Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| filgotinib | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgotinib | Drug | one filgotinib oral tablet q.d. |
| |
| Placebo Oral Tablet |
| 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 |
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pille Harrison, MD, DPhil, MRCP (UK) | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB Hopital Erasme, Service de Rheumatology | Brussels | Belgium | ||||
| UMHAT "Kaspela", EOOD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37945284 | Derived | Chandran V, Malkov VA, Ito KL, Liu Y, Vestergaard L, Yoon OK, Liu J, Trivedi M, Hertz A, Gladman D. Pharmacodynamic effects of filgotinib treatment driving clinical improvement in patients with active psoriatic arthritis enrolled in the EQUATOR trial. RMD Open. 2023 Nov;9(4):e003550. doi: 10.1136/rmdopen-2023-003550. | |
| 31624837 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
one placebo oral tablet q.d. |
|
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) |
| Plovdiv |
| Bulgaria |
| MHAT - Ruse, AD | Rousse | Bulgaria |
| UMHAT "SofiaMed", OOD, Block 1 | Sofia | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria |
| CCBR Czech, a.s | Pardubice | Czechia |
| MEDICAL PLUS s.r.o. | Uherské Hradiště | Czechia |
| Center for Clinical and Basic Research | Tallinn | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | Estonia |
| OÜ Innomedica | Tallinn | Estonia |
| Twoja Przychodnia-Centrum Medyczne Nowa Sol | Nowa Sól | Poland |
| Ai Centrum Medyczne sp. z o.o. sp.k. | Poznan | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna | Torun | Poland |
| Centrum Medyczne AMED, Warszawa Targowek | Warsaw | Poland |
| Hospital Universitario de Fuenlabrada, Servicio de Reumatologia | Fuenlabrada | Spain |
| Hospital Infanta Luisa, Servicio de Reumatologia | Seville | Spain |
| 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 | Lviv | 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 | Vinnytsia | Ukraine |
| MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology | Vinnytsia | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy | Vinnytsia | Ukraine |
| Orbai AM, Ogdie A, Gossec L, Tillett W, Leung YY, Gao J, Trivedi M, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Coates LC. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology (Oxford). 2020 Jul 1;59(7):1495-1504. doi: 10.1093/rheumatology/kez408. |
| 30360969 | Derived | Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. Epub 2018 Oct 22. |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
Not provided
Not provided
Not provided