20) | 
| Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment | To evaluation safety and tolerability of filgotinib in PsA patients | From screening until the final follow up visit (week 20) |