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

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ClinicalTrials.gov Identifier: NCT03101670
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 5, 2017
Last Update Posted Date April 23, 2018
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: filgotinib
    one filgotinib oral tablet q.d.
  • Drug: Placebo Oral Tablet
    one placebo oral tablet q.d.
Study Arms  ICMJE
  • Experimental: filgotinib
    Intervention: Drug: filgotinib
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo Oral Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2018)
131
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2017)
124
Actual Study Completion Date  ICMJE March 12, 2018
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   Estonia,   Poland,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101670
Other Study ID Numbers  ICMJE GLPG0634-CL-224
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pille Harrison, MD, DPhil, MRCP (UK) Galapagos NV
PRS Account Galapagos NV
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP