Clinical Trials List
2017-02-17 - 2020-12-17
Phase III
Recruiting9
Terminated3
ICD-10K50.90
Crohn's disease, unspecified, without complications
ICD-10K50
Crohn's disease [regional enteritis]
ICD-9555.9
Regional enteritis, unspecified site
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn's Disease
-
Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
-
Sponsor
Gilead Sciences
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 康瑞文 無
- Po-Wen Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 張安迪 未分科
- Jen-Wei Chou 無
- Tsung-Yu Tsai 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊純豪 無
- 姜正愷 無
- Chun-Chi Lin 無
- 王煥昇 無
- 張世慶 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-Lung Feng 未分科
Audit
None
Taiwan National PI
Co-Principal Investigator
- 陳聰興 無
- Puo-Hsien Le 未分科
- 陳俊瑋 無
- Cheng-Yu Lin 無
- 許振銘 無
- Chia-Jung Kuo 無
- Wen-Sy Tsai 無
- 林偉彬 無
- 林蔚然 無
- Ming-Yao Su 無
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
None
Chairman/Global PI
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- 謝銘鈞 未分科
- YEN-HSUAN NI 未分科
- 翁昭旼 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
the duration of the study. Safety evaluations include documentation of AEs,
PE (complete or symptom driven), vital signs, and clinical laboratory
evaluations (hematology, chemistry, urinalysis). An ECG will be performed
at screening, Week 10 (or at Early Termination (ET) if subject terminates
prior to Week 10), Week 26 and Week 58.
A data monitoring committee (DMC) will meet to evaluate all available
safety data accumulated during the study. The initial meeting will occur
after approximately 100 subjects reach Week 10 in Cohorts A and B
combined. Following this, subsequent meetings will occur approximately
once every 4 months.
Efficacy: Primary efficacy will be assessed by PRO2 and SES-CD (co-primary):
Clinical remission by PRO2 is defined as abdominal pain score ≤ 1
(on a scale of 0 to 3) AND stool frequency ≤ 3
Endoscopic response is defined as SES-CD score (based on central
reading) reduction of ≥ 50% from baseline
Pharmacokinetics: Plasma concentrations of filgotinib and its metabolite GS-829845
(formerly G254445) will be determined.
Biomarkers: Blood samples will be collected (predose if applicable) at Day 1and
Weeks 4, 10, 26, and 58 for assessment of markers of inflammation,
immune status, peripheral blood mononuclear cell (PBMC), and the Janus
Kinase-Signal Transducer and Activator of Transcription (JAK-STAT)
pathway. Histopathologic and immunohistochemistry (IHC) assessments
will be performed on biopsies at screening and Weeks 10 and 58.
Microbiome samples will be collected at screening and Weeks 10, 26, and
58. Genetic predisposition to disease and filgotinib treatment will be
assessed in the optional genomic substudy.
Inclution Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in either
the Cohort A or B Induction Study.
1) Must have the ability to understand and sign a written ICF, which must be obtained prior to
initiation of study procedures
2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the
date of the screening visit
3) Females of childbearing potential (as defined in Appendix 7) must have a negative pregnancy
test at screening and baseline
4) Male subjects and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as described in
Appendix 7
5) Documented diagnosis of CD with a minimum disease duration of 6 months with
involvement of the ileum and/or colon at a minimum, documented by the following:
i. Medical record documentation of, or an ileocolonoscopy (full colonoscopy with the
intubation of terminal ileum) report dated ≥ 6 months before enrollment, which shows
features consistent with CD, determined by the procedure performing physician AND
ii. Medical record documentation of or a histopathology report showing features consistent
with CD, determined by the pathologist.
6) Moderately or severely active CD as defined by:
i. CDAI total score between 220 and 450 inclusive (refer to Appendix 4), AND
ii. PRO2 score consisting of abdominal pain ≥ 2 (on CDAI scale of 0 to 3) OR daily stool
frequency ≥ 4 (refer to Appendix 4), AND
iii. Evidence of active disease as measured by SES-CD (refer to Appendix 5) based on
central reading:
a) Total score ≥ 6, OR
b) If disease is limited to the ileum and/or right colon, a combined score ≥ 4 in these
two segments
7) Meet one of the following TB screening criteria:
a) No evidence of active or latent TB ie,
i) A negative QuantiFERON®
TB-Gold In-Tube test at screening, AND
ii) A chest radiograph (views as per local guidelines) taken at screening or within the
3 months prior to screening (with the report or films available for investigator review)
without evidence of active or latent TB infection, AND
iii) No history of either untreated or inadequately treated latent or active TB infection
b) Previously treated for TB: ie, if a subject has previously received an adequate course of
therapy as per local standard of care for either latent TB (9 months of isoniazid in a
location where rates of primary multi-drug resistant TB infections are < 5% or an
acceptable alternative regimen) or active TB (acceptable multi-drug regimen). In these
cases, no QuantiFERON®
TB-Gold In-Tube test (or equivalent assay) need be obtained,
but a chest radiograph must be obtained if not done so within 3 months prior to screening
(with the report or films available for investigator review). It is the responsibility of the
investigator to verify the adequacy of previous anti-TB treatment and provide appropriate
documentation.
c) Newly identified latent TB during screening: ie, a subject who has a newly identified
positive diagnostic TB test result (defined as a positive QuantiFERON®
TB Gold in Tube
test [or equivalent assay]) in which active TB has been ruled out and for which
appropriate, ongoing, prophylactic treatment for latent TB has been initiated for a
minimum of 4 weeks prior to the first administration of study medication. Adequate
treatment for latent TB is defined according to local country guidelines for
immunocompromised subjects
Cases falling under category “b” and “c” need to be approved by the Sponsor prior to enrollment
in the study. No subject with currently ACTIVE TB may be enrolled in the study, regardless of
past or present anti-TB medication use.
8) Laboratory parameters (subjects who fail to meet below may be re-tested once at discretion
of investigator prior to being considered a screen failure):
i. Hepatic panel (AST, ALT, total bilirubin) ≤ 2 times ULN
ii. Estimated CrCl ≥ 40 ml/min as calculated by the CC&G equation
iii. Hemoglobin ≥ 8 g/dL (both males and females)
iv. Absolute neutrophil count (ANC) ≥ 1.5 × 109
/L (1,500/mm3
)
v. Platelets ≥ 100 × 109
/L
vi. White blood cells (WBC) ≥ 3.0 x 109
/L
vii. Absolute lymphocyte count >750/mm3
9) May be receiving the following drugs (subjects on these therapies must be willing to remain
on stable doses for the noted times):
a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose prescribed has been stable
for at least 4 weeks prior to randomization; dose must remain stable for the first 10 weeks
after randomization
b) Azathioprine or 6-MP or MTX provided the dose prescribed has been stable for 4 weeks
prior to randomization; dose must remain stable for the first 10 weeks after
randomization
c) Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or
budesonide prescribed at a stable dose of ≤ 9 mg/day) provided the dose prescribed has
been stable for 2 weeks prior to randomization; dose must remain stable for the
first 14 weeks after randomization
d) Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose
prescribed has been stable for 2 weeks prior to randomization. Dose must remain stable
for the first 10 weeks after randomization. Subjects who are on cyclic therapy must
continue their standard low-dose regimen without change for the first 10 weeks after
randomization.
10) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks
after last dose
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in either the
Cohort A or B induction study.
1) Pregnant or lactating females
2) Males and females of reproductive potential who are unwilling to abide by protocol-specified
contraceptive methods as defined by Appendix 7
3) 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
up to 35 days after the last dose of the study drug
4) Male subjects unwilling to refrain from sperm donation during the study and for at least
90 days after the last dose of study drug
5) Known hypersensitivity to filgotinib
6) Currently have complications of CD as any of the following:
a) Symptomatic strictures, OR
b) Severe (impassable) rectal/anal stenosis, OR
c) Fistulae, OR
d) Short bowel syndrome, OR
e) Any other complications which could preclude the use of the CDAI to assess response to
therapy, or would possibly confound the evaluation of benefit from treatment with
filgotinib
7) Have any current or prior abscesses, unless they have been drained and treated at least
6 weeks prior to Day 1 and are not anticipated to require surgery
8) History of major surgery or trauma within 30 days prior to screening
9) Presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
10) History of total colectomy, hemi-colectomy, presence of ileostomy or colostomy, or likely
requirement for surgery during the study
11) Dependence on parenteral nutrition
12) History or evidence of incompletely resected colonic mucosal dysplasia
13) Stool sample positive for Clostridium difficile (C. diff) toxin, Escherichia coli (E. coli),
Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp
14) Stool sample positive for ova and parasites test (O&P) unless approved by the medical
monitor
15) Active clinically significant infection or any infection requiring hospitalization or treatment
with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1); or any
infection requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of
Day 1)
16) Infection with HIV, hepatitis B, or hepatitis C
17) Presence of Child-Pugh Class C hepatic impairment
18) Active TB or history of latent TB that has not been treated (See inclusion criterion 7 for
further information)
19) History of malignancy within the last 5 years except for subjects who have been treated or
resected for non-melanoma skin cancer or cervical carcinoma in situ
20) History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder,
or multiple myeloma
21) History of treatment with lymphocyte-depleting therapies, including but not limited to
alemtuzumab, cyclophosphamide, total lymphoid irradiation, and rituximab
22) History of leukocytapheresis ≤ 6 months prior to screening
23) Use of any prohibited concomitant medications as described in Section 5.4.2
24) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease)
or psychiatric problem (including, but not limited to alcohol or drug abuse) that, in the
opinion of the Investigator, would make the subject unsuitable for the study or would prevent
compliance with the study protocol
25) Administration of a live or attenuated vaccine within 30 days of randomization
26) History of opportunistic infection or immunodeficiency syndrome
27) Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic
infection (such as pneumocystis (PCP), cytomegalovirus (CMV), herpes zoster, atypical
mycobacteria)
28) History of disseminated Staphylococcus aureus
29) History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any
history of disseminated herpes simplex, herpes zoster, ophthalmic zoster, or central nervous
system zoster
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
1320 participants
