filgotinib for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial\n- Must have enrolled in Gilead-sponsored UC parent protocol GS-US-4183898 or any other Gilead/Galapagos-sponsored filgotinib treatment study in Ulcerative Colitis\n- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC\n- Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment\n- Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the clinical study protocol\n- Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug"}

Exclusion criteria

• {"criterion_text":"- Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study.\n- Known hypersensitivity to the study drug\n- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol\n- Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 30 days of the last dose of the study drug\n- Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug\n- Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods\n- Use of prohibited concomitant medications as outlined in the protocol"}

Primary endpoints

• {"endpoint_text":"- Safety, evaluated through AEs, clinical laboratory tests, and vital signs","definition_or_measurement_approach":"Safety evaluated through adverse events (AEs), clinical laboratory tests, and vital signs (as stated in the primary endpoint description)."}

Secondary endpoints

• {"endpoint_text":"- To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)","definition_or_measurement_approach":"Effect measured by change/evaluation in partial Mayo Clinic Score (MCS) (as stated in the secondary endpoint description)."}

Hungary

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

415

Number Of Sites

3

Number Of Participants

26

Primary sponsor

Full Name

Alfasigma S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Signant Health Management Limited

Responsibilities

Sponsor duties code(s): [{"id":983350,"code":"3"}]

Name

Labcorp Early Development Laboratories Inc.

Responsibilities

Sponsor duties code(s): [{"id":983349,"code":"4"}]

Name

Bioclinica Inc.

Responsibilities

Sponsor duties: clinical adjudication of cardiovascular events; provision of patient & site devices and other duties (codes: 15, 7)

Name

Icon Public Limited Company

Responsibilities

Sponsor duties codes: 1, 12, 2, 5 (as listed)

Third parties

• {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"[{\"id\":983350,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"[{\"id\":983349,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc. (Princeton address)","duties_or_roles":"[{\"id\":983342,\"code\":\"15\",\"value\":\"Clinical adjudication of cardiovascular events\"}]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioclinica Inc. (Philadelphia address)","duties_or_roles":"[{\"id\":983343,\"code\":\"15\",\"value\":\"Provide patient & site devices for collection of QOL questionnaires & patient reported outcomes\"},{\"id\":983344,\"code\":\"7\"}]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"[{\"id\":983345,\"code\":\"1\"},{\"id\":983346,\"code\":\"12\"},{\"id\":983347,\"code\":\"2\"},{\"id\":983348,\"code\":\"5\"}]","organisation_type":"Pharmaceutical company"}