An Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn*s Disease

Phase 3

Completed

Conditions: Crohn syndrome
regional enteritis
10017969

Registration Number: NL-OMON54703

Lead Sponsor: Galapagos NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1) Must have the ability to understand and sign a written informed consent form
(ICF), which must be obtained prior to initiation of study procedures
associated with this trial
2) Criterion modified per amendment 9
2.1) Must have enrolled in a CD parent protocol, GS-US-4194015, GS-US-419-4016
or GS-US-419-3895 or any other Gilead/Galapagos-sponsored filgotinib treatment
study for CD
3) 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
4) Criterion modified per amendment 9
4.1) 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 protocol
5) Willingness to refrain from live or attenuated vaccines during the study and
for 12 weeks after last dose of study drug
6) Must have completed all required procedures or met protocol specified
efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Exclusion Criteria

1) 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 this study
2) Known hypersensitivity to the study drug
3) 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
4) Criterion modified per amendment 9
4.1) 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 after the last dose of
study drug
5) Criterion deleted per amendment 9
6) Criterion deleted per amendment 9
6.1) Females of reproductive potential who are unwilling to abide by
protocol-specified contraceptive methods as defined in the protocol
7) Use of prohibited concomitant medications as outlined in Section 5.4.2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is safety. Safety will be evaluated through AEs, clinical<br /><br>laboratory tests, and vital signs. Safety endpoints will be analyzed by the<br /><br>number and percent of subjects with events or abnormalities for categorical<br /><br>values or standard descriptive statistics (n, mean, standard deviation [SD],<br /><br>median, 1st quartile [Q1], 3rd quartile [Q3], minimum, maximum) for continuous<br /><br>data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy endpoints of change from baseline in PRO2 and CDAI<br /><br>scores, and exploratory endpoints of change in HRQoL<br /><br>scores will be summarized using standard descriptive statistics (n, mean, SD,<br /><br>median, Q1, Q3, minimum, maximum).</p><br>