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

Study acronym: OLINGUITO
StatusActive, Not Recruiting
PhasePhase 3
Started2023-04-05
View on ClinicalTrials.gov ↗

Amendment history

2025-12-03
minor
Study Status, Contacts/Locations v17
Study sites125→123
2025-08-11
minor
Study Status, Arms and Interventions, Contacts/Locations v16
Completion date2026-07→2028-12
Study sites130→125
2024-12-13
minor
Study Identification, Study Status, Sponsor/Collaborators v15
Lead sponsorLakefront Biotherapeutics NV→Alfasigma S.p.A.
Study titlerevised
A Study Evaluating the Effect of Filgotinib in Participants withWith Active Axial Spondyloarthritis
2024-09-27
minor
Study Identification, Study Status, Study Design v14
Primary completion dateestimated 2024-09→confirmed 2024-09-04
Study titlerevised
A Study Evaluating the Effect of Filgotinib in Participants Withwith Active Axial Spondyloarthritis
2024-05-17
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-08→2024-09
Completion date2026-05→2026-07
Enrollment target476→495
Study sitesdetails revised at 130 of 130 sites
Show 12 earlier versions
2024-03-15
minor
Study Status, Contacts/Locations v12
Study sites129→130
2024-02-16
minor
Study Status, Contacts/Locations v11
Study sites128→129
2024-01-19
minor
Study Identification, Study Status, Contacts/Locations v10
Study sites126→128
2023-12-21
minor
Study Status, Contacts/Locations v9
Study sites124→126
2023-11-29
minor
Study Status, Contacts/Locations v8
Study sites116→124
2023-10-30
minor
Study Status, Eligibility, Contacts/Locations v7
Study sites102→116
Eligibility criteria+868 characters
[...] >=2 NSAIDs for the treatment of axSpA. Participants who are designated as biologic disease-modifying antirheumatic drug (BDMARD)(s) experienced; defined as below. Participants designated as bDMARD(s)-inadequate responder(bDMARD-IR) must have received not more than 2 approved bDMARD(s), that was/were administered in accordance with its/their labeling and was/werediscontinued inadequatelydue effectiveto: Non-response (primary or secondary) after thea minimum treatment of 12 weeks, and /or Intolerance (defined as having experienced an adverse reaction [e.g. an infusion/injection reaction, an inf [...] [...]
2023-09-29
minor
Study Status, Eligibility, Contacts/Locations v6
Study sites76→102
Eligibility criteria+24 characters
[...] ticipants aged 65 years or above on the date of signing the informed consent form (ICF), the investigator should carefully consider if participatio [...]
2023-09-01
minor
Study Status, Contacts/Locations v5
Study sites57→76
2023-08-01
minor
Study Identification, Study Status, Contacts/Locations v4
Study sites12→57
2023-06-02
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v3
Study sites6→12
Eligibility criteria+897 characters
[...] 2), Have a history of inadequate response to >=2 NSAIDs at athe therapeuticmaximum dose rangeof NSAIDs used in axSpA for >=2 weeks each (a total duration of NSAID trial >=4 wee [...] as no change in prescription) for >4 weeks prior to Day 1. For participants aged 65 years or above on the date of signing the ICF, the investigator should carefully consider if participation is in the best interest of the participant. Key Exclusion Criteria: Prior exposure to a Janus kinase inh [...] clinically significant, as per judgment of the investigator, or history of a serious infection (requiring hospitalization or sy [...] [...]
2023-05-03
minor
Study Status, Contacts/Locations v2
Study sites5→6
2023-04-06
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-04-05
Study sites2→5
Study title-10 characters
A Phase 3 ProgramStudy Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
2023-03-14
minor
Original filing
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.
Trial Details
NCT Number NCT05785611
Lead Sponsor Alfasigma S.p.A.
Conditions Axial Spondyloarthritis
Enrollment 495 participants
Start Date 2023-04-05
Primary Completion 2024-09-04 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-04