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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

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).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: filgotinib Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
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
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: filgotinib Drug: filgotinib
one filgotinib oral tablet q.d.

Placebo Comparator: placebo Drug: Placebo Oral Tablet
one placebo oral tablet q.d.




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  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) ]
    To assess the effect of filgotinib on NRS in PsA patients

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101670


Locations
Belgium
ULB Hopital Erasme, Service de Rheumatology
Brussels, Belgium
Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, Bulgaria
MHAT - Ruse, AD
Ruse, Bulgaria
UMHAT "SofiaMed", OOD, Block 1
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria
Czechia
CCBR Czech, a.s
Pardubice, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia
Estonia
Center for Clinical and Basic Research
Tallinn, Estonia
North Estonia Medical Centre Foundation
Tallinn, Estonia
OÜ Innomedica
Tallinn, Estonia
Poland
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól, Poland
Ai Centrum Medyczne sp. z o.o. sp.k.
Poznań, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Toruń, Poland
Centrum Medyczne AMED, Warszawa Targowek
Warsaw, Poland
Spain
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Fuenlabrada, Spain
Hospital Infanta Luisa, Servicio de Reumatologia
Sevilla, Spain
Ukraine
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
Kharkiv, Ukraine
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
Kiev, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
Kiev, Ukraine
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
L'viv, Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
Poltava, Ukraine
CI of TRC
Ternopil', Ukraine
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
Vinnytsya, Ukraine
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Vinnytsya, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Vinnytsya, Ukraine
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Pille Harrison, MD, DPhil, MRCP (UK) Galapagos NV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03101670     History of Changes
Other Study ID Numbers: GLPG0634-CL-224
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases