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A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

NCT05785611 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2025-12-04

No results posted yet for this study

Summary

This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

Filgotinib

Tablets administered orally once daily

DRUG

Placebo

Tablets administered orally once daily

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Principal Investigators

  • Alfasigma Study Director · Alfasigma S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2024-09-04
Completion
2028-12-31

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05785611 on ClinicalTrials.gov