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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03101670

Acronym

EQUATOR

Enrollment

131

Registered

2017-04-05

Start date

2017-03-09

Completion date

2018-03-12

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DRUGfilgotinib

one filgotinib oral tablet q.d.

DRUGPlacebo Oral Tablet

one placebo oral tablet q.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects who have reached ACR20 response as compared to placebo	Week 16	To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients

Secondary

Measure	Time frame	Description
Percentage of subjects who have reached ACR50 response as compared to placebo	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	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	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	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	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	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	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	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	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	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	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	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	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	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	At each visit from screening until the final follow up visit (week 20)	To assess the affect of filgotinib on PASI90 in PsA patients
Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo	At each visit from screening until the final follow up visit (week 20)	To assess the effect of filogotinib on MDA in PsA patients
Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo	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	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	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	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	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	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	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	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	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	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	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	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	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	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	From screening until the final follow up visit (week 20)	To evaluation safety and tolerability of filgotinib in PsA patients
Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo	At each visit from screening until the final follow up visit (week 20)	To assess the affect of filgotinib on PASI100 in PsA patients

Countries

Belgium, Bulgaria, Czechia, Estonia, Poland, Spain, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026