OLINGUITO
Research type
Research Study
Full title
A Phase 3 randomized, placebo-controlled, double-blind, parallel-group program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis
IRAS ID
1006717
Contact name
Alexandra Mangili
Contact email
Sponsor organisation
Alfasigma S.p.A
Clinicaltrials.gov Identifier
Research summary
Axial spondyloarthritis (axSpA) is an inflammatory arthritis that causes pain and swelling in the spine and the joints that connect the bottom of the spine to the pelvis (sacroiliac joint). Other joints or body parts and organs can be affected as well. Current treatments can be effective in some patients but not in others. There is therefore a need for alternative treatments for patients who current medications don’t work.
The purpose of this study is to see whether the study drug (filgotinib) helps to treat axSpA and how safe it is in terms of side effects. Approximately 476 participants 18 years of age or older will participate across 20 countries globally and will receive the study drug daily as tablets to be swallowed.
The total study duration for each participant will be up to 113 weeks (17 standard hospital visits) as follows:
• Screening period (lasting up to 5 weeks)
• Treatment period (lasting up to 104 weeks)
• Safety follow-up period (lasting 4 weeks)The treatment period includes 3 parts where participants will receive:
• Part 1: 200mg of filgotinib or placebo
• Part 2: 200mg of filgotinib
• Part 3: 200mg or 100mg filgotinib
Placebo looks like the study drug but contains no active medication. It’s used to help determine if results are due to the study drug or something else. Neither participants nor the study doctor will know if they receive study drug or placebo. In Part 3, the study will be comparing 200mg with 100mg filgotinib a day to see if the lower dose also treats axSpA.
Participants may join an optional sub-study (add-on to the main study) that is measuring how filgotinib is taken up and broken down in the body. If they consent, they will give extra blood samples on 1 of the visits.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0041
Date of REC Opinion
24 Jul 2023
REC opinion
Further Information Favourable Opinion