MedTrace Logo

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

NCT03320876 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-04-21

No results posted yet for this study

Summary

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

Conditions

Interventions

DRUG

filgotinib

one filgotinib oral tablet once daily.

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Vijay Rajendran, MD · Galapagos NV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320876 on ClinicalTrials.gov