Dermatology Research News 
PurposeThis 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).
| Condition | Intervention | Phase |
|---|---|---|
| Psoriatic Arthritis | Drug: filgotinib Drug: Placebo Oral Tablet | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics: psoriatic arthritis
Further study details as provided by Galapagos NV:
Primary Outcome Measures:
- Percentage of subjects who have reached ACR20 response as compared to placebo [ Time Frame: Week 16 ]To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
Secondary Outcome Measures:
- 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) ]To assess the effect of filogotinib on MDA in PsA patients
- 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) ]To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients
- 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) ]To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients
- 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) ]To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients
- 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) ]To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients
- 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) ]To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients
- 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) ]To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients
- 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) ]To assess the effect of filogotinib on PsARC in PsA patients
- 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) ]To assess the effect of filogotinib on physician’s and patient’s global assessment of disease activity in PsA patients
- 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) ]To assess the effect of filogotinib on on PsA pain intensity in PsA patients
- 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) ]To assess the effect of filgotinib on joint tenderness and swelling in PsA patients
- 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) ]To assess the effect of filogotinib on CRP in PsA patients
- 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) ]To assess the effect of filgotinib on PASI in PsA patients
- 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) ]To assess the effect of filgotinib on PASI50 in PsA patients
- 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) ]To assess the affect of filgotinib on PASI75 in PsA patients
- 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) ]To assess the affect of filgotinib on PASI90 in PsA patients
- 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) ]To assess the affect of filgotinib on PASI100 in PsA patients
- 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) ]To assess the affect of filgotinib on Physician’s and patient’s global assessment of psoriasis in PsA patients
- 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) ]To assess the effect of filgotinib on mNAPSI in PsA patients
- 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) ]To assess the effect of filgotinib on NRS in PsA patients
- 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) ]To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients
- 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) ]To assess the effect of filgotinib on Dactilytis in PsA patients
- 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) ]To assess the effect of filgotinib on physical function in PsA patients
- 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) ]To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients
- 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) ]To assess the effect of filgotinib on SF-36 in PsA patients
- 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) ]To assess the effect of filgotinib on PsAID in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
- 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) ]To evaluation safety and tolerability of filgotinib in PsA patients
| Estimated Enrollment: | 124 |
| Actual Study Start Date: | March 9, 2017 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: filgotinib | Drug: filgotinib one filgotinib oral tablet q.d. |
| Placebo Comparator: placebo | Drug: Placebo Oral Tablet one placebo oral tablet q.d. |
