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Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Study acronym: SELECTIONLTE
StatusCompleted
PhasePhase 3
Started2017-02-23
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 67 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-18
Trial completed
2026-05-19
Study Status, Contacts/Locations v66
Study sitesdetails revised at 1 of 323 sites
2025-02-05
Study Status v65
Re-verified, no change to tracked fields
2024-09-23
Study Identification, Study Status, Sponsor/Collaborators v64
Lead sponsorLakefront Biotherapeutics NV→Alfasigma S.p.A.
2023-11-24
Study Status v63
Re-verified, no change to tracked fields
Show 45 earlier versions
2023-01-24
Study Status, Study Description, Eligibility v62
Primary completion date2026-10→2026-09
Completion date2026-11→2026-09
Eligibility criteria-10 characters
[...] Must have enrolled in Gilead-sponsored UC parent protocol GS- US- 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC Females of childbearing potential must have a negative pregnancy test at Day 1 Male and femaleFemale individuals of childbearing potential who engage in heteros [...] agree to use protocol specified method(s) of contraception as described in the protocol for the duration described Willingne [...] [...]
2022-12-21
Study Status v61
Re-verified, no change to tracked fields
2021-12-21
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v60
Primary completion date2023-11→2026-10
Completion date2023-12→2026-11
Lead sponsorGilead Sciences→Lakefront Biotherapeutics NV
Collaborators1 entry, revised
LakefrontGilead Biotherapeutics NVSciences
2021-11-11
Study Status v59
Re-verified, no change to tracked fields
2021-05-11
Study Status, Contacts/Locations v58
Study sitesdetails revised at 2 of 323 sites
2020-10-30
Study Status, Contacts/Locations v57
Study sitesdetails revised at 1 of 323 sites
2020-04-30
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v56
Trial statusEnrolling by Invitation→Active, Not Recruiting
Enrollment targetestimated 1000→confirmed 1173
Study sites453→323
2020-04-07
Study Status v55
Re-verified, no change to tracked fields
2020-03-20
Study Status, Contacts/Locations v54
Study sites454→453
2020-03-03
Study Status v53
Re-verified, no change to tracked fields
2020-02-14
Study Status, Arms and Interventions, Contacts/Locations v52
Primary completion date2026-10→2023-11
Completion date2026-11→2023-12
Study sites455→454
2020-01-21
Study Status, Contacts/Locations v51
Study sites455 entries, revised
ISCARE I.V.F. a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
2019-12-16
Study Status, Contacts/Locations v50
Study sites455 entries, revised
Center for Digestive Health Research Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. NorbertNorberta Barlickiego GASTROMED Kopon, ZmudzkinskiZmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
2019-11-18
Study Status, Contacts/Locations v49
Study sites455 entries, revised
Universitaetsklinik KoelnKoln
2019-11-05
Study Status v48
Re-verified, no change to tracked fields
2019-10-14
Study Status, Contacts/Locations v47
Study sites455 entries, revised
"Scientific Research Centre ECO-safety" LLC
2019-09-25
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v46
Primary completion date2023-02→2026-10
Completion date2023-03→2026-11
Secondary endpointsdetails revised at 1 of 1 entry
Study sites455 entries, revised
SaintScientific PetersburgResearch StateCentre BudgetECO-safety Healthcare Institution "City Hospital #26"LLC
2019-09-09
Study Status, Contacts/Locations v45
Study sites454→455
2019-08-08
Study Status, Contacts/Locations v44
Primary completion date2022-09→2023-02
Completion date2022-10→2023-03
Study sites454 entries, revised
Clinical Research Center Spolka z o.o.ograniczna odpowiedzialnoscia Medic-R Sp. k.
2019-07-15
Study Status, Contacts/Locations v43
Study sitesdetails revised at 1 of 454 sites
2019-06-25
Study Status, Contacts/Locations v42
Study sites454 entries, revised
UF HealthClinical atResearch ShandsCenter Del-pesti Hospital EgyesitettCentrumkorhaz Szent- IstvanOrszagos Hematologiai es SzentInfektologiai Laszlo Korhaz - Rendelointezet; Szent Laszlo Korhaz telephelyIntezet, Kozponti Felnott Szakrendelo
2019-05-09
Study Status, Contacts/Locations v41
Study sites454 entries, revised
Tibor Rubin VA MedicalLong CenterBeach Healthcare System KitakyusyuKitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
2019-04-26
Study Status, Contacts/Locations v40
Study sites454 entries, revised
Centrum MedyczyneMedyczne Oporow
2019-04-10
Study Status, Contacts/Locations v39
Study sites454 entries, revised
Florida Medical Clinic, P.A. GZA Ziekenhuizen, campus Sint-Vincentius Charite UniversitatsmedizinUniversitaetsmedizin Berlin Suretech Hospital and& Research Centre Ltd Kitasato University Hospital,THE KITASATO INSTITUTE Centrum Opieki Zdrowotnej "Orkan-Med" Stec-Michalska Sp. J. Centrum MedyczneMedyczyne Oporow UniversitatsspitalUniversitätsspital ZurichZürich Far-Eastern Memorial Hospital
2019-03-25
Study Status, Contacts/Locations v38
Study sites454 entries, revised
Emeritas Research Group LLC McguireMcGuire DVAMC
2019-03-08
Study Status, Contacts/Locations v37
Study sites453→454
2019-02-22
Study Status, Contacts/Locations v36
Study sitesdetails revised at 2 of 453 sites
2019-02-08
Study Status v35
Re-verified, no change to tracked fields
2019-01-09
Study Status, Eligibility, Contacts/Locations v34
Study sites452→453
Eligibility criteria+73 characters
[...] o initiation of study procedures associated with this trial Must have enrolled in Gilead-sponsored UC parent protocol GS-US-418-3898 Must have completed all required procedures or met protocol [...]
2018-12-11
Study Status, Contacts/Locations v33
Study sites435→452
2018-09-13
Study Status, Contacts/Locations v32
Study sites416→435
2018-08-10
Study Status, Contacts/Locations v31
Study sites405→416
2018-07-16
Study Status, Contacts/Locations v30
Study sites398→405
2018-06-19
Study Status, Contacts/Locations v29
Study sites394→398
2018-05-22
Study Status, Contacts/Locations v28
Study sites390→394
2018-05-01
Recruiting→Enrolling by Invitation Study Status, Eligibility, Contacts/Locations v27
Trial statusRecruiting→Enrolling by Invitation
Study sites384→390
Eligibility criteria+11 characters
[...] ohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would p [...]
2018-04-05
Study Status, Contacts/Locations v26
Study sites378→384
2018-03-22
Study Status, Contacts/Locations v25
Study sites370→378
2018-03-05
Study Status, Contacts/Locations v24
Study sites363→370
2018-02-14
Study Status, Contacts/Locations v23
Study sites352→363
2018-01-29
Study Status, Contacts/Locations v22
Study sites347→352
2018-01-11
Study Status, Contacts/Locations v21
Study sites339→347
2017-12-22
Study Status, Contacts/Locations v20
Study sites326→339
2017-12-07
Study Status, Contacts/Locations v19
Study sites314→326
2017-11-20
Study Status, Contacts/Locations v18
Study sites276→314
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Trial Details
NCT Number NCT02914535
Lead Sponsor Alfasigma S.p.A.
Collaborators: Gilead Sciences
Conditions Ulcerative Colitis
Enrollment 1,173 participants
Start Date 2017-02-23
Primary Completion 2026-09-08 (estimated)
Study Completion 2026-09-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-17