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

  Purpose

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).

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:

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.

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